The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol

Not Applicable

Completed

• Conditions: Clopidogrel Non-Responsiveness
• Interventions: Drug: aspirin, clopidogrel; Drug: aspirin, clopidogrel, cilostazol

• Registration Number: NCT00620646
• Lead Sponsor: Samsung Medical Center

Brief Summary

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

Detailed Description

Using dual antiplatelet agents with aspirin and clopidogrel is essential after drug-eluting stent implantation to prevent restenosis and stent thrombosis. However, variable platelet response and potential resistance to therapy have emerged with clopidogrel. Several studies showed that clopidogrel resistance is associated with increased cardiovascular events after coronary interventions. New antiplatelet therapeutic strategy of is needed in case of clopidogrel resistance. We started this study to compare the effect of double dosing of clopidogrel to 150mg per day and adding cilostazol to standard dose of clopidogrel after the insertion of drug-eluting stent in patients with clopidogrel resistance.

Study Timeline

• Study First Submitted: 2008-01-27
• Study Start: 2008-02
• Study First Submitted QC: 2008-02-10
• Study First Posted: 2008-02-21
• Primary Completion: 2008-12
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-11
• Last Update Posted: 2009-02-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	aspirin, clopidogrel	Aspirin plus increasing clopidogrel group
B	aspirin, clopidogrel, cilostazol	Aspirin, clopidogrel plus cilostazol group

Primary Outcome Measures

Name	Time	Method
% platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test	4 weeks

Secondary Outcome Measures

Name	Time	Method
P2Y12 reaction unit (PRU)	4 weeks

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of