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Sponsored by: |
Mitsubishi Tanabe Pharma Corporation |
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Information provided by: | Mitsubishi Tanabe Pharma Corporation |
ClinicalTrials.gov Identifier: | NCT00508924 |
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.
Condition | Intervention | Phase |
---|---|---|
Coronary Artery Disease Angina, Unstable |
Drug: Argatroban |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacokinetics/Dynamics Study |
Official Title: | A Randomised, Open, Parallel-Group, Multicentre Study to Examine the Safety and Effectiveness of Three Doses of Argatroban as Anticoagulant in Combination With Clopidogrel and Aspirin in Patients Undergoing Elective Percutaneous Coronary Intervention in Comparison With Unfractionated Heparin, Clopidogrel and Aspirin |
Enrollment: | 140 |
Study Start Date: | August 2005 |
Study Completion Date: | October 2006 |
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Belgium | |
Aalst, Belgium | |
Germany | |
Frankfurt, Germany | |
Mainz, Germany | |
Bad Nauheim, Germany | |
Halle, Germany | |
Dueren, Germany | |
Dachau, Germany | |
Cologne, Germany |
Principal Investigator: | Professor | Information at Mitsubishi Pharma Europe |
Study ID Numbers: | ARG-E04 |
Study First Received: | July 26, 2007 |
Last Updated: | July 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00508924 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Argatroban Direct thrombin inhibitor Percutaneous coronary intervention |
Activated clotting time PCI ACT |
Thrombin Arterial Occlusive Diseases Heart Diseases Heparin, Low-Molecular-Weight Myocardial Ischemia Angina Pectoris Vascular Diseases Pain Ischemia Arteriosclerosis |
Calcium heparin Chest Pain Coronary Disease Signs and Symptoms Argatroban Aspirin Clopidogrel Heparin Angina, Unstable Coronary Artery Disease |
Anticoagulants Therapeutic Uses Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |