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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00262600
Registration number
NCT00262600
Ethics application status
Date submitted
6/12/2005
Date registered
7/12/2005
Date last updated
17/04/2019
Titles & IDs
Public title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
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Scientific title
Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)
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Secondary ID [1]
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2005-003894-26
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Secondary ID [2]
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1160.26
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation
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Stroke
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Condition category
Condition code
Cardiovascular
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0
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - warfarin
Treatment: Drugs - Dabigatran dose 1
Treatment: Drugs - Dabigatran dose 2
Active comparator: Dabigatran dose 2 - twice a day
Active comparator: Warfarin - once a day
Active comparator: Dabigatran dose 1 - twice a day
Treatment: Drugs: warfarin
once a day
Treatment: Drugs: Dabigatran dose 1
twice daily
Treatment: Drugs: Dabigatran dose 2
twice a day
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Yearly Event Rate for Composite Endpoint of Stroke/SEE
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Assessment method [1]
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Time to first occurrence of stroke or systemic embolic event. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
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Timepoint [1]
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36 months
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Secondary outcome [1]
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Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death
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Assessment method [1]
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Time to first occurrence of stroke, SEE or all cause death. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
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Timepoint [1]
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36 months
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Secondary outcome [2]
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Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death
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Assessment method [2]
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Time to first occurrence of stroke, systemic embolic event, pulmonary embolism, myocardial infarction including silent myocardial infarction or vascular death. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25
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Timepoint [2]
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36 months
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Secondary outcome [3]
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Bleeding Events (Major and Minor)
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Assessment method [3]
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Yearly event rate of bleeds. Yearly event rate (%) = number of subjects with event / subject-years \* 100. Subject years = sum(date of study termination - date of randomization + 1) of all randomized subjects / 365.25 Major bleeds are adjudicated, whereas minor bleeds are investigator reported.
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Timepoint [3]
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36 months
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Secondary outcome [4]
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Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)
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Assessment method [4]
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Patients with clinical relevant abnormalities for intracerebral hemorrhage, other intracranial hemorrhage (ICH)
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Timepoint [4]
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36 months
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Secondary outcome [5]
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Abnormal Liver Function Test
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Assessment method [5]
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Number of subjects with abnormal liver function test (LFT), i.e., ALT/AST\>3xULN and total bilirubin \> 2 x ULN
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Timepoint [5]
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36 months
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Eligibility
Key inclusion criteria
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria
1. Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study
2. Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
3. Conditions associated with an increased risk of bleeding
4. Contraindication to warfarin treatment
5. Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
6. Plan to perform a pulmonary vein ablation or surgery for cure of the AF
7. Severe renal impairment (estimated creatinine clearance <=30 mL/min)
8. Active infective endocarditis
9. Active liver disease
10. Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study
11. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L)
12. Patients who have developed transaminase elevations upon exposure to ximelagatran
13. Patients who have received an investigational drug in the past 30 days or are participating in another drug study
14. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse)
15. Any known hypersensitivity to galactose if the warfarin used contains galactose.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
18113
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
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Recruitment hospital [1]
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1160.26.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
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Recruitment hospital [2]
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1160.26.0510 Boehringer Ingelheim Investigational Site - Gosford
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1160.26.0505 Boehringer Ingelheim Investigational Site - Herston
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1160.26.0506 Boehringer Ingelheim Investigational Site - Milton
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1160.26.0509 Boehringer Ingelheim Investigational Site - Ashford
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1160.26.0507 Boehringer Ingelheim Investigational Site - Launceston
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1160.26.0504 Boehringer Ingelheim Investigational Site - Box Hill
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1160.26.0501 Boehringer Ingelheim Investigational Site - Geelong
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Recruitment hospital [9]
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1160.26.0502 Boehringer Ingelheim Investigational Site - Parkville
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Recruitment hospital [10]
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1160.26.0503 Boehringer Ingelheim Investigational Site - Prahran
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Recruitment postcode(s) [1]
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- Coffs Harbour
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- Gosford
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- Herston
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- Milton
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- Ashford
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- Launceston
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- Box Hill
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- Geelong
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- Parkville
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Recruitment postcode(s) [10]
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- Prahran
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Recruitment outside Australia
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State/province [115]
0
0
Plzen-Bory
Query!
Country [116]
0
0
Czechia
Query!
State/province [116]
0
0
Pragha 9
Query!
Country [117]
0
0
Czechia
Query!
State/province [117]
0
0
Prague 5
Query!
Country [118]
0
0
Czechia
Query!
State/province [118]
0
0
Praha 6
Query!
Country [119]
0
0
Czechia
Query!
State/province [119]
0
0
Pribram
Query!
Country [120]
0
0
Czechia
Query!
State/province [120]
0
0
Usti nad Orlici
Query!
Country [121]
0
0
Denmark
Query!
State/province [121]
0
0
Aalborg
Query!
Country [122]
0
0
Denmark
Query!
State/province [122]
0
0
Aarhus C
Query!
Country [123]
0
0
Denmark
Query!
State/province [123]
0
0
Frederikssund
Query!
Country [124]
0
0
Denmark
Query!
State/province [124]
0
0
Helsingør
Query!
Country [125]
0
0
Denmark
Query!
State/province [125]
0
0
Herlev
Query!
Country [126]
0
0
Denmark
Query!
State/province [126]
0
0
Horsens
Query!
Country [127]
0
0
Denmark
Query!
State/province [127]
0
0
Hvidovre
Query!
Country [128]
0
0
Denmark
Query!
State/province [128]
0
0
Køge
Query!
Country [129]
0
0
Denmark
Query!
State/province [129]
0
0
Odense
Query!
Country [130]
0
0
Denmark
Query!
State/province [130]
0
0
Roskilde
Query!
Country [131]
0
0
Denmark
Query!
State/province [131]
0
0
Svendborg
Query!
Country [132]
0
0
Finland
Query!
State/province [132]
0
0
Espoo
Query!
Country [133]
0
0
Finland
Query!
State/province [133]
0
0
HUS
Query!
Country [134]
0
0
Finland
Query!
State/province [134]
0
0
Jyväskylä
Query!
Country [135]
0
0
Finland
Query!
State/province [135]
0
0
Kuopio
Query!
Country [136]
0
0
Finland
Query!
State/province [136]
0
0
Lappeenranta
Query!
Country [137]
0
0
Finland
Query!
State/province [137]
0
0
OYS
Query!
Country [138]
0
0
Finland
Query!
State/province [138]
0
0
Pori
Query!
Country [139]
0
0
Finland
Query!
State/province [139]
0
0
Tampere
Query!
Country [140]
0
0
Finland
Query!
State/province [140]
0
0
Turku
Query!
Country [141]
0
0
France
Query!
State/province [141]
0
0
ABBEVILLE cedex
Query!
Country [142]
0
0
France
Query!
State/province [142]
0
0
Angers
Query!
Country [143]
0
0
France
Query!
State/province [143]
0
0
Cholet
Query!
Country [144]
0
0
France
Query!
State/province [144]
0
0
Gap
Query!
Country [145]
0
0
France
Query!
State/province [145]
0
0
Grenoble
Query!
Country [146]
0
0
France
Query!
State/province [146]
0
0
Joue les Tours
Query!
Country [147]
0
0
France
Query!
State/province [147]
0
0
Joué les Tours
Query!
Country [148]
0
0
France
Query!
State/province [148]
0
0
Langres
Query!
Country [149]
0
0
France
Query!
State/province [149]
0
0
Paris
Query!
Country [150]
0
0
France
Query!
State/province [150]
0
0
TOULOUSE cedex
Query!
Country [151]
0
0
France
Query!
State/province [151]
0
0
Tourcoing
Query!
Country [152]
0
0
France
Query!
State/province [152]
0
0
VALENCIENNES cedex
Query!
Country [153]
0
0
France
Query!
State/province [153]
0
0
Valenciennes cedex
Query!
Country [154]
0
0
France
Query!
State/province [154]
0
0
Valenciennes
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Berlin
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Bochum
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Coburg
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Dachau
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Dortmund
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Duisburg
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Erlangen
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Eschweiler
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Essen
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Frankfurt/Main
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Heidelberg
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Kassel
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
Köln
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Lahr
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Limburg
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Mainz
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Mannheim
Query!
Country [172]
0
0
Germany
Query!
State/province [172]
0
0
München
Query!
Country [173]
0
0
Germany
Query!
State/province [173]
0
0
Papenburg
Query!
Country [174]
0
0
Germany
Query!
State/province [174]
0
0
Suhl
Query!
Country [175]
0
0
Germany
Query!
State/province [175]
0
0
Witten
Query!
Country [176]
0
0
Germany
Query!
State/province [176]
0
0
Wuppertal
Query!
Country [177]
0
0
Greece
Query!
State/province [177]
0
0
Alexandroupolis
Query!
Country [178]
0
0
Greece
Query!
State/province [178]
0
0
Athens
Query!
Country [179]
0
0
Greece
Query!
State/province [179]
0
0
Kalamaria-Thessaloniki
Query!
Country [180]
0
0
Greece
Query!
State/province [180]
0
0
Larissa
Query!
Country [181]
0
0
Greece
Query!
State/province [181]
0
0
Leivadia
Query!
Country [182]
0
0
Greece
Query!
State/province [182]
0
0
Thessaloniki
Query!
Country [183]
0
0
Greece
Query!
State/province [183]
0
0
Thiva
Query!
Country [184]
0
0
Greece
Query!
State/province [184]
0
0
Trikala
Query!
Country [185]
0
0
Greece
Query!
State/province [185]
0
0
Voula - Athens
Query!
Country [186]
0
0
Hong Kong
Query!
State/province [186]
0
0
Hong Kong
Query!
Country [187]
0
0
Hong Kong
Query!
State/province [187]
0
0
Kowloon
Query!
Country [188]
0
0
Hungary
Query!
State/province [188]
0
0
Budapest
Query!
Country [189]
0
0
Hungary
Query!
State/province [189]
0
0
Gyongyos
Query!
Country [190]
0
0
Hungary
Query!
State/province [190]
0
0
Komarom
Query!
Country [191]
0
0
Hungary
Query!
State/province [191]
0
0
Pecs
Query!
Country [192]
0
0
Hungary
Query!
State/province [192]
0
0
Veszprem
Query!
Country [193]
0
0
India
Query!
State/province [193]
0
0
Ahmedabad
Query!
Country [194]
0
0
India
Query!
State/province [194]
0
0
Bangalore
Query!
Country [195]
0
0
India
Query!
State/province [195]
0
0
Bikaner
Query!
Country [196]
0
0
India
Query!
State/province [196]
0
0
Chennai
Query!
Country [197]
0
0
India
Query!
