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

NCT ID: NCT00620646

Last Updated: 2009-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2009-02-28

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.

Conditions

Clopidogrel Non-Responsiveness

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Aspirin plus increasing clopidogrel group

Group Type: EXPERIMENTAL

aspirin, clopidogrel

Intervention Type: DRUG

aspirin 100 mg plus clopidogrel 150mg qd

B

Aspirin, clopidogrel plus cilostazol group

Group Type: EXPERIMENTAL

aspirin, clopidogrel, cilostazol

Intervention Type: DRUG

aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

Interventions

aspirin, clopidogrel

aspirin 100 mg plus clopidogrel 150mg qd

Intervention Type: DRUG

aspirin, clopidogrel, cilostazol

aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

Intervention Type: DRUG

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Samsung Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Samsung Medical Center

Principal Investigators

Hyeon-Cheol Gwon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Samsung Medical Center

Seoul, , South Korea

Countries

South Korea

Other Identifiers

2006-12-026

Identifier Type: -

Identifier Source: org_study_id