Conditions: Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2564
Healthy volunteers: no

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:

Arms:
arm 1: twice daily arm 2: prn to maintain INR (2-3)

Interventions: intervention 1: dabigatran etexilate 150 mg intervention 2: warfarin (INR 2-3)
Intervention descriptions: intervention 1: twice daily intervention 2: prn to maintain INR (2-3)

Protocol document: