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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02164864




Registration number
NCT02164864
Ethics application status
Date submitted
13/06/2014
Date registered
17/06/2014
Date last updated
31/07/2018

Titles & IDs
Public title
Evaluation of Dual Therapy With Dabigatran vs. Triple Therapy With Warfarin in Patients With AF That Undergo a PCI With Stenting (REDUAL-PCI)
Scientific title
A Prospective Randomised, Open Label, Blinded Endpoint (PROBE) Study to Evaluate DUAL Antithrombotic Therapy With Dabigatran Etexilate (110mg and 150mg b.i.d.) Plus Clopidogrel or Ticagrelor vs. Triple Therapy Strategy With Warfarin (INR 2.0 - 3.0) Plus Clopidogrel or Ticagrelor and Aspirin in Patients With Non Valvular Atrial Fibrillation (NVAF) That Have Undergone a Percutaneous Coronary Intervention (PCI) With Stenting
Secondary ID [1] 0 0
2013-003201-26
Secondary ID [2] 0 0
1160.186
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Fibrillation 0 0
Percutaneous Coronary Intervention 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 - Dabigatran Etexilate 110mg
Treatment: Drugs - Warfarin 3mg
Treatment: Drugs - Aspirin
Treatment: Drugs - Dabigatran Etexilate 150mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 5mg
Treatment: Drugs - Clopidogrel or Ticagrelor
Treatment: Drugs - Warfarin 1mg

Experimental: Dabigatran Etexilate 110mg - Patient to receive Dabigatran Etexilate 110mg twice a day (BID)

Experimental: Dabigatran Etexilate 150mg - Patient to receive Dabigatran Etexilate 150mg twice a day (BID)

Active comparator: Warfarin - Warfarin doses to maintain INR


Treatment: Drugs: Dabigatran Etexilate 110mg
Active treatment

Treatment: Drugs: Warfarin 3mg
Active comparator

Treatment: Drugs: Aspirin
Active comparator

Treatment: Drugs: Dabigatran Etexilate 150mg
Active treatment

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Warfarin 5mg
Active comparator

Treatment: Drugs: Clopidogrel or Ticagrelor
Active comparator

Treatment: Drugs: Warfarin 1mg
Active comparator
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Time to First Adjudicated ISTH MBE or CRNMBE
Timepoint [1] 0 0
up to 30 months
Secondary outcome [1] 0 0
Time to Adjudicated Undetermined Cause of Death
Timepoint [1] 0 0
up to 30 months
Secondary outcome [2] 0 0
Time to Adjudicated Non-CV
Timepoint [2] 0 0
up to 30 months
Secondary outcome [3] 0 0
Time to Adjudicated CV
Timepoint [3] 0 0
up to 30 months
Secondary outcome [4] 0 0
Time to Adjudicated All Cause Death
Timepoint [4] 0 0
up to 30 months
Secondary outcome [5] 0 0
Time to First Adjudicated MI
Timepoint [5] 0 0
up to 30 months
Secondary outcome [6] 0 0
Time to First Adjudicated Stroke
Timepoint [6] 0 0
up to 30 months
Secondary outcome [7] 0 0
Time to First Adjudicated SE
Timepoint [7] 0 0
up to 30 months
Secondary outcome [8] 0 0
Time to First Adjudicated ST
Timepoint [8] 0 0
up to 30 months
Secondary outcome [9] 0 0
Time to Composite Endpoint of Death + MI + Stroke
Timepoint [9] 0 0
up to 30 months
Secondary outcome [10] 0 0
Time to Composite Endpoint of Death or First Thrombotic Event
Timepoint [10] 0 0
up to 30 months
Secondary outcome [11] 0 0
Time to First Adjudicated Unplanned Revascularisation by PCI/CABG
Timepoint [11] 0 0
up to 30 months
Secondary outcome [12] 0 0
Time to Death or First Thrombotic Event or Unplanned Revascularisation by PCI/CABG
Timepoint [12] 0 0
up to 30 months

Eligibility
Key inclusion criteria
Inclusion criteria:

* Male or female patients aged >=18 years
* Patients with Non Valvular Atrial Fibrillation
* Patient presenting with:

An Acute Coronary Syndrome (ACS) (ST elevation myocardial infarction (STEMI), NonSTEMI [NSTEMI] or unstable angina [UA]) that was successfully treated by PCI and stenting (either Bare Metal Stent (BMS) or Drug Eluting Stent) Or Stable Coronary Artery Disease with at least one lesion eligible for PCI that was successfully treated by elective PCI and stenting (either BMS or DES)

* The patient must be able to give informed consent in accordance with International Conference on Harmonisation Good Clinical Practice guidelines and local legislation and/or regulations.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria:

* Patients with a mechanical or biological heart valve prosthesis
* Cardiogenic shock during current hospitalisation
* Stroke within 1 month prior to screening visit
* Patients who have had major surgery within the month prior to screening
* Gastrointestinal haemorrhage within one month prior to screening, unless, in the opinion of the Investigator, the cause has been permanently eliminated
* Major bleeding episode including life-threatening bleeding episode in one month prior to screening visit
* Anaemia (haemoglobin <10g/dL) or thrombocytopenia including heparin-induced thrombocytopenia (platelet count <100 x 109/L) at screening
* Severe renal impairment (estimated Creatinine Clearance (CrCl) calculated by Cockcroft-Gault equation) <30mL/min at screening
* Active liver disease

Study design
Purpose of the study
Treatment
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
Open (masking not 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
22/07/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
5/06/2017
Sample size
Target
Accrual to date
Final
2725
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Pendlebury Research - Adamstown
Recruitment hospital [2] 0 0
Gosford Hospital - Gosford
Recruitment hospital [3] 0 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [4] 0 0
Wollongong Hospital - Wollongong
Recruitment hospital [5] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
Heartcare Victoria - Bundoora
Recruitment hospital [8] 0 0
The Geelong Hospital - Geelong
Recruitment postcode(s) [1] 0 0
2289 - Adamstown
Recruitment postcode(s) [2] 0 0
2250 - Gosford
Recruitment postcode(s) [3] 0 0
2065 - St Leonards
Recruitment postcode(s) [4] 0 0
2500 - Wollongong
Recruitment postcode(s) [5] 0 0
4032 - Chermside
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
3083 - Bundoora
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment outside Australia
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Patras
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Fukuoka, Koga
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Fukuoka, Kurume
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Gunma, Maebashi
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Gunma, Takasaki
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Kagawa, Takamatsu
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Kanagawa, Fujisawa
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Kanagawa, Sagamihara
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Kanagawa, Yokohama
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Kyoto, Kyoto
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Miyazaki, Miyazaki
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Japan
State/province [203] 0 0
Osaka, Osaka
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Japan
State/province [204] 0 0
Saitama, Sayama
Country [205] 0 0
Japan
State/province [205] 0 0
Saitama, Wako
Country [206] 0 0
Japan
State/province [206] 0 0
Shiga, Kusatsu
Country [207] 0 0
Japan
State/province [207] 0 0
Shiga, Omihachiman
Country [208] 0 0
Japan
State/province [208] 0 0
Tokushima, Komatsushima
Country [209] 0 0
Japan
State/province [209] 0 0
Tokyo, Adachi-ku
Country [210] 0 0
Japan
State/province [210] 0 0
Tokyo, Bunkyo-ku
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Japan
State/province [211] 0 0
Tokyo, Hachioji
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Japan
State/province [212] 0 0
Tokyo, Itabashi-Ku
Country [213] 0 0
Japan
State/province [213] 0 0
Tokyo, Shinjuku-ku
Country [214] 0 0
Korea, Republic of
State/province [214] 0 0
Busan
Country [215] 0 0
Korea, Republic of
State/province [215] 0 0
Daegu
Country [216] 0 0
Korea, Republic of
State/province [216] 0 0
Gwangju
Country [217] 0 0
Korea, Republic of
State/province [217] 0 0
Pusan
Country [218] 0 0
Korea, Republic of
State/province [218] 0 0
Seoul
Country [219] 0 0
Korea, Republic of
State/province [219] 0 0
Suncheon
Country [220] 0 0
Korea, Republic of
State/province [220] 0 0
Suwon
Country [221] 0 0
Korea, Republic of
State/province [221] 0 0
Wonju
Country [222] 0 0
Mexico
State/province [222] 0 0
Aguascalientes
Country [223] 0 0
Mexico
State/province [223] 0 0
Ciudad de Mexico
Country [224] 0 0
Mexico
State/province [224] 0 0
San Luis Potosi
Country [225] 0 0
Mexico
State/province [225] 0 0
Zapopan, Jalisco
Country [226] 0 0
Netherlands
State/province [226] 0 0
Alkmaar
Country [227] 0 0
Netherlands
State/province [227] 0 0
Eindhoven
Country [228] 0 0
Netherlands
State/province [228] 0 0
Emmen
Country [229] 0 0
Netherlands
State/province [229] 0 0
Goes
Country [230] 0 0
Netherlands
State/province [230] 0 0
Groningen
Country [231] 0 0
Netherlands
State/province [231] 0 0
Nieuwegein
Country [232] 0 0
Netherlands
State/province [232] 0 0
Nijmegen
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Netherlands
State/province [233] 0 0
Uden
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New Zealand
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Hamilton
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Norway
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Arendal
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Norway
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Oslo
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Norway
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Stavanger
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Norway
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Tromsø
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Gdansk
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Poland
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Kielce
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Poland
State/province [243] 0 0
Lublin
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Poland
State/province [244] 0 0
Pulawy
Country [245] 0 0
Poland
State/province [245] 0 0
Warsaw
Country [246] 0 0
Poland
State/province [246] 0 0
Wroclaw
Country [247] 0 0
Poland
State/province [247] 0 0
Zamosc
Country [248] 0 0
Portugal
State/province [248] 0 0
Almada
Country [249] 0 0
Portugal
State/province [249] 0 0
Coimbra
Country [250] 0 0
Portugal
State/province [250] 0 0
Leiria
Country [251] 0 0
Portugal
State/province [251] 0 0
Lisboa
Country [252] 0 0
Portugal
State/province [252] 0 0
S. Martinho Do Bispo,Coimbra
Country [253] 0 0
Russian Federation
State/province [253] 0 0
Barnaul
Country [254] 0 0
Russian Federation
State/province [254] 0 0
Chelyabinsk
Country [255] 0 0
Russian Federation
State/province [255] 0 0
Ekaterinburg
Country [256] 0 0
Russian Federation
State/province [256] 0 0
Kazan
Country [257] 0 0
Russian Federation
State/province [257] 0 0
Kemerovo
Country [258] 0 0
Russian Federation
State/province [258] 0 0
Krasnodar
Country [259] 0 0
Russian Federation
State/province [259] 0 0
Moscow
Country [260] 0 0
Russian Federation
State/province [260] 0 0
Saint Petersburg
Country [261] 0 0
Russian Federation
State/province [261] 0 0
Samara
Country [262] 0 0
Russian Federation
State/province [262] 0 0
St.Petersburg
Country [263] 0 0
Russian Federation
State/province [263] 0 0
Volgograd
Country [264] 0 0
Singapore
State/province [264] 0 0
Singapore
Country [265] 0 0
Slovakia
State/province [265] 0 0
Banska Bystrica
Country [266] 0 0
Slovakia
State/province [266] 0 0
Bratislava
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Slovakia
State/province [267] 0 0
Kosice
Country [268] 0 0
Slovakia
State/province [268] 0 0
Nitra
Country [269] 0 0
Slovenia
State/province [269] 0 0
Celje
Country [270] 0 0
Slovenia
State/province [270] 0 0
Izola
Country [271] 0 0
Slovenia
State/province [271] 0 0
Ljubljana
Country [272] 0 0
Slovenia
State/province [272] 0 0
Maribor
Country [273] 0 0
Spain
State/province [273] 0 0
Barcelona
Country [274] 0 0
Spain
State/province [274] 0 0
L'Hospitalet Llobregat (bcn)
Country [275] 0 0
Spain
State/province [275] 0 0
Madrid
Country [276] 0 0
Spain
State/province [276] 0 0
Malaga
Country [277] 0 0
Spain
State/province [277] 0 0
Manises
Country [278] 0 0
Spain
State/province [278] 0 0
Sabadell (Barcelona)
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Spain
State/province [279] 0 0
Santiago de Compostela
Country [280] 0 0
Spain
State/province [280] 0 0
Sevilla
Country [281] 0 0
Spain
State/province [281] 0 0
Vizcaya
Country [282] 0 0
Spain
State/province [282] 0 0
Zaragoza
Country [283] 0 0
Sweden
State/province [283] 0 0
Gävle
Country [284] 0 0
Sweden
State/province [284] 0 0
Göteborg
Country [285] 0 0
Sweden
State/province [285] 0 0
Halmstad
Country [286] 0 0
Sweden
State/province [286] 0 0
Helsingborg
Country [287] 0 0
Sweden
State/province [287] 0 0
Linköping
Country [288] 0 0
Sweden
State/province [288] 0 0
Lund
Country [289] 0 0
Sweden
State/province [289] 0 0
Malmö
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Sweden
State/province [290] 0 0
Stockholm
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Taiwan
State/province [291] 0 0
Changhua
Country [292] 0 0
Taiwan
State/province [292] 0 0
Kaohsiung
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Taiwan
State/province [293] 0 0
Taichung
Country [294] 0 0
Taiwan
State/province [294] 0 0
Tainan
Country [295] 0 0
Taiwan
State/province [295] 0 0
Taipei
Country [296] 0 0
Taiwan
State/province [296] 0 0
Taoyuan
Country [297] 0 0
Thailand
State/province [297] 0 0
Bangkok
Country [298] 0 0
Thailand
State/province [298] 0 0
Chiang Mai
Country [299] 0 0
Thailand
State/province [299] 0 0
Khon Kaen
Country [300] 0 0
Turkey
State/province [300] 0 0
Adana
Country [301] 0 0
Turkey
State/province [301] 0 0
Ankara
Country [302] 0 0
Turkey
State/province [302] 0 0
Bursa
Country [303] 0 0
Turkey
State/province [303] 0 0
Istanbul
Country [304] 0 0
Turkey
State/province [304] 0 0
Izmir
Country [305] 0 0
Turkey
State/province [305] 0 0
Kayseri
Country [306] 0 0
Turkey
State/province [306] 0 0
Samsun
Country [307] 0 0
United Kingdom
State/province [307] 0 0
Birmingham
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United Kingdom
State/province [308] 0 0
Bournemouth
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United Kingdom
State/province [309] 0 0
Derby
Country [310] 0 0
United Kingdom
State/province [310] 0 0
Dorchester
Country [311] 0 0
United Kingdom
State/province [311] 0 0
Grantham
Country [312] 0 0
United Kingdom
State/province [312] 0 0
High Wycombe
Country [313] 0 0
United Kingdom
State/province [313] 0 0
Leicester
Country [314] 0 0
United Kingdom
State/province [314] 0 0
Lincoln
Country [315] 0 0
United Kingdom
State/province [315] 0 0
Londonderry
Country [316] 0 0
United Kingdom
State/province [316] 0 0
London
Country [317] 0 0
United Kingdom
State/province [317] 0 0
Middlesbrough
Country [318] 0 0
United Kingdom
State/province [318] 0 0
Stoke-on-Trent

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Boehringer Ingelheim
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT02164864