Conditions: Thromboembolism Heart Valve Prosthesis
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
To collect additional data relating to safety and indicators of efficacy for patients who have participated in the 1160.113 study.

Detailed description:

Arms:
arm 1: Patient dose determined by dose allocated in 1160.113 and CrCl levels arm 2: warfarin doses to maintain INR levels

Interventions: intervention 1: dabigatran etexilate low dose intervention 2: warfarin 5mg intervention 3: dabigatran etexilate intermediate dose intervention 4: warfarin 1mg intervention 5: dabigatran etexilate high dose intervention 6: warfarin 3mg
Intervention descriptions: intervention 1: active treatment (low) intervention 2: comparator warfarin intervention 3: active treatment (medium) intervention 4: comparator warfarin intervention 5: active treatment (high) intervention 6: comparator warfarin

Protocol document: