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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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)
Secondary ID [1] 0 0
2005-003894-26
Secondary ID [2] 0 0
1160.26
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Stroke 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE
Timepoint [1] 0 0
36 months
Secondary outcome [1] 0 0
Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death
Timepoint [1] 0 0
36 months
Secondary outcome [2] 0 0
Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death
Timepoint [2] 0 0
36 months
Secondary outcome [3] 0 0
Bleeding Events (Major and Minor)
Timepoint [3] 0 0
36 months
Secondary outcome [4] 0 0
Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)
Timepoint [4] 0 0
36 months
Secondary outcome [5] 0 0
Abnormal Liver Function Test
Timepoint [5] 0 0
36 months

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
18113
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC
Recruitment hospital [1] 0 0
1160.26.0508 Boehringer Ingelheim Investigational Site - Coffs Harbour
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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
Recruitment hospital [6] 0 0
1160.26.0507 Boehringer Ingelheim Investigational Site - Launceston
Recruitment hospital [7] 0 0
1160.26.0504 Boehringer Ingelheim Investigational Site - Box Hill
Recruitment hospital [8] 0 0
1160.26.0501 Boehringer Ingelheim Investigational Site - Geelong
Recruitment hospital [9] 0 0
1160.26.0502 Boehringer Ingelheim Investigational Site - Parkville
Recruitment hospital [10] 0 0
1160.26.0503 Boehringer Ingelheim Investigational Site - Prahran
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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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- Prahran
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Kharkov
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Kiev
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Lvov
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State/province [419] 0 0
Birmingham
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United Kingdom
State/province [420] 0 0
Chertsey
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United Kingdom
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Glasgow
Country [422] 0 0
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Harrow
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Hull
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Kirkcaldy, Fife
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Londonderry
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London
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Newcastle upon Tyne
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Newport
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United Kingdom
State/province [429] 0 0
Northampton
Country [430] 0 0
United Kingdom
State/province [430] 0 0
Portadown, County Atrim
Country [431] 0 0
United Kingdom
State/province [431] 0 0
Romford, Essex
Country [432] 0 0
United Kingdom
State/province [432] 0 0
Stoke-On-Trent
Country [433] 0 0
United Kingdom
State/province [433] 0 0
York

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Boehringer Ingelheim
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Population Health Research Institute
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Uppsala University
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00262600
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Boehringer Ingelheim
Address 0 0
Boehringer Ingelheim
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00262600