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OpenTrials
Completed

NCT Number: NCT00620646

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

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

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Samsung Medical Center

Seoul, 135-710, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Aspirin, Clopidogrel

Drug

aspirin 100 mg plus clopidogrel 150mg qd

aspirin, clopidogrel, cilostazol

Drug

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

Primary outcomes

  1. % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test

    Time frame: 4 weeks

Secondary outcomes

  1. P2Y12 reaction unit (PRU)

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation

Acronym: 4C-DES

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Feb 21, 2008
Registry last updated
Feb 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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