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

This study has been completed.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00620646
First received: January 27, 2008
Last updated: February 11, 2009
Last verified: February 2009
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • P2Y12 reaction unit (PRU) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: HC Gwon, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00620646     History of Changes
Other Study ID Numbers: 2006-12-026
Study First Received: January 27, 2008
Last Updated: February 11, 2009
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Aspirin
Cilostazol
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
 Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Bronchodilator Agents

ClinicalTrials.gov processed this record on May 16, 2013