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The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol (4C-DES)

This study has been completed.
Information provided by:
Samsung Medical Center Identifier:
First received: January 27, 2008
Last updated: February 11, 2009
Last verified: February 2009
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

Condition Intervention
Clopidogrel Non-Responsiveness
Drug: aspirin, clopidogrel
Drug: aspirin, clopidogrel, cilostazol

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Comparison of Effects Between Increased Dose of Clopidogrel and Addition of Cilostazol in Clopidogrel Non-Responders After Drug-Eluting Stent Implantation

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • % platelet inhibition with VeryfyNow-P2Y12 assay, platelet function test [ Time Frame: 4 weeks ]

Secondary Outcome Measures:
  • P2Y12 reaction unit (PRU) [ Time Frame: 4 weeks ]

Estimated Enrollment: 80
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Aspirin plus increasing clopidogrel group
Drug: aspirin, clopidogrel
aspirin 100 mg plus clopidogrel 150mg qd
Experimental: B
Aspirin, clopidogrel plus cilostazol group
Drug: aspirin, clopidogrel, cilostazol
aspirin 100mg qd,clopidogrel 75mg qd plus cilostazol 100mg bid

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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)
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Please refer to this study by its identifier: NCT00620646

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Hyeon-Cheol Gwon, MD, PhD Samsung Medical Center
  More Information

Responsible Party: HC Gwon, Samsung Medical Center Identifier: NCT00620646     History of Changes
Other Study ID Numbers: 2006-12-026
Study First Received: January 27, 2008
Last Updated: February 11, 2009

Keywords provided by Samsung Medical Center:
percutaneous coronary intervention

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Cytochrome P-450 CYP2C19 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents processed this record on April 27, 2017