4C-DES
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
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Status:
This study has been completed. Currently we are analyzing the data and preparing the paper (October 2009).
Purpose:
To compare the effect of increased dosing of clopidogrel and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.
Year Started:
2008
Year Finished:
2009
Design:
Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Inclusion Criteria
Patient with clopidogrel resistance with treatment of dual antiplatelet agent, aspirin and clopidogrel, for more than 4 weeks after drug-eluting stent; Clopidogrel resistance is defined as a patients with platelet inhibition less than 30% in platelet function test(VerifyNow-P2Y12 assayTM, Accumetrics, San Diego, CA, USA).
Exclusion Criteria
Acute myocardial infarction within 2 weeks; unstable angina within 2 weeks; history of using glycoprotein IIb/IIIa inhibitor within 1 month; cerebral infarction within 3 months; bleeding diathesis like coagulation disorder, thrombocytopenia (platelet count < 100,000/uL); history of gastrointestinal bleeding or genitourinary bleeding within 3 months; needed oral anticoagulation; aspirin, clopidogrel or cilostazol hypersensitivity; congestive heart failure; serum creatinine level >2mg/dl; malignancy; using cytochrome P450 inhibitor (eg, itraconazole).
Patient Involvement:
After the insertion of drug-eluting stent in patients with clopidogrel resistance, patient will be randomized to one of two arms: aspirin 100 mg plus clopidogrel 150mg qd
or aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid. Patient will have blood work after 4 weeks to look at drug levels and platelet function.
Primary Outcome:
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test.
Secondary Outcome:
P2Y12 reaction unit (PRU).
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/27/2009
Reviewed on: 10/19/2009.
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