Conditions: Heart Valve Diseases
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 328
Healthy volunteers: no

Brief summary:
To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.

Detailed description:

Arms:
arm 1: Patient dose dependent on screening CrCl levels and TT arm 2: warfarin doses to maintain INR levels

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

Protocol document: