Phase III Study Testing Efficacy & Safety of Oral Dabigatran Etexilate vs Warfarin for 6 m Treatment for Acute Symp Venous Thromboembolism (VTE)
- Registration Number
- NCT00680186
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin Pro re nata (As needed/PRN) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic VTE.
The primary objective is to investigate the efficacy of dabigatran compared to warfarin during the 6 month treatment period. The investigation of other selected efficacy aspects and safety are regarded as secondary objective of this trial.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2589
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Warfarin (INR 2.0-3.0) Warfarin Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0 Dabigatran etexilate (150mg bid) Dabigatran etexilate Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily
- Primary Outcome Measures
Name Time Method Number of Participants With Recurrent Symptomatic Venous Thromboembolism (VTE) and Deaths Related to VTE 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) All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
- Secondary Outcome Measures
Name Time Method Number of Participants With Recurrent Symptomatic VTE and All Deaths 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. VTE or any death which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic DVT 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. Symptomatic DVT which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic Non-fatal PE 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. Symptomatic non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants Who Died Due to VTE From randomisation to 6 months (up to day 180) and to end of ptp (planned to be up to day 224) VTE - related deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee. Hazard ratios and 95% CI were not calculated because of insufficient number of events.
Number of Participants Who Died (Any Cause) 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. Any deaths which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With Recurrent Symptomatic Fatal and Non-fatal PE 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. Symptomatic fatal and non-fatal PE which occured from randomisation to end of ptp. All suspected recurrent VTEs and all deaths and bleeding events were evaluated by an independent central adjudication committee, and all analyses are based on the events that were centrally confirmed by this committee.
Number of Participants With MBE, MBE and/or CRBE, and Any Bleeding Events From first intake of study drug to last intake of study drug + 6 days washout Major bleeding events (MBE) are defined as
* Fatal bleeding
* Symptomatic bleeding in a critical area or organ
* Bleeding causing a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of 2 or more units of whole blood or red cells
Clinically-relevant bleeding events (CRBE) are defined as
* spontaneous skin hematoma \>=25 cm²
* wound hematoma \>=100 cm²
* spontaneous nose bleed \>5 min
* macroscopic hematuria spontaneous or \>24 hours if associated with an intervention
* spontaneous rectal bleeding
* gingival bleeding \>5 min
* leading to hospitalisation and / or requiring surgical treatment
* leading to a transfusion of \<2 units of whole blood or red cells
* any other bleeding event considered clinically relevant by the investigator
Any bleeding events were defined as major, clinically-relevant and nuisance bleeding events. Nuisance bleeding events were defined as all other bleeding events that did not fulfil the criteria from above.Number of Participants With Acute Coronary Syndrome (ACS) From first intake of study drug to last contact date Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Patients having a centrally adjudicated definite ACS during intake of study drug and after stopping study drug, according to treatment group. ACS assessments pre-specified in the protocol without adjudication. Prior to database lock, the steering committee asked to have ACS events adjudicated by an independent committee. After database lock, the committee was provided with source documentation that was blinded to the patient's treatment assignment. ACS results presented are based on adjudication findings.
Laboratory Analyses From first intake of study drug to last intake of study drug + 6 days washout Frequency of patients with possible clinically significant abnormalities.
Trial Locations
- Locations (220)
1160.46.01073 Boehringer Ingelheim Investigational Site
🇺🇸Little Rock, Arkansas, United States
1160.46.01044 Boehringer Ingelheim Investigational Site
🇺🇸Clearwater, Florida, United States
1160.46.01068 Boehringer Ingelheim Investigational Site
🇺🇸Normal, Illinois, United States
1160.46.01071 Boehringer Ingelheim Investigational Site
🇺🇸Shreveport, Louisiana, United States
1160.46.01060 Boehringer Ingelheim Investigational Site
🇺🇸Stony Brook, New York, United States
1160.46.01061 Boehringer Ingelheim Investigational Site
🇺🇸Columbus, Ohio, United States
1160.46.01059 Boehringer Ingelheim Investigational Site
🇺🇸Bend, Oregon, United States
1160.46.01063 Boehringer Ingelheim Investigational Site
🇺🇸Corvallis, Oregon, United States
1160.46.01055 Boehringer Ingelheim Investigational Site
🇺🇸Summerville, South Carolina, United States
1160.46.01062 Boehringer Ingelheim Investigational Site
🇺🇸Bellevue, Washington, United States
Scroll for more (210 remaining)1160.46.01073 Boehringer Ingelheim Investigational Site🇺🇸Little Rock, Arkansas, United States