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Sponsored by: |
Gyeongsang National University Hospital |
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Information provided by: | Gyeongsang National University Hospital |
ClinicalTrials.gov Identifier: | NCT00891670 |
The purpose of this study was to determine the impact of adjunctive cilostazol on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.
Condition | Intervention | Phase |
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Coronary Artery Stenosis Maximal Platelet Aggregation Late Platelet Aggregation High Post-Treatment Platelet Reactivity |
Drug: cilostazol Drug: clopidogrel Drug: aspirin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Pharmacodynamics Study |
Official Title: | Validation of Adjunctive Cilostazol According to CYP2C19 Polymorphism: Prospective, Randomized, Single-Center Trial: |
Estimated Enrollment: | 80 |
Study Start Date: | May 2009 |
Estimated Study Completion Date: | July 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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triple group: Active Comparator
received cilostazol 100 mg twice daily in addition to aspirin 100mg and clopidogrel 75mg once daily
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Drug: cilostazol
100mg twice daily for at least 1 month
Drug: aspirin
aspirin 100mg
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high maintenance dose group: Active Comparator
received clopidogrel 150 mg/day with aspirin 100mg once daily
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Drug: clopidogrel
75mg once daily (triple group arm) 150mg once daily (high maintenance dose group arm)
aspirin 100mg
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The additional platelet inhibition with clopidogrel, a thienopyridine inhibitor of the platelet P2Y12 adenosine diphosphate (ADP) receptor, has reduced the risk of ischemic events after coronary stent implantation. Because of inter-individual variability in platelet response to clopidogrel, a significant proportion of suboptimal platelet inhibition has been reported. In addition, persistent residual platelet reactivity measured with platelet function testing has shown the association with the cardiovascular outcomes after percutaneous coronary intervention(PCI).
Various clinical factors and genetic polymorphisms have been studied to predict the degree of antiplatelet response to clopidogrel. Interestingly, recent studies found that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events than did non-carriers, in the setting of PCI and acute coronary syndrome(ACS). These findings raise the need of solutions to overcome enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function CYP2C19 allele. Increasing the dose of clopidogrel and new potent P2Y12 antagonists(such as prasugrel) may be alternative antiplatelet regimens in patients with the loss-of-function CYP variant. Cilostazol reversibly induces platelet inhibition via its blockade of phosphodiesterase (PDE) type 3 and is catalysed mainly by CYP3A. A recent study demonstrated that adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore, triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Young-Hoon Jeong, MD, phD | 82-55-750-8065 | goodoctor@naver.com |
Korea, Republic of, Gyeong-Nam | |
Gyeong-Sang National University Hospital | |
Jinju, Gyeong-Nam, Korea, Republic of, 660-702 |
Principal Investigator: | Young-Hoon Jeong, MD, phD | Gyeong-Sang Natinal University Hospital |
Responsible Party: | Gyeongsang National University Hospital ( Young-Hoon Jeong ) |
Study ID Numbers: | GCS-0901-D |
Study First Received: | April 30, 2009 |
Last Updated: | April 30, 2009 |
ClinicalTrials.gov Identifier: | NCT00891670 History of Changes |
Health Authority: | Korea: Food and Drug Administration |
CYP2C19 polymorphism platelet Adjunctive cilostazol high maintenance dose clopidogrel P2Y12 Reaction Unit |
Cilostazol Vasodilator Agents Heart Diseases Myocardial Ischemia Vascular Diseases Anti-Asthmatic Agents Fibrinolytic Agents Constriction, Pathologic Cardiovascular Agents Ischemia Neuroprotective Agents |
Coronary Stenosis Coronary Disease Fibrin Modulating Agents Phosphodiesterase Inhibitors Aspirin Clopidogrel Platelet Aggregation Inhibitors Peripheral Nervous System Agents Bronchodilator Agents Coronary Artery Disease |
Respiratory System Agents Vasodilator Agents Molecular Mechanisms of Pharmacological Action Myocardial Ischemia Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Neuroprotective Agents Fibrin Modulating Agents Therapeutic Uses Cardiovascular Diseases Cilostazol Heart Diseases Vascular Diseases |
Anti-Asthmatic Agents Enzyme Inhibitors Cardiovascular Agents Protective Agents Coronary Stenosis Pharmacologic Actions Coronary Disease Phosphodiesterase Inhibitors Autonomic Agents Clopidogrel Platelet Aggregation Inhibitors Peripheral Nervous System Agents Central Nervous System Agents Bronchodilator Agents |