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

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ClinicalTrials.gov Identifier: NCT00620646
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 12, 2009
Sponsor:
Information provided by:
Samsung Medical Center

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

Condition or disease Intervention/treatment Phase
Clopidogrel Non-Responsiveness Drug: aspirin, clopidogrel Drug: aspirin, clopidogrel, cilostazol Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : February 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00620646


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

Responsible Party: HC Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00620646     History of Changes
Other Study ID Numbers: 2006-12-026
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 12, 2009
Last Verified: February 2009

Keywords provided by Samsung Medical Center:
clopidogrel
platelets
percutaneous coronary intervention

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