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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
Unnamed facility
Aalst, Belgium
Unnamed facility
Bad Nauheim, Germany
Unnamed facility
Cologne, Germany
Unnamed facility
Dachau, Germany
Unnamed facility
Activated Clotting Time (ACT) Value After the First Dosing of Study Treatment.
Time frame: 5 - 10 min after initial bolus
Composite and Each of Death, Myocardial Infarction, and Urgent Revascularisation at Day 30, and Major Bleeding Events During Hospital Stay.
Composite end point (a): all cause death, myocardial infarction and urgent revascularization at Day30 Composite end point (b): all cause death, myocardial infarction and urgent revascularization at Day30 as well as major bleeding events during hospital stay
Time frame: 30 Days
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Düren, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Halle, Germany
Unnamed facility
Mainz, Germany