Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE) (RE-COVER II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00680186
First received: May 16, 2008
Last updated: December 10, 2013
Last verified: December 2013
Results First Received: May 4, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Treatment
Condition: Thromboembolism
Interventions: Drug: Warfarin
Drug: Dabigatran etexilate

  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
There were 2589 patients enrolled/randomised but only 2568 were treated.

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 150 mg bid (twice daily) oral
Warfarin PRN (as needed) to maintain an INR (international normalised ratio) of 2.0-3.0

Participant Flow:   Overall Study
    Dabigatran 150 mg     Warfarin  
STARTED     1280 [1]   1288 [1]
COMPLETED     1155 [2]   1172 [2]
NOT COMPLETED     125     116  
Adverse Event                 47                 44  
Protocol Violation                 31                 26  
Lost to Follow-up                 11                 6  
Withdrawal by Subject                 32                 39  
Unknown                 4                 1  
[1] Started treatment.
[2] Completed planned observation time.



  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 150 mg bid oral
Warfarin PRN to maintain an INR of 2.0-3.0
Total Total of all reporting groups

Baseline Measures
    Dabigatran 150 mg     Warfarin     Total  
Number of Participants  
[units: participants]
  1280     1288     2568  
Age  
[units: Years]
Mean ± Standard Deviation
  54.7  ± 16.19     55.1  ± 16.26     54.9  ± 16.22  
Gender  
[units: participants]
     
Female     499     512     1011  
Male     781     776     1557  
Investigator assessed acute symptomatic deep vein thrombosis (DVT) of leg or pulmonary embolism (PE)  
[units: participants]
     
Symptomatic PE and symptomatic DVT     104     117     221  
Symptomatic PE     298     297     595  
Symptomatic DVT     877     873     1750  
No PE and no DVT     1     1     2  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE   [ Time Frame: For statistical analysis 1: from randomisation to end of post treatment period (ptp), planned to be up to day 224. For statistical analysis 2: from randomisation to 6 months (up to day 180) ]

2.  Secondary:   Number of Participants With Recurrent Symptomatic VTE and All Deaths   [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

3.  Secondary:   Number of Participants With Recurrent Symptomatic DVT   [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

4.  Secondary:   Number of Participants With Recurrent Symptomatic Non-fatal PE   [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

5.  Secondary:   Number of Participants Who Died Due to VTE   [ Time Frame: From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) ]

6.  Secondary:   Number of Participants Who Died (Any Cause)   [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180) For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

7.  Secondary:   Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE   [ Time Frame: For statistical analysis 1: from randomisation to 6 months (up to day 180). For statistical analysis 2: from randomisation to end of ptp, planned to be up to day 224. ]

8.  Secondary:   Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events   [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout ]

9.  Secondary:   Number of Participants With Acute Coronary Syndrome (ACS)   [ Time Frame: From first intake of study drug to last contact date ]

10.  Secondary:   Laboratory Analyses   [ Time Frame: From first intake of study drug to last intake of study drug + 6 days washout ]


  Serious Adverse Events


  Other Adverse Events


  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

Publications automatically indexed to this study:

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00680186     History of Changes
Other Study ID Numbers: 1160.46, 2007-002631-86
Study First Received: May 16, 2008
Results First Received: May 4, 2012
Last Updated: December 10, 2013
Health Authority: Australia: Dept of Health and Ageing Therapeutic Goods Admin
Brazil: National Health Surveillance Agency
Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia
Canada: Health Canada, Therapeutic Products Directorate
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Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10
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Great Britain: MHRA
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Malaysia: National Pharmaceutical Control Bureau
Netherlands: Central Committee Research Involving Human Subjects
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