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 ]
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Measure Type Secondary
Measure Title Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Measure Description Number of participants with centrally confirmed symptomatic pulmonary embolism (PE) events during the intended treatment period were described.
Time Frame 6 months  
Safety Issue No  

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.
FAS and analysed as randomised.

Reporting Groups
  Description
Dabigatran Dabigatran 150mg bid
Placebo Matching placebo

Measured Values
    Dabigatran     Placebo  
Number of Participants Analyzed  
[units: participants]
  681     662  
Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period  
[units: Participants]
  1     14  


Statistical Analysis 1 for Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.0004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Dabigatran vs. Placebo
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Groups [1] Dabigatran
Percentage of participants with events [2] 0.1
95% Confidence Interval ( 0.00 to 0.82 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in Dabigatran group.

Statistical Analysis 3 for Centrally Confirmed Symptomatic Pulmonary Embolism (PE) Events During the Intended Treatment Period
Groups [1] Placebo
Percentage of participants with events [2] 2.1
95% Confidence Interval ( 1.16 to 3.52 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant estimation information:
  The confidence interval (Clopper-Pearson method) was calculated for the percentage of participants experiencing PE in placebo group.



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


  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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