Conditions: Coronary Artery Disease Angina, Unstable
Keywords: Argatroban Direct thrombin inhibitor Percutaneous coronary intervention Activated clotting time PCI ACT
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 140
Healthy volunteers: no

Brief summary:
This is a phase II multi-centre study in 140 patients undergoing elective PCI to obtain the information on dose-response of argatroban in pharmacodynamic markers and to assess the anticoagulation, safety and efficacy of argatroban in reference to unfractionated heparin, in combination with dual antiplatelet therapy.

Detailed description:
This is a phase II multi-centre study in Europe in patients with stable coronary artery disease or troponin negative unstable angina undergoing elective PCI, to obtain the information on the safety and effects on various pharmacodynamic markers, of three doses of argatroban in combination with clopidogrel and aspirin, and to assess the results of argatroban and unfractionated heparin, both used in combination with clopidogrel and aspirin, on clinical outcomes, adequacy of anticoagulation, various pharmacodynamic markers (approximately 35 patients per group).

Arms:
arm 1: None arm 2: None arm 3: None arm 4: None

Interventions: intervention 1: Argatroban intervention 2: Argatroban intervention 3: Argatroban intervention 4: Heparin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: