Twice-daily Oral Direct Thrombin Inhibitor Dabigatran Etexilate in the Long Term Prevention of Recurrent Symptomatic VTE (RE-SONATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT00558259
First received: November 13, 2007
Last updated: June 17, 2014
Last verified: February 2014
Results First Received: January 31, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double-Blind;   Primary Purpose: Prevention
Condition: Venous Thromboembolism
Interventions: Drug: dabigatran etexilate 150 mg twice daily (BID)
Drug: matching placebo twice daily (BID)

  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
There were 3 patients randomised to placebo who received Dabigatran only. For all analyses of efficacy, these patients are analysed as randomised. For all analyses of safety, these patients are analysed as treated.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid (twice daily)
Placebo Matching placebo

Participant Flow:   Overall Study
    Dabigatran     Placebo  
STARTED     681 [1]   662 [2]
COMPLETED     610 [3]   563 [3]
NOT COMPLETED     71     99  
Adverse Event                 50                 81  
Protocol Violation                 9                 5  
Withdrawal by Subject                 12                 13  
[1] Number who started treatment. There were 4 patients randomised to Dabigatran and not treated.
[2] Number who started treatment. There were 6 patients randomised to placebo and not treated.
[3] Completed treatment.



  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 Dabigatran 150mg bid
Placebo Matching placebo
Total Total of all reporting groups

Baseline Measures
    Dabigatran     Placebo     Total  
Number of Participants  
[units: participants]
  681     662     1343  
Age  
[units: Years]
Mean ± Standard Deviation
  56.1  ± 15.5     55.5  ± 15.1     55.8  ± 15.3  
Gender  
[units: Participants]
     
Female     300     298     598  
Male     381     364     745  
Body mass index (BMI) continuous  
[units: kg/m^2]
Mean ± Standard Deviation
  28.45  ± 5.44     28.41  ± 5.56     28.43  ± 5.50  



  Outcome Measures
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1.  Primary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Including Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]

2.  Secondary:   Centrally Confirmed Symptomatic Recurrent Venous Thrombotic Events (VTE) Excluding Unexplained Death During the Intended Treatment Period   [ Time Frame: 6 months ]

3.  Secondary:   Centrally Confirmed Symptomatic Recurrent Deep Venous Thrombotic (DVT) Events During the Intended Treatment Period   [ Time Frame: 6 months ]

4.  Secondary:   Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period   [ Time Frame: 6 months ]

5.  Secondary:   Centrally Confirmed Unexplained Deaths During the Intended Treatment Period   [ Time Frame: 6 months ]

6.  Secondary:   Centrally Confirmed Bleeding Event During the Treatment Period   [ Time Frame: 6 months ]

7.  Secondary:   Centrally Confirmed Cardiovascular Events During the Treatment Period   [ Time Frame: 6 months ]

8.  Secondary:   Laboratory Measures, Especially Liver Function Tests (LFTs)   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame 6 months
Additional Description There were 3 patients who were randomised to placebo but who were treated with dabigatran only.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid
Placebo Matching placebo

Other Adverse Events
    Dabigatran     Placebo  
Total, other (not including serious) adverse events      
# participants affected / at risk     0/684     0/659  



  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
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