State/province [197]
0
0
Coimbatore
Query!
Country [198]
0
0
India
Query!
State/province [198]
0
0
Hyderabad
Query!
Country [199]
0
0
India
Query!
State/province [199]
0
0
Indore
Query!
Country [200]
0
0
India
Query!
State/province [200]
0
0
Jaipur
Query!
Country [201]
0
0
India
Query!
State/province [201]
0
0
Kerala
Query!
Country [202]
0
0
India
Query!
State/province [202]
0
0
Kottayam
Query!
Country [203]
0
0
India
Query!
State/province [203]
0
0
Lucknow
Query!
Country [204]
0
0
India
Query!
State/province [204]
0
0
Ludhiana
Query!
Country [205]
0
0
India
Query!
State/province [205]
0
0
Mumbai
Query!
Country [206]
0
0
India
Query!
State/province [206]
0
0
Mysore
Query!
Country [207]
0
0
India
Query!
State/province [207]
0
0
Nagpur
Query!
Country [208]
0
0
India
Query!
State/province [208]
0
0
New Delhi
Query!
Country [209]
0
0
India
Query!
State/province [209]
0
0
Pune
Query!
Country [210]
0
0
Israel
Query!
State/province [210]
0
0
Afula
Query!
Country [211]
0
0
Israel
Query!
State/province [211]
0
0
Ashkelon
Query!
Country [212]
0
0
Israel
Query!
State/province [212]
0
0
Be´er Scheva
Query!
Country [213]
0
0
Israel
Query!
State/province [213]
0
0
Givatayim
Query!
Country [214]
0
0
Israel
Query!
State/province [214]
0
0
Hadera
Query!
Country [215]
0
0
Israel
Query!
State/province [215]
0
0
Haifa
Query!
Country [216]
0
0
Israel
Query!
State/province [216]
0
0
Holon
Query!
Country [217]
0
0
Israel
Query!
State/province [217]
0
0
Jerusalem
Query!
Country [218]
0
0
Israel
Query!
State/province [218]
0
0
Kfar Saba
Query!
Country [219]
0
0
Israel
Query!
State/province [219]
0
0
Nazareth
Query!
Country [220]
0
0
Israel
Query!
State/province [220]
0
0
Petah Tikva
Query!
Country [221]
0
0
Israel
Query!
State/province [221]
0
0
Ramat Gan
Query!
Country [222]
0
0
Israel
Query!
State/province [222]
0
0
Rehovot
Query!
Country [223]
0
0
Israel
Query!
State/province [223]
0
0
Safed
Query!
Country [224]
0
0
Israel
Query!
State/province [224]
0
0
Tel Hashomer
Query!
Country [225]
0
0
Israel
Query!
State/province [225]
0
0
Tel-Aviv
Query!
Country [226]
0
0
Israel
Query!
State/province [226]
0
0
Zerifin
Query!
Country [227]
0
0
Italy
Query!
State/province [227]
0
0
Arezzo
Query!
Country [228]
0
0
Italy
Query!
State/province [228]
0
0
Ascoli Piceno
Query!
Country [229]
0
0
Italy
Query!
State/province [229]
0
0
Bentivoglio (BO)
Query!
Country [230]
0
0
Italy
Query!
State/province [230]
0
0
Bologna
Query!
Country [231]
0
0
Italy
Query!
State/province [231]
0
0
Castelnuovo Garfagnana
Query!
Country [232]
0
0
Italy
Query!
State/province [232]
0
0
Chieti
Query!
Country [233]
0
0
Italy
Query!
State/province [233]
0
0
Colleferro
Query!
Country [234]
0
0
Italy
Query!
State/province [234]
0
0
Cremona
Query!
Country [235]
0
0
Italy
Query!
State/province [235]
0
0
Eboli
Query!
Country [236]
0
0
Italy
Query!
State/province [236]
0
0
Isernia
Query!
Country [237]
0
0
Italy
Query!
State/province [237]
0
0
Legnago
Query!
Country [238]
0
0
Italy
Query!
State/province [238]
0
0
Mantova
Query!
Country [239]
0
0
Italy
Query!
State/province [239]
0
0
Perugia SAN Sisto
Query!
Country [240]
0
0
Italy
Query!
State/province [240]
0
0
Roma
Query!
Country [241]
0
0
Italy
Query!
State/province [241]
0
0
San Bonifacio
Query!
Country [242]
0
0
Italy
Query!
State/province [242]
0
0
San Daniele Del Friuli
Query!
Country [243]
0
0
Italy
Query!
State/province [243]
0
0
Sassari
Query!
Country [244]
0
0
Japan
Query!
State/province [244]
0
0
Abeno-ku, Osaka, Osaka
Query!
Country [245]
0
0
Japan
Query!
State/province [245]
0
0
Aki-gun, Hiroshima
Query!
Country [246]
0
0
Japan
Query!
State/province [246]
0
0
Aoba-ku, Sendai, Miyagi
Query!
Country [247]
0
0
Japan
Query!
State/province [247]
0
0
Chuo-ku, Fukuoka, Fukuoka
Query!
Country [248]
0
0
Japan
Query!
State/province [248]
0
0
Chuo-ku, Kobe, Hyogo
Query!
Country [249]
0
0
Japan
Query!
State/province [249]
0
0
Chuo-ku, Osaka, Osaka
Query!
Country [250]
0
0
Japan
Query!
State/province [250]
0
0
Fujioka-shi , Gunma-ken
Query!
