Efficacy and Safety of Dabigatran Compared to Warfarin for 6 Month Treatment of Acute Symptomatic Venous Thromboembolism

Phase 3

Completed

Conditions: Thromboembolism

Interventions: Drug: dabigatran etexilate 150 mg
Drug: warfarin (INR 2-3)

Registration Number: NCT00291330

Lead Sponsor: Boehringer Ingelheim

Brief Summary: The purpose of this trial is to determine the comparative safety and efficacy of dabigatran etexilate 150 mg bid administered orally and warfarin as needed (pro re nata - prn) to maintain an International Normalised Ratio (INR) of 2.0-3.0 for 6 month treatment of acute symptomatic venous thromboembolism (VTE), following initial treatment (5-10 days) with a parenteral anticoagulant approved for this indication. This trial aims to demonstrate non-inferiority of dabigatran compared with warfarin in patients with acute symptomatic VTE. After achieving non-inferiority, this trial also aims to establish superiority (by means of hierarchical tests) of dabigatran over warfarin.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2564

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
dabigatran etexilate 150 mg	dabigatran etexilate 150 mg	twice daily
warfarin (INR 2-3)	warfarin (INR 2-3)	prn to maintain INR (2-3)

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 post treatment period. 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 post treatment period. 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 (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 post treatment period. 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.
Laboratory Analyses	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)	Frequency of patients with possible clinically significant abnormalities.
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 post treatment period. 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 Bleeding Events	From first intake of study drug to last intake of study drug + 6 days washout (washout time can be reduced until 0 day if the patient takes an other anti-coagulant therapy on and after last intake of active study drug)	Major bleeding events (MBE) were 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) was defined as * spontaneous skin hematoma \>=25 cm² * spontaneous nose bleed \>5 min * macroscopic hematuria spontaneous or \>24 hours if associated with an intervention * spontaneous rectal bleeding (more than spotting on toilet paper) * 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 Who Died Due to VTE	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 - related deaths which occured from randomisation to end of post treatment period. 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 Acute Coronary Syndrome (ACS)	From first intake of study drug to end of study conduct	Any ACS occurring during the conduct of the study (centrally adjudicated as definite). Counts of patients having a centrally adjudicated definite ACS during intake of active study drug, after stopping active study drug and before or without intake of active study drug, according to treatment group. 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.

Trial Locations

Locations (250): 1160.53.01035 Boehringer Ingelheim Investigational Site
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Mobile, Alabama, United States
1160.53.01056 Boehringer Ingelheim Investigational Site
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Hartford, Connecticut, United States
1160.53.01044 Boehringer Ingelheim Investigational Site
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Clearwater, Florida, United States
1160.53.01033 Boehringer Ingelheim Investigational Site
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Sarasota, Florida, United States
1160.53.01046 Boehringer Ingelheim Investigational Site
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Sarasota, Florida, United States
1160.53.01019 Boehringer Ingelheim Investigational Site
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Augusta, Georgia, United States
1160.53.01008 Boehringer Ingelheim Investigational Site
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Decatur, Georgia, United States
1160.53.01010 Boehringer Ingelheim Investigational Site
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Marietta, Georgia, United States
1160.53.01014 Boehringer Ingelheim Investigational Site
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Baltimore, Maryland, United States
1160.53.01023 Boehringer Ingelheim Investigational Site
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Detroit, Michigan, United States
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1160.53.01035 Boehringer Ingelheim Investigational Site
🇺🇸Mobile, Alabama, United States