Conditions: Arthroplasty, Replacement, Knee Thromboembolism
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2101
Healthy volunteers: no

Brief summary:
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the ef ficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsule s \[150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery\] comp ared to subcutaneous enoxaparin 40 mg once daily for 6 to 10 days, in prevention of venous thromboem bolism in patients with primary elective total knee replacement surgery. RE-MODEL (Thromboembolism prevention after knee surgery)

Detailed description:

Arms:
arm 1: 220 mg once daily arm 2: 150 mg once daily arm 3: 40 mg once daily

Interventions: intervention 1: enoxaparin intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate
Intervention descriptions: intervention 1: 40 mg once daily intervention 2: 150 mg once daily intervention 3: 220 mg once daily

Protocol document: