Status:
COMPLETED
The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
Lead Sponsor:
Samsung Medical Center
Conditions:
Clopidogrel Non-Responsiveness
Eligibility:
All Genders
Phase:
NA
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 poten...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00620646
Start Date
February 1 2008
End Date
February 1 2009
Last Update
February 12 2009
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 135-710