Conditions: Atrial Fibrillation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 502
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate the safety of different doses of BIBR 1048, alone or in combination with acetylsalicylic acid (ASA), as determined by the rates of bleeding and other adverse events.

A secondary objective of this trial is to evaluate the anticoagulant effect of different doses of BIBR 1048, based on the reduction of plasma concentrations of D-dimer, a laboratory marker for activated coagulation in patients with atrial fibrillation (AF), and to correlate bleeding and other events with pharmacokinetic (PK) and pharmacodynamic (PD) data.

Detailed description:

Arms:
arm 1: Dabigatran: one capsule in the morning and 1 capsule in the evening. Twice daily (bis in die = bid). arm 2: Dabigatran: one capsule in the morning and 1 capsule in the evening. Acetylsalicylic acid (ASA) once daily (quaque dies = qd) in the morning. arm 3: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 4: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 5: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 6: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 7: Dabigatran: one capsule in the morning and 1 capsule in the evening arm 8: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 9: Dabigatran: one capsule in the morning and 1 capsule in the evening. ASA in the morning arm 10: once daily, dosed to target International Normalised Ratio (INR) 2.0 to 3.0

Interventions: intervention 1: dabigatran with ASA intervention 2: dabigatran with ASA intervention 3: dabigatran with ASA intervention 4: dabigatran with ASA intervention 5: dabigatran with ASA intervention 6: dabigatran with ASA intervention 7: warfarin intervention 8: dabigatran without ASA intervention 9: dabigatran without ASA intervention 10: dabigatran without ASA
Intervention descriptions: intervention 1: dose comparison in combination intervention 2: dose comparison in combination intervention 3: dose comparison in combination intervention 4: dose comparison in combination intervention 5: dose comparison in combination intervention 6: dose comparison in combination intervention 7: comparator intervention 8: dose comparison intervention 9: dose comparison intervention 10: dose comparison

Protocol document: