The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Clopidogrel Non-Responsiveness
Intervention: aspirin, clopidogrel (Drug); aspirin, clopidogrel, cilostazol (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samsung Medical Center Official(s) and/or principal investigator(s):
Hyeon-Cheol Gwon, MD, PhD, Principal Investigator, Affiliation: Samsung Medical Center
Overall contact:
Hyeon-Cheol Gwon, MD,PhD, Phone: 82-2-3410-3418, Email: hcgwon@smc.samsung.co.kr
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
Clinical Details
Official title: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test
Secondary outcome: P2Y12 reaction unit (PRU)
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Hyeon-Cheol Gwon, MD,PhD, Phone: 82-2-3410-3418, Email: hcgwon@smc.samsung.co.kr
Samsung Medical Center, Seoul 135-710, Korea, Republic of; Recruiting
Hyeon-Cheol Gwon, Professor, Phone: 82234103419, Email: hc.gwon@samsung.com
Additional Information
Starting date: February 2008
Ending date: December 2008
Last updated: February 10, 2008
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