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| Sponsor: | Deutsches Herzzentrum Muenchen |
|---|---|
| Collaborator: |
Technische Universität München |
| Information provided by: | Deutsches Herzzentrum Muenchen |
| ClinicalTrials.gov Identifier: | NCT00140465 |
Purpose
The purpose of the study is to test whether an increase of the maintenance dose of clopidogrel from 75 to 150 mg per day results in an additional suppression of ADP-induced platelet aggregation
| Condition | Intervention | Phase |
|---|---|---|
|
Coronary Disease |
Drug: Clopidogrel |
Phase IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Double-Blind, Randomized Comparison Between Two Different Clopidogrel Maintenance Doses After Percutaneous Coronary Intervention (ISAR-CHOICE-2) |
| Enrollment: | 60 |
| Study Start Date: | October 2004 |
| Study Completion Date: | July 2005 |
| Arms | Assigned Interventions |
|---|---|
|
1: Active Comparator
75 mg Clopidogrel Maintenance Doses
|
Drug: Clopidogrel
after PCI
|
|
2: Active Comparator
150 mg Clopidogrel Maintenance Doses
|
Drug: Clopidogrel
after PCI
|
In patients treated with coronary stents clopidogrel therapy is usually initiated with a 300 to 600 mg loading dose. In the CREDO trial it was shown that a 300 mg loading dose results in a reduction of ischemic events after percutaneous coronary intervention (PCI) if given 6 hours prior to the procedure. An antiplatelet effect similar to that achieved by chronic therapy with 75 mg/day is reached within 2 hours when the high 600 mg loading is administered. The 600 mg loading dose has been shown to be safe and effective in preventing thrombotic events following coronary stent implantation. Recently, it was shown that in patients with stable angina and administration of the 600 mg loading dose at least two hours prior to PCI concomitant therapy with a GP IIb/IIIa antagonist does not result in a further reduction of the incidence of thrombotic events. In contrast to a number of investigations with different loading doses, no trials have been performed comparing different clopidogrel maintenance doses. Recently, it was shown that administration of a 600 mg loading dose in patients already on chronic clopidogrel therapy (75 mg/day) results in an additional significant increase in inhibition of adenosine diphosphate (ADP-) induced platelet aggregation. Therefore, it is possible that an increase of the clopidogrel maintenance dose in patients with chronic clopidogrel therapy also results in a more pronounced inhibition of platelet aggregation.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Germany | |
| Deutsches Herzzentrum Muenchen | |
| Munich, Germany, 80636 | |
| Study Chair: | Albert Schomig, MD | Deutsches Herzzentrum Muenchen |
| Study Director: | Adnan Kastrati, MD | Deutsches Herzzentrum Muenchen |
| Principal Investigator: | Nicolas von Beckerath, MD | Deutsches Herzzentrum Muenchen |
More Information
| Study ID Numbers: | GE IDE No. A00803 |
| Study First Received: | August 31, 2005 |
| Last Updated: | November 13, 2007 |
| ClinicalTrials.gov Identifier: | NCT00140465 History of Changes |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
Arterial Occlusive Diseases Heart Diseases Myocardial Ischemia Hematologic Agents Vascular Diseases Arteriosclerosis Pharmacologic Actions |
Coronary Disease Clopidogrel Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Coronary Artery Disease |