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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
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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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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 
Overall Participants Analyzed 
[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 ]

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
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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
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00262600     History of Changes
Other Study ID Numbers: 1160.26
2005-003894-26 ( EudraCT Number: EudraCT )
Study First Received: December 6, 2005
Results First Received: November 18, 2010
Last Updated: November 5, 2014
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