Conditions: Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2589
Healthy volunteers: no

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:

Arms:
arm 1: Patients will receive 1 capsule containing 150 mg dabigatran etexilate/matching placebo twice daily arm 2: Patients will receive tablets PRN warfarin/matching placebo to maintain a target INR of 2.0-3.0

Interventions: intervention 1: Warfarin intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: PRN (to maintain a target INR of 2.0-3.0) intervention 2: 150mg bid

Protocol document: