Conditions: Venous Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2055
Healthy volunteers: no

Brief summary:
The primary objective of the trial is to demonstrate non-inferiority of 220 mg oral dabigatran etexilate compared to 40 mg subcutaneous enoxaparin administered once daily. Safety and efficacy will be compared between the treatment groups.

Detailed description:

Arms:
arm 1: 220 mg once daily arm 2: 40 mg once daily

Interventions: intervention 1: Enoxaparin intervention 2: Dabigatran etexilate
Intervention descriptions: intervention 1: 40 mg once daily intervention 2: 220 mg once daily

Protocol document: