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

NCT00620646 | Completed

• 1 other identifier: 2006-12-026
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Clopidogrel Non-Responsiveness

Keywords

clopidogrel; platelets; percutaneous coronary intervention

Outcome Measures

Primary Outcomes (1)

• % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test

  4 weeks

Secondary Outcomes (1)

• P2Y12 reaction unit (PRU)

  4 weeks

Study Arms (2)

A

EXPERIMENTAL

Aspirin plus increasing clopidogrel group

Drug: aspirin, clopidogrel

B

EXPERIMENTAL

Aspirin, clopidogrel plus cilostazol group

Drug: aspirin, clopidogrel, cilostazol

Interventions

aspirin, clopidogrel DRUG

aspirin 100 mg plus clopidogrel 150mg qd

A

aspirin, clopidogrel, cilostazol DRUG

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

B

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

MeSH Terms

Interventions

Aspirin; Clopidogrel; Cilostazol

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tetrazoles; Azoles; Quinolines

Study Officials

• Hyeon-Cheol Gwon, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 27, 2008
• First Posted: February 21, 2008
• Study Start: February 1, 2008
• Primary Completion: December 1, 2008
• Study Completion: February 1, 2009
• Last Updated: February 12, 2009

Record last verified: 2009-02

Locations

KR (1)