Conditions: Coronary Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1878
Healthy volunteers: no

Brief summary:
The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events.

Detailed description:

Arms:
arm 1: twice daily dosing, arm 2: twice daily dosing, patients with moderate renal impairment allocated 50mg bid arm 3: twice daily dosing, patients with moderate renal impairment allocated 75mg bid arm 4: twice daily dosing, patients with moderate renal impairment allocated 110mg bid arm 5: matched placebo

Interventions: intervention 1: placebo intervention 2: dabigatran etexilate intervention 3: dabigatran etexilate intervention 4: dabigatran etexilate intervention 5: dabigatran etexilate
Intervention descriptions: intervention 1: matched placebo intervention 2: capsules, twice daily, 26 weeks treatment intervention 3: capsules, twice daily, 26 weeks treatment intervention 4: capsules, twice daily, 26 weeks treatment intervention 5: capsules, twice daily, 26 weeks treatment

Protocol document: