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Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
This study has been completed.
Study NCT00262600   Information provided by Boehringer Ingelheim Pharmaceuticals

First Received on December 6, 2005.   Last Updated on July 4, 2011   History of Changes
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Primary Purpose: Prevention
Conditions: Atrial Fibrillation
Stroke
Interventions: Drug: warfarin
Drug: Dabigatran dose 1
Drug: Dabigatran dose 2

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Dabigatran 110 mg 110 mg twice daily, total daily dose 220 mg
Dabigatran 150 mg 150 mg twice daily, total daily dose 300 mg
Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0

Participant Flow:   Overall Study
    Dabigatran 110 mg     Dabigatran 150 mg     Warfarin  
STARTED     6015     6076     6022  
COMPLETED     5780     5824     5756  
NOT COMPLETED     235     252     266  
Lost to Follow-up                 17                 31                 41  
Withdrawal by Subject                 128                 145                 139  
Not Treated                 32                 17                 24  
Not Specified                 58                 59                 62  



  Baseline Characteristics
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Reporting Groups
  Description
Dabigatran 110 mg 110 mg twice daily, total daily dose 220 mg
Dabigatran 150 mg 150 mg twice daily, total daily dose 300 mg
Warfarin Target International Normalized Ratio (INR) of 2.0 to 3.0

Baseline Measures
    Dabigatran 110 mg     Dabigatran 150 mg     Warfarin     Total  
Number of Participants  
[units: participants]
 		  6015     6076     6022     18113  
Age  
[units: years]
Mean ± Standard Deviation 		  71.4  ± 8.6     71.5  ± 8.8     71.6  ± 8.6     71.5  ± 8.7  
Age, Customized  
[units: Participants]
 		       
<65     998     1030     953     2981  
65<= and <75     2668     2580     2646     7894  
>=75     2349     2466     2423     7238  
Gender, Customized  
[units: participants]
 		       
Male     3865     3840     3809     11514  
Female     2149     2236     2213     6598  
Missing     1     0     0     1  
Ethnicity (NIH/OMB)  
[units: participants]
 		       
Not Hispanic or Latino     5593     5660     5615     16868  
Hispanic or Latino     421     416     407     1244  
Unknown or Not Reported     1     0     0     1  
Race/Ethnicity, Customized  
[units: participants]
 		       
White     4208     4268     4203     12679  
Black     52     57     67     176  
Asian     955     965     955     2875  
Other     799     786     797     2382  
Missing     1     0     0     1  
Region of Enrollment  
[units: participants]
 		       
USA, Canada     2166     2200     2167     6533  
Central Europe     707     706     706     2119  
Western Europe     1544     1555     1552     4651  
Latin America     320     320     316     956  
Asia     923     933     926     2782  
Other     355     362     355     1072  
Smoking history  
[units: participants]
 		       
Non-smoker     2941     2993     3006     8940  
Smoker     440     447     448     1335  
Ex-smoker     2633     2636     2567     7836  
Missing     1     0     1     2  
Regular Alcohol Consumption  
[units: participants]
 		       
No     4017     4077     4040     12134  
Yes     1996     1999     1981     5976  
Missing     2     0     1     3  



  Outcome Measures
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1.  Primary:   Yearly Event Rate for Composite Endpoint of Stroke/SEE   [ Time Frame: 36 months ]
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2.  Secondary:   Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death   [ Time Frame: 36 months ]
  Show Outcome Measure 2

3.  Secondary:   Yearly Event Rate: Composite of Stroke/SEE/PE/MI/Vascular Death   [ Time Frame: 36 months ]
  Show Outcome Measure 3


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com


No publications provided by Boehringer Ingelheim Pharmaceuticals

Publications automatically indexed to this study:
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.
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. 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. 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.
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):1157-63. Epub 2010 Nov 6.
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. Epub 2009 Aug 30.
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.


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00262600     History of Changes
Other Study ID Numbers: 1160.26, 2005-003894-26
Study First Received: December 6, 2005
Results First Received: November 18, 2010
Last Updated: July 4, 2011
Health Authority: Argentina: A.N.M.A.T. (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica);   Australia: Responsilble Ethics Committee;   Austria: Federal Office for Safety in Health Care;   Belgium: Federal Agency for Medicines and Health Products;   Brazil: National Health Surveillance Agency;   Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia;   Canada: Health Canada;   China: State Food and Drug Administration;   Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos;   Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10;   Denmark: Danish Medicines Agency;   Finland: Finnish Medicines Agency;   France: AFFSAPS;   Germany: Federal Institute for Drugs and Medical Devices;   Great Britain: MHRA;   Greece: National Organization for Medicines (EOF) National Ethics Committee;   Hong Kong: Department of Health;   Hungary: National Institute of Pharmacy, H-1051 Budapest;   India: Drug Control General of India;   Israel: Ministry of Health;   Italy: Comitato Etico Indipendente - BOLOGNA;   Japan: Ministry of Health, Labor and Welfare;   Korea, Republic of: KOREA Food and Drug Administration (KFDA);   Malaysia: Drug Control Authority;   Mexico: Federal Commission for Sanitary Risks Protection;   Netherlands: The Central Committee on Research Involving Human Subjects (CCMO);   Norway: Norwegian Medicines Agency (Statens Legemiddelverk);   Peru: General Directorate of Pharmaceuticals, Devices, and Drugs;   Philippines: Bureau of Food and Drug;   Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products;   Portugal: INFARMED - National Authority of Medicines and Health Products, IP;   Romania: National Medicines Agency, Bucharest;   Russia: Ministry of Health and Social Development of the Russian Federation;   Singapore: Health Sciences Authority;   Slovakia: SUKL (state institute for drug control), SK-825 08 Bratislava 26;   South Africa: MCC;   Spain: Agencia Española del Medicamento y Productos Sanitarios;   Sweden: Medical Products Agency;   Switzerland: Swissmedic;   Taiwan: Department of Health, Executive Yuan, Taiwan;   Thailand: Thai Food & Drug Administration;   Turkey: Ministry of Health Central Ethics Committee;   Ukraine: Ministry of Health Care of Ukraine (MoH of Ukraine);   United States: Food and Drug Administration





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