Conditions: Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2867
Healthy volunteers: no

Brief summary:
The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.

Detailed description:

Arms:
arm 1: Patient to receive 1 capsule containing dabigatran 150 mg twice daily plus placebo tablets for warfarin as decided by sham INR measurements arm 2: Patient to receive warfarin tablets to target INR 2.0-3.0 plus placebo capsules for dabigatran twice daily

Interventions: intervention 1: Dabigatran intervention 2: Warfarin
Intervention descriptions: intervention 1: Dabigatran 150 mg BID (twice daily) intervention 2: Warfarin dosed individually to maintain INR 2.0-3.0

Protocol document: