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Sponsored by: |
Heart Center Bad Krozingen |
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Information provided by: | Heart Center Bad Krozingen |
ClinicalTrials.gov Identifier: | NCT00302913 |
This study is a prospective, single-center evaluation of the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation.
Condition | Intervention |
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Coronary Artery Disease Drug Resistance |
Drug: Adjustment of clopidogrel dose |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Adjusted Clopidogrel Dose in Patients With Insufficient Platelet Inhibition After Elective Coronary Stenting |
Estimated Enrollment: | 120 |
Study Start Date: | December 2005 |
Estimated Study Completion Date: | June 2006 |
Background: The EXCELSIOR trial demonstrated a 7-fold increased risk for death, myocardial infarction and target vessel reintervention within 30 days in patients with platelet inhibition below median of study cohort after a bolus dose of 600 mg of clopidogrel. The median of platelet inhibition in this cohort was 14 % optical aggregation after stimulation with 5 µM ADP.
Aim: To evaluate the efficacy of clopidogrel dose adjustment in patients with insufficient platelet inhibition after elective coronary stent implantation
Methods: This prospective, single-center study will evaluate antiplatelet effects in 120 patients receiving a bolus dose of 600 mg of clopidogrel before undergoing elective coronary stent implantation. Platelet inhibition will be evaluated 24 hours, 14 and 28 days after coronary intervention using optical aggregometry (5 µM ADP) and determination of surface protein expression by flow cytometry (P-Selectin, gp55, activated GP IIb/IIIa). If 24 hours after coronary stent implantation optical aggregation is >14 %, patients will receive an additional bolus dose of 300 mg of clopidogrel, followed by a daily dose of 150 mg for at least 28 days. If optical aggregation at this point of time is ≤14 % patients will receive a daily dose of 75 mg of clopidogrel. No further dose adjustments during follow up will be performed.
Hypothesis: Adjustment of clopidogrel dose in patients with insufficient platelet inhibition determined by optical aggregometry will provide a comparable antiplatelet effect as in patients with sufficient platelet inhibition after coronary stent implantation.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | HZ-BK-2005-2 |
Study First Received: | March 14, 2006 |
Last Updated: | June 29, 2006 |
ClinicalTrials.gov Identifier: | NCT00302913 |
Health Authority: | Germany: Ethics Commission |
Clopidogrel Coronary Artery Disease Dose-Response Relationship, Drug Drug Resistance PCI |
Arterial Occlusive Diseases Coronary Disease Heart Diseases Clopidogrel Myocardial Ischemia |
Vascular Diseases Arteriosclerosis Ischemia Coronary Artery Disease |
Therapeutic Uses Hematologic Agents Platelet Aggregation Inhibitors Cardiovascular Diseases Pharmacologic Actions |