Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate

This study has been completed.
Sponsor:
Collaborators:
Population Health Research Institute
Uppsala University
Information provided by:
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00262600
First received: December 6, 2005
Last updated: November 5, 2014
Last verified: April 2014
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
  Hide Participant Flow

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
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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
Total Total of all reporting groups

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
  Show All Outcome Measures

1.  Primary:   Yearly Event Rate for Composite Endpoint of Stroke/SEE   [ Time Frame: 36 months ]

2.  Secondary:   Yearly Event Rate for Composite Endpoint of Stroke/SEE/All Cause Death   [ Time Frame: 36 months ]

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

4.  Secondary:   Bleeding Events (Major and Minor)   [ Time Frame: 36 months ]

5.  Secondary:   Clinical Relevant Abnormalities for Intracerebral Hemorrhage and Other Intracranial Hemorrhage (ICH)   [ Time Frame: 36 months ]

6.  Secondary:   Abnormal Liver Function Test   [ Time Frame: 36 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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.


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

Publications automatically indexed to this study:


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: November 5, 2014
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, FAMHP
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada
China: 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 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