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

April 30, 2009 updated by: Gyeongsang National University Hospital

Validation of Adjunctive Cilostazol According to CYP2C19 Polymorphism: Prospective, Randomized, Single-Center Trial:

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeong-Nam
      • Jinju, Gyeong-Nam, Korea, Republic of, 660-702
        • Gyeong-Sang National University Hospital
        • Principal Investigator:
          • Young-Hoon Jeong, MD, PHD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • pletaal
Drug: aspirin
aspirin 100mg
Active Comparator: high maintenance dose group
received clopidogrel 150 mg/day with aspirin 100mg once daily
Drug: aspirin
aspirin 100mg
Drug: clopidogrel

75mg once daily (triple group arm)

150mg once daily (high maintenance dose group arm)

Other Names:
  • plavix

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reduction of maximal platelet aggregation
Time Frame: 30 days
30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of high post-clopidogrel platelet reactivity
Time Frame: 30 days
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Investigators

  • Principal Investigator: Young-Hoon Jeong, MD, phD, Gyeong-Sang Natinal University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Anticipated)

June 1, 2009

Study Completion (Anticipated)

July 1, 2009

Study Registration Dates

First Submitted

April 30, 2009

First Submitted That Met QC Criteria

April 30, 2009

First Posted (Estimate)

May 1, 2009

Study Record Updates

Last Update Posted (Estimate)

May 1, 2009

Last Update Submitted That Met QC Criteria

April 30, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCS-0901-D

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Stenosis

Clinical Trials on cilostazol

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Lebanon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe