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Comparison of Platelet Inhibition With Adjunctive Cilostazol Versus High Maintenance-Dose Clopidogrel According to Hepatic Cytochrome 2C19 Allele (CYP2C19) Polymorphism (ACCEL2C19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00891670
Recruitment Status : Unknown
Verified April 2009 by Gyeongsang National University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 1, 2009
Last Update Posted : May 1, 2009
Information provided by:
Gyeongsang National University Hospital

Brief Summary:
The purpose of this study was to determine the impact of adjunctive cilostazol on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 allele.

Condition or disease Intervention/treatment Phase
Coronary Artery Stenosis Maximal Platelet Aggregation Late Platelet Aggregation High Post-Treatment Platelet Reactivity Drug: cilostazol Drug: clopidogrel Drug: aspirin Phase 3

Detailed Description:

The additional platelet inhibition with clopidogrel, a thienopyridine inhibitor of the platelet P2Y12 adenosine diphosphate (ADP) receptor, has reduced the risk of ischemic events after coronary stent implantation. Because of inter-individual variability in platelet response to clopidogrel, a significant proportion of suboptimal platelet inhibition has been reported. In addition, persistent residual platelet reactivity measured with platelet function testing has shown the association with the cardiovascular outcomes after percutaneous coronary intervention(PCI).

Various clinical factors and genetic polymorphisms have been studied to predict the degree of antiplatelet response to clopidogrel. Interestingly, recent studies found that carriers of the loss-of-function hepatic cytochrome (CYP) 2C19 allele had significantly lower levels of the active metabolite of clopidogrel, diminished platelet inhibition, and a higher rate of major adverse cardiovascular events than did non-carriers, in the setting of PCI and acute coronary syndrome(ACS). These findings raise the need of solutions to overcome enhanced post-clopidogrel platelet reactivity by the influence of the loss-of-function CYP2C19 allele. Increasing the dose of clopidogrel and new potent P2Y12 antagonists(such as prasugrel) may be alternative antiplatelet regimens in patients with the loss-of-function CYP variant.

Cilostazol reversibly induces platelet inhibition via its blockade of phosphodiesterase (PDE) type 3 and is catalysed mainly by CYP3A. A recent study demonstrated that adjunctive cilostazol to dual antiplatelet therapy (triple antiplatelet therapy) intensified platelet inhibition as compared with a high maintenance-dose (MD) of 150 mg/day. Therefore, triple antiplatelet therapy could also be an alternative antiplatelet therapy to improve platelet inhibition and clinical outcomes in carriers of CYP2C19 mutant allele.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Validation of Adjunctive Cilostazol According to CYP2C19 Polymorphism: Prospective, Randomized, Single-Center Trial:
Study Start Date : May 2009
Estimated Primary Completion Date : June 2009
Estimated Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: triple group
received cilostazol 100 mg twice daily in addition to aspirin 100mg and clopidogrel 75mg once daily
Drug: cilostazol
100mg twice daily for at least 1 month
Other Name: pletaal

Drug: aspirin
aspirin 100mg

Active Comparator: high maintenance dose group
received clopidogrel 150 mg/day with aspirin 100mg once daily
Drug: clopidogrel

75mg once daily (triple group arm)

150mg once daily (high maintenance dose group arm)

Other Name: plavix

Drug: aspirin
aspirin 100mg

Primary Outcome Measures :
  1. Reduction of maximal platelet aggregation [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Rate of high post-clopidogrel platelet reactivity [ Time Frame: 30 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The patient must be at least 18 years of age
  2. Significant coronary artery stenosis (> 70% by visual estimate)
  3. Elective coronary stent implantation

Exclusion Criteria:

  1. Acute myocardial infarction
  2. Hemodynamic instability active bleeding and bleeding diatheses
  3. Oral anticoagulation therapy with warfarin,use of peri-procedural glycoprotein IIb/IIIa inhibitors
  4. Contraindication to antiplatelet therapy
  5. Left ventricular ejection fraction < 30%
  6. Leukocyte count < 3,000/mm3, platelet count < 100,000/mm3
  7. AST or ALT ≥ 3 times upper normal
  8. Serum creatinine level ≥ 2.5 mg/dL
  9. stroke within 3 months
  10. Noncardiac disease with a life expectancy < 1 year
  11. Inability to follow the protocol

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 identifier (NCT number): NCT00891670

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Contact: Young-Hoon Jeong, MD, phD 82-55-750-8065

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Korea, Republic of
Gyeong-Sang National University Hospital
Jinju, Gyeong-Nam, Korea, Republic of, 660-702
Principal Investigator: Young-Hoon Jeong, MD, PHD         
Sponsors and Collaborators
Gyeongsang National University Hospital
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Principal Investigator: Young-Hoon Jeong, MD, phD Gyeong-Sang Natinal University Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Young-Hoon Jeong, Gyeongsang National University Hospital Identifier: NCT00891670    
Other Study ID Numbers: GCS-0901-D
First Posted: May 1, 2009    Key Record Dates
Last Update Posted: May 1, 2009
Last Verified: April 2009
Keywords provided by Gyeongsang National University Hospital:
CYP2C19 polymorphism
Adjunctive cilostazol
high maintenance dose clopidogrel
P2Y12 Reaction Unit
Additional relevant MeSH terms:
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Platelet Aggregation Inhibitors
Coronary Stenosis
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Bronchodilator Agents