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Sponsored by: |
Charles University, Czech Republic |
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Information provided by: | Charles University, Czech Republic |
ClinicalTrials.gov Identifier: | NCT00839345 |
The purpose of the study is to determine, whether the resistance to clopidogrel could be affected by higher doses of this drug, or by replacement of clopidogrel with another ADP-antagonist ticlopidine.
Condition | Intervention |
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Coronary Artery Disease |
Drug: clopidogrel |
Study Type: | Expanded Access |
Official Title: | Resistance to Antiplatelet Agents, Its Etiology and the Possibility of Its Affection |
Patients after percutaneous coronary intervention (PCI) with stent implantation have to be treated by dual antiplatelet therapy, which standard part represents clopidogrel. The response to clopidogrel in population exhibits wide interindividual variability. According to some recent works, patients with clopidogrel resistance are in higher risk for recurrence of myocardial infarction in comparison with the patients with sufficient clopidogrel effectiveness. The treatment of clopidogrel resistance is still unknown. Our project should contribute to the better understanding of the clinical impact of clopidogrel resistance and its genetical determination. We will test the hypothesis, whether the clopidogrel resistance could be influenced by higher dose of this drug or by replacement to ticlopidine (ADP antagonist with different biotransformation in the liver). Therefore, 500 pts. will be tested to clopidogrel resistance. We expect 5-10% of resistent pts. This pts. will be treated by higher dose (150mg or 225mg/day) with repeated tests of clopidogrel effectiveness after each dose enhancement. If 225mg/day will be insufficient, clopidogrel will be replaced by ticlopidine with repeated test.
We expect, that better definition of clinical and and genetic correlate of clopidogrel resistance will improve our knowledge of this disorder.
Nevertheless, the achievement of sufficient effect of clopidogrel in some still resistant patients will lead to the improvement of the treatment
Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Charles University, Czech republic ( Pavel Osmancik ) |
Study ID Numbers: | CLO-OSM-01 |
Study First Received: | February 6, 2009 |
Last Updated: | February 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00839345 History of Changes |
Health Authority: | Czech Republic: State Institute for Drug Control |
platelet clopidogrel VerifyNow ticlopidine thrombosis |
Arterial Occlusive Diseases Coronary Disease Ticlopidine Heart Diseases Clopidogrel Myocardial Ischemia |
Vascular Diseases Platelet Aggregation Inhibitors Arteriosclerosis Ischemia Thrombosis Coronary Artery Disease |
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 |