Country [251]
0
0
Japan
Query!
State/province [251]
0
0
Fukushima-shi,Fukushima-ken
Query!
Country [252]
0
0
Japan
Query!
State/province [252]
0
0
Higashimatsushimashi, Miyagi-ken
Query!
Country [253]
0
0
Japan
Query!
State/province [253]
0
0
Himeji, Hyogo
Query!
Country [254]
0
0
Japan
Query!
State/province [254]
0
0
Iida, Nagano
Query!
Country [255]
0
0
Japan
Query!
State/province [255]
0
0
Isesaki-shi,Gunma
Query!
Country [256]
0
0
Japan
Query!
State/province [256]
0
0
Iwakuni, Yamaguchi
Query!
Country [257]
0
0
Japan
Query!
State/province [257]
0
0
Izumi-ku, Sendai, Miyagi
Query!
Country [258]
0
0
Japan
Query!
State/province [258]
0
0
Kamigyo-ku, Kyoto
Query!
Country [259]
0
0
Japan
Query!
State/province [259]
0
0
Kawachinagano, Osaka
Query!
Country [260]
0
0
Japan
Query!
State/province [260]
0
0
Kita-ku, Osaka, Osaka
Query!
Country [261]
0
0
Japan
Query!
State/province [261]
0
0
Kita-ku, Sakai, Osaka
Query!
Country [262]
0
0
Japan
Query!
State/province [262]
0
0
Komatsu-shi,Ishikawa -ken
Query!
Country [263]
0
0
Japan
Query!
State/province [263]
0
0
Kyoto-shi,Kyoto
Query!
Country [264]
0
0
Japan
Query!
State/province [264]
0
0
Matsumoto, Nagano
Query!
Country [265]
0
0
Japan
Query!
State/province [265]
0
0
Minami-ku, Fukuoka, Fukuoka
Query!
Country [266]
0
0
Japan
Query!
State/province [266]
0
0
Minato, Tokyo
Query!
Country [267]
0
0
Japan
Query!
State/province [267]
0
0
Minato-ku, Nagoya, Aichi
Query!
Country [268]
0
0
Japan
Query!
State/province [268]
0
0
Narashino, Chiba
Query!
Country [269]
0
0
Japan
Query!
State/province [269]
0
0
Nishinomiya-shi,Hyogo
Query!
Country [270]
0
0
Japan
Query!
State/province [270]
0
0
Okayama, Okayama
Query!
Country [271]
0
0
Japan
Query!
State/province [271]
0
0
Oota, Tokyo
Query!
Country [272]
0
0
Japan
Query!
State/province [272]
0
0
Otaru, Hokkaido
Query!
Country [273]
0
0
Japan
Query!
State/province [273]
0
0
Sagamihara, Kanagawa-ken
Query!
Country [274]
0
0
Japan
Query!
State/province [274]
0
0
Sapporo-shi,Hokkai-do
Query!
Country [275]
0
0
Japan
Query!
State/province [275]
0
0
Shibuya, Tokyo
Query!
Country [276]
0
0
Japan
Query!
State/province [276]
0
0
Shinjuku, Tokyo
Query!
Country [277]
0
0
Japan
Query!
State/province [277]
0
0
Shiroishi-ku, Sapporo, Hokkaido
Query!
Country [278]
0
0
Japan
Query!
State/province [278]
0
0
Suita, Osaka
Query!
Country [279]
0
0
Japan
Query!
State/province [279]
0
0
Suita-shi, Osaka
Query!
Country [280]
0
0
Japan
Query!
State/province [280]
0
0
Sumiyoshi-ku, Osaka, Osaka
Query!
Country [281]
0
0
Japan
Query!
State/province [281]
0
0
Takatsuki-shi,Osaka
Query!
Country [282]
0
0
Japan
Query!
State/province [282]
0
0
Tokorozawa, Saitama
Query!
Country [283]
0
0
Japan
Query!
State/province [283]
0
0
Totsuka-ku, Yokohama, Kanagawa
Query!
Country [284]
0
0
Japan
Query!
State/province [284]
0
0
Tsuchiura, Ibaragi
Query!
Country [285]
0
0
Japan
Query!
State/province [285]
0
0
Ueda, Nagano
Query!
Country [286]
0
0
Japan
Query!
State/province [286]
0
0
Wakayama, Wakayama
Query!
Country [287]
0
0
Japan
Query!
State/province [287]
0
0
Yanagawa, Fukuoka
Query!
Country [288]
0
0
Japan
Query!
State/province [288]
0
0
Yao, Osaka
Query!
Country [289]
0
0
Korea, Republic of
Query!
State/province [289]
0
0
Busan
Query!
Country [290]
0
0
Korea, Republic of
Query!
State/province [290]
0
0
Chungchungnam-Do
Query!
Country [291]
0
0
Korea, Republic of
Query!
State/province [291]
0
0
Daegu
Query!
Country [292]
0
0
Korea, Republic of
Query!
State/province [292]
0
0
Gwangju
Query!
Country [293]
0
0
Korea, Republic of
Query!
State/province [293]
0
0
Incheon
Query!
Country [294]
0
0
Korea, Republic of
Query!
State/province [294]
0
0
Seoul
Query!
Country [295]
0
0
Malaysia
Query!
State/province [295]
0
0
Kajang,Selangor
Query!
Country [296]
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Northampton
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Stoke-On-Trent
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United Kingdom
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York
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Boehringer Ingelheim
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Address
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Other collaborator category [1]
0
0
Other
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Population Health Research Institute
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Other
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Uppsala University
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Ethics approval
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Summary
Brief summary
The primary objective of this trial is to demonstrate the efficacy and safety of dabigatran etexilate in patients with non-valvular atrial fibrillation for the prevention of stroke and systemic embolism.
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Trial website
https://clinicaltrials.gov/study/NCT00262600
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Trial related presentations / publications
Reinhardt SW, Desai NR, Tang Y, Jones PG, Ader J, Spertus JA. Personalizing the decision of dabigatran versus warfarin in atrial fibrillation: A secondary analysis of the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) trial. PLoS One. 2021 Aug 19;16(8):e0256338. doi: 10.1371/journal.pone.0256338. eCollection 2021. Pol T, Hijazi Z, Lindback J, Oldgren J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Siegbahn A, Wallentin L. Using multimarker screening to identify biomarkers associated with cardiovascular death in patients with atrial fibrillation. Cardiovasc Res. 2022 Jul 20;118(9):2112-2123. doi: 10.1093/cvr/cvab262. Millenaar D, Schumacher H, Brueckmann M, Eikelboom JW, Ezekowitz M, Slawik J, Ewen S, Ukena C, Wallentin L, Connolly S, Yusuf S, Bohm M. Cardiovascular Outcomes According to Polypharmacy and Drug Adherence in Patients with Atrial Fibrillation on Long-Term Anticoagulation (from the RE-LY Trial). Am J Cardiol. 2021 Jun 15;149:27-35. doi: 10.1016/j.amjcard.2021.03.024. Epub 2021 Mar 20. Pol T, Hijazi Z, Lindback J, Alexander JH, Bahit MC, De Caterina R, Eikelboom JW, Ezekowitz MD, Gersh BJ, Granger CB, Hylek EM, Lopes R, Siegbahn A, Wallentin L. Evaluation of the prognostic value of GDF-15, ABC-AF-bleeding score and ABC-AF-death score in patients with atrial fibrillation across different geographical areas. Open Heart. 2021 Mar;8(1):e001471. doi: 10.1136/openhrt-2020-001471. Hijazi Z, Wallentin L, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Pol T, Yusuf S, Oldgren J, Siegbahn A. Screening of Multiple Biomarkers Associated With Ischemic Stroke in Atrial Fibrillation. J Am Heart Assoc. 2020 Dec 15;9(24):e018984. doi: 10.1161/JAHA.120.018984. Epub 2020 Dec 9. Wallentin L, Lindback J, Eriksson N, Hijazi Z, Eikelboom JW, Ezekowitz MD, Granger CB, Lopes RD, Yusuf S, Oldgren J, Siegbahn A. Angiotensin-converting enzyme 2 (ACE2) levels in relation to risk factors for COVID-19 in two large cohorts of patients with atrial fibrillation. Eur Heart J. 2020 Nov 1;41(41):4037-4046. doi: 10.1093/eurheartj/ehaa697. Bohm M, Brueckmann M, Eikelboom JW, Ezekowitz M, Frassdorf M, Hijazi Z, Hohnloser SH, Mahfoud F, Schmieder RE, Schumacher H, Wallentin L, Yusuf S. Cardiovascular outcomes, bleeding risk, and achieved blood pressure in patients on long-term anticoagulation with the thrombin antagonist dabigatran or warfarin: data from the RE-LY trial. Eur Heart J. 2020 Aug 7;41(30):2848-2859. doi: 10.1093/eurheartj/ehaa247. Stam-Slob MC, Connolly SJ, van der Graaf Y, van der Leeuw J, Dorresteijn JAN, Eikelboom JW, Peters RJG, Alings M, Visseren FLJ. Individual Treatment Effect Estimation of 2 Doses of Dabigatran on Stroke and Major Bleeding in Atrial Fibrillation. Circulation. 2019 Jun 18;139(25):2846-2856. doi: 10.1161/CIRCULATIONAHA.118.035266. Epub 2019 May 3. Hijazi Z, Verdecchia P, Oldgren J, Andersson U, Reboldi G, Di Pasquale G, Mazzotta G, Angeli F, Eikelboom JW, Ezekowitz MD, Connolly SJ, Yusuf S, Wallentin L. Cardiac Biomarkers and Left Ventricular Hypertrophy in Relation to Outcomes in Patients With Atrial Fibrillation: Experiences From the RE - LY Trial. J Am Heart Assoc. 2019 Jan 22;8(2):e010107. doi: 10.1161/JAHA.118.010107. Kent AP, Brueckmann M, Fraessdorf M, Connolly SJ, Yusuf S, Eikelboom JW, Oldgren J, Reilly PA, Wallentin L, Ezekowitz MD. Concomitant Oral Anticoagulant and Nonsteroidal Anti-Inflammatory Drug Therapy in Patients With Atrial Fibrillation. J Am Coll Cardiol. 2018 Jul 17;72(3):255-267. doi: 10.1016/j.jacc.2018.04.063. Epub 2018 Jul 9. Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Yusuf S, Wallentin L. Efficacy and safety of dabigatran compared with warfarin in patients with atrial fibrillation in relation to renal function over time-A RE-LY trial analysis. Am Heart J. 2018 Apr;198:169-177. doi: 10.1016/j.ahj.2017.10.015. Epub 2018 Jan 5. No abstract available. Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Yusuf S, Granger CB, Siegbahn A, Wallentin L; ARISTOTLE and RE-LY Investigators. A biomarker-based risk score to predict death in patients with atrial fibrillation: the ABC (age, biomarkers, clinical history) death risk score. Eur Heart J. 2018 Feb 7;39(6):477-485. doi: 10.1093/eurheartj/ehx584. Verdecchia P, Reboldi G, Angeli F, Mazzotta G, Lip GYH, Brueckmann M, Kleine E, Wallentin L, Ezekowitz MD, Yusuf S, Connolly SJ, Di Pasquale G. Dabigatran vs. warfarin in relation to the presence of left ventricular hypertrophy in patients with atrial fibrillation- the Randomized Evaluation of Long-term anticoagulation therapY (RE-LY) study. Europace. 2018 Feb 1;20(2):253-262. doi: 10.1093/europace/eux022. Lauw MN, Eikelboom JW, Coppens M, Wallentin L, Yusuf S, Ezekowitz M, Oldgren J, Nakamya J, Wang J, Connolly SJ. Effects of dabigatran according to age in atrial fibrillation. Heart. 2017 Jul;103(13):1015-1023. doi: 10.1136/heartjnl-2016-310358. Epub 2017 Feb 17. Oldgren J, Hijazi Z, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Granger CB, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Wallentin L; RE-LY and ARISTOTLE Investigators. Performance and Validation of a Novel Biomarker-Based Stroke Risk Score for Atrial Fibrillation. Circulation. 2016 Nov 29;134(22):1697-1707. doi: 10.1161/CIRCULATIONAHA.116.022802. Epub 2016 Aug 28. Ezekowitz MD, Nagarakanti R, Noack H, Brueckmann M, Litherland C, Jacobs M, Clemens A, Reilly PA, Connolly SJ, Yusuf S, Wallentin L. Comparison of Dabigatran and Warfarin in Patients With Atrial Fibrillation and Valvular Heart Disease: The RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulant Therapy). Circulation. 2016 Aug 23;134(8):589-98. doi: 10.1161/CIRCULATIONAHA.115.020950. Epub 2016 Aug 5. Hijazi Z, Oldgren J, Lindback J, Alexander JH, Connolly SJ, Eikelboom JW, Ezekowitz MD, Held C, Hylek EM, Lopes RD, Siegbahn A, Yusuf S, Granger CB, Wallentin L; ARISTOTLE and RE-LY Investigators. The novel biomarker-based ABC (age, biomarkers, clinical history)-bleeding risk score for patients with atrial fibrillation: a derivation and validation study. Lancet. 2016 Jun 4;387(10035):2302-2311. doi: 10.1016/S0140-6736(16)00741-8. Epub 2016 Apr 4. Siegbahn A, Oldgren J, Andersson U, Ezekowitz MD, Reilly PA, Connolly SJ, Yusuf S, Wallentin L, Eikelboom JW. D-dimer and factor VIIa in atrial fibrillation - prognostic values for cardiovascular events and effects of anticoagulation therapy. A RE-LY substudy. Thromb Haemost. 2016 May 2;115(5):921-30. doi: 10.1160/TH15-07-0529. Epub 2016 Jan 28. Aulin J, Siegbahn A, Hijazi Z, Ezekowitz MD, Andersson U, Connolly SJ, Huber K, Reilly PA, Wallentin L, Oldgren J. Interleukin-6 and C-reactive protein and risk for death and cardiovascular events in patients with atrial fibrillation. Am Heart J. 2015 Dec;170(6):1151-60. doi: 10.1016/j.ahj.2015.09.018. Epub 2015 Oct 3. Brambatti M, Darius H, Oldgren J, Clemens A, Noack HH, Brueckmann M, Yusuf S, Wallentin L, Ezekowitz MD, Connolly SJ, Healey JS. Comparison of dabigatran versus warfarin in diabetic patients with atrial fibrillation: Results from the RE-LY trial. Int J Cardiol. 2015 Oct 1;196:127-31. doi: 10.1016/j.ijcard.2015.05.141. Epub 2015 May 28. Bohm M, Ezekowitz MD, Connolly SJ, Eikelboom JW, Hohnloser SH, Reilly PA, Schumacher H, Brueckmann M, Schirmer SH, Kratz MT, Yusuf S, Diener HC, Hijazi Z, Wallentin L. Changes in Renal Function in Patients With Atrial Fibrillation: An Analysis From the RE-LY Trial. J Am Coll Cardiol. 2015 Jun 16;65(23):2481-93. doi: 10.1016/j.jacc.2015.03.577. Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Siegbahn A, Yusuf S, Wallentin L. Importance of persistent elevation of cardiac biomarkers in atrial fibrillation: a RE-LY substudy. Heart. 2014 Aug;100(15):1193-200. doi: 10.1136/heartjnl-2013-304872. Epub 2014 May 2. Verdecchia P, Reboldi G, Di Pasquale G, Mazzotta G, Ambrosio G, Yang S, Pogue J, Wallentin L, Ezekowitz MD, Connolly SJ, Yusuf S; RE-LY Study Investigators. Prognostic usefulness of left ventricular hypertrophy by electrocardiography in patients with atrial fibrillation (from the Randomized Evaluation of Long-Term Anticoagulant Therapy Study). Am J Cardiol. 2014 Feb 15;113(4):669-75. doi: 10.1016/j.amjcard.2013.10.045. Epub 2013 Nov 23. Hijazi Z, Hohnloser SH, Oldgren J, Andersson U, Connolly SJ, Eikelboom JW, Ezekowitz MD, Reilly PA, Siegbahn A, Yusuf S, Wallentin L. Efficacy and safety of dabigatran compared with warfarin in relation to baseline renal function in patients with atrial fibrillation: a RE-LY (Randomized Evaluation of Long-term Anticoagulation Therapy) trial analysis. Circulation. 2014 Mar 4;129(9):961-70. doi: 10.1161/CIRCULATIONAHA.113.003628. Epub 2013 Dec 9. Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30. Reilly PA, Lehr T, Haertter S, Connolly SJ, Yusuf S, Eikelboom JW, Ezekowitz MD, Nehmiz G, Wang S, Wallentin L; RE-LY Investigators. The effect of dabigatran plasma concentrations and patient characteristics on the frequency of ischemic stroke and major bleeding in atrial fibrillation patients: the RE-LY Trial (Randomized Evaluation of Long-Term Anticoagulation Therapy). J Am Coll Cardiol. 2014 Feb 4;63(4):321-8. doi: 10.1016/j.jacc.2013.07.104. Epub 2013 Sep 27. Marijon E, Le Heuzey JY, Connolly S, Yang S, Pogue J, Brueckmann M, Eikelboom J, Themeles E, Ezekowitz M, Wallentin L, Yusuf S; RE-LY Investigators. Causes of death and influencing factors in patients with atrial fibrillation: a competing-risk analysis from the randomized evaluation of long-term anticoagulant therapy study. Circulation. 2013 Nov 12;128(20):2192-201. doi: 10.1161/CIRCULATIONAHA.112.000491. Epub 2013 Sep 9. Eikelboom JW, Connolly SJ, Hart RG, Wallentin L, Reilly P, Oldgren J, Yang S, Yusuf S. Balancing the benefits and risks of 2 doses of dabigatran compared with warfarin in atrial fibrillation. J Am Coll Cardiol. 2013 Sep 3;62(10):900-8. doi: 10.1016/j.jacc.2013.05.042. Epub 2013 Jun 13. Hori M, Connolly SJ, Zhu J, Liu LS, Lau CP, Pais P, Xavier D, Kim SS, Omar R, Dans AL, Tan RS, Chen JH, Tanomsup S, Watanabe M, Koyanagi M, Ezekowitz MD, Reilly PA, Wallentin L, Yusuf S; RE-LY Investigators. Dabigatran versus warfarin: effects on ischemic and hemorrhagic strokes and bleeding in Asians and non-Asians with atrial fibrillation. Stroke. 2013 Jul;44(7):1891-6. doi: 10.1161/STROKEAHA.113.000990. Epub 2013 Jun 6. Pare G, Eriksson N, Lehr T, Connolly S, Eikelboom J, Ezekowitz MD, Axelsson T, Haertter S, Oldgren J, Reilly P, Siegbahn A, Syvanen AC, Wadelius C, Wadelius M, Zimdahl-Gelling H, Yusuf S, Wallentin L. Genetic determinants of dabigatran plasma levels and their relation to bleeding. Circulation. 2013 Apr 2;127(13):1404-12. doi: 10.1161/CIRCULATIONAHA.112.001233. Epub 2013 Mar 6. Dans AL, Connolly SJ, Wallentin L, Yang S, Nakamya J, Brueckmann M, Ezekowitz M, Oldgren J, Eikelboom JW, Reilly PA, Yusuf S. Concomitant use of antiplatelet therapy with dabigatran or warfarin in the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) trial. Circulation. 2013 Feb 5;127(5):634-40. doi: 10.1161/CIRCULATIONAHA.112.115386. Epub 2012 Dec 27. Bytzer P, Connolly SJ, Yang S, Ezekowitz M, Formella S, Reilly PA, Aisenberg J. Analysis of upper gastrointestinal adverse events among patients given dabigatran in the RE-LY trial. Clin Gastroenterol Hepatol. 2013 Mar;11(3):246-52.e1-5. doi: 10.1016/j.cgh.2012.10.021. Epub 2012 Oct 24. Van Spall HG, Wallentin L, Yusuf S, Eikelboom JW, Nieuwlaat R, Yang S, Kabali C, Reilly PA, Ezekowitz MD, Connolly SJ. Variation in warfarin dose adjustment practice is responsible for differences in the quality of anticoagulation control between centers and countries: an analysis of patients receiving warfarin in the randomized evaluation of long-term anticoagulation therapy (RE-LY) trial. Circulation. 2012 Nov 6;126(19):2309-16. doi: 10.1161/CIRCULATIONAHA.112.101808. Epub 2012 Oct 1. Healey JS, Eikelboom J, Douketis J, Wallentin L, Oldgren J, Yang S, Themeles E, Heidbuchel H, Avezum A, Reilly P, Connolly SJ, Yusuf S, Ezekowitz M; RE-LY Investigators. Periprocedural bleeding and thromboembolic events with dabigatran compared with warfarin: results from the Randomized Evaluation of Long-Term Anticoagulation Therapy (RE-LY) randomized trial. Circulation. 2012 Jul 17;126(3):343-8. doi: 10.1161/CIRCULATIONAHA.111.090464. Epub 2012 Jun 14. Erratum In: Circulation. 2012 Sep 4;126(10):e160. Heidbuchle, Hein [corrected to Heidbuchel, Hein]. Hijazi Z, Oldgren J, Andersson U, Connolly SJ, Ezekowitz MD, Hohnloser SH, Reilly PA, Vinereanu D, Siegbahn A, Yusuf S, Wallentin L. Cardiac biomarkers are associated with an increased risk of stroke and death in patients with atrial fibrillation: a Randomized Evaluation of Long-term Anticoagulation Therapy (RE-LY) substudy. Circulation. 2012 Apr 3;125(13):1605-16. doi: 10.1161/CIRCULATIONAHA.111.038729. Epub 2012 Feb 28. Hohnloser SH, Oldgren J, Yang S, Wallentin L, Ezekowitz M, Reilly P, Eikelboom J, Brueckmann M, Yusuf S, Connolly SJ. Myocardial ischemic events in patients with atrial fibrillation treated with dabigatran or warfarin in the RE-LY (Randomized Evaluation of Long-Term Anticoagulation Therapy) trial. Circulation. 2012 Feb 7;125(5):669-76. doi: 10.1161/CIRCULATIONAHA.111.055970. Epub 2012 Jan 3. Oldgren J, Alings M, Darius H, Diener HC, Eikelboom J, Ezekowitz MD, Kamensky G, Reilly PA, Yang S, Yusuf S, Wallentin L, Connolly SJ; RE-LY Investigators. Risks for stroke, bleeding, and death in patients with atrial fibrillation receiving dabigatran or warfarin in relation to the CHADS2 score: a subgroup analysis of the RE-LY trial. Ann Intern Med. 2011 Nov 15;155(10):660-7, W204. doi: 10.7326/0003-4819-155-10-201111150-00004. Eikelboom JW, Wallentin L, Connolly SJ, Ezekowitz M, Healey JS, Oldgren J, Yang S, Alings M, Kaatz S, Hohnloser SH, Diener HC, Franzosi MG, Huber K, Reilly P, Varrone J, Yusuf S. Risk of bleeding with 2 doses of dabigatran compared with warfarin in older and younger patients with atrial fibrillation: an analysis of the randomized evaluation of long-term anticoagulant therapy (RE-LY) trial. Circulation. 2011 May 31;123(21):2363-72. doi: 10.1161/CIRCULATIONAHA.110.004747. Epub 2011 May 16. Nagarakanti R, Ezekowitz MD, Oldgren J, Yang S, Chernick M, Aikens TH, Flaker G, Brugada J, Kamensky G, Parekh A, Reilly PA, Yusuf S, Connolly SJ. Dabigatran versus warfarin in patients with atrial fibrillation: an analysis of patients undergoing cardioversion. Circulation. 2011 Jan 18;123(2):131-6. doi: 10.1161/CIRCULATIONAHA.110.977546. Epub 2011 Jan 3. Ezekowitz MD, Wallentin L, Connolly SJ, Parekh A, Chernick MR, Pogue J, Aikens TH, Yang S, Reilly PA, Lip GY, Yusuf S; RE-LY Steering Committee and Investigators. Dabigatran and warfarin in vitamin K antagonist-naive and -experienced cohorts with atrial fibrillation. Circulation. 2010 Nov 30;122(22):2246-53. doi: 10.1161/CIRCULATIONAHA.110.973735. Diener HC, Connolly SJ, Ezekowitz MD, Wallentin L, Reilly PA, Yang S, Xavier D, Di Pasquale G, Yusuf S; RE-LY study group. Dabigatran compared with warfarin in patients with atrial fibrillation and previous transient ischaemic attack or stroke: a subgroup analysis of the RE-LY trial. Lancet Neurol. 2010 Dec;9(12):1157-1163. doi: 10.1016/S1474-4422(10)70274-X. Epub 2010 Nov 6. Erratum In: Lancet Neurol. 2011 Jan;10(1):27. Wallentin L, Yusuf S, Ezekowitz MD, Alings M, Flather M, Franzosi MG, Pais P, Dans A, Eikelboom J, Oldgren J, Pogue J, Reilly PA, Yang S, Connolly SJ; RE-LY investigators. Efficacy and safety of dabigatran compared with warfarin at different levels of international normalised ratio control for stroke prevention in atrial fibrillation: an analysis of the RE-LY trial. Lancet. 2010 Sep 18;376(9745):975-83. doi: 10.1016/S0140-6736(10)61194-4. Connolly SJ, Ezekowitz MD, Yusuf S, Eikelboom J, Oldgren J, Parekh A, Pogue J, Reilly PA, Themeles E, Varrone J, Wang S, Alings M, Xavier D, Zhu J, Diaz R, Lewis BS, Darius H, Diener HC, Joyner CD, Wallentin L; RE-LY Steering Committee and Investigators. Dabigatran versus warfarin in patients with atrial fibrillation. N Engl J Med. 2009 Sep 17;361(12):1139-51. doi: 10.1056/NEJMoa0905561. Epub 2009 Aug 30. Erratum In: N Engl J Med. 2010 Nov 4;363(19):1877. Ezekowitz MD, Connolly S, Parekh A, Reilly PA, Varrone J, Wang S, Oldgren J, Themeles E, Wallentin L, Yusuf S. Rationale and design of RE-LY: randomized evaluation of long-term anticoagulant therapy, warfarin, compared with dabigatran. Am Heart J. 2009 May;157(5):805-10, 810.e1-2. doi: 10.1016/j.ahj.2009.02.005.
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