NCT01012193

Brief Summary

The purpose of this study is to determine the impact of adjunctive cilostazol versus high maintenance-dose clopidogrel on platelet inhibition in carriers and non-carriers of the loss-of-function CYP2C19 mutant allele.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P25-P50 for phase_4 coronary-artery-disease

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_4 coronary-artery-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
Last Updated

May 17, 2011

Status Verified

May 1, 2011

Enrollment Period

1.5 years

First QC Date

November 10, 2009

Last Update Submit

May 15, 2011

Conditions

Coronary Artery DiseasePercutaneous Coronary Intervention

Keywords

adjunctive cilostazolhigh-MD clopidogrelCYP 2C19 polymorphismhigh risk patients

Outcome Measures

Primary Outcomes (1)

  • Reduction of maximal platelet aggregation according to CYP 2C19 polymorphism

    30-day therapy

Secondary Outcomes (1)

  • Reduction of late platelet aggregation, reduction of P2Y12 reaction unit, and the rate of high post-clopidogrel platelet reactivity according to CYP 2C19 polymorphism

    30-day therapy

Study Arms (2)

adjunctive cilostazol

ACTIVE COMPARATOR

adjunctive cilostazol 100mg bid to dual antiplatelet therapy

Drug: cilostazol 100mg bid or clopidogrel 150-mg daily

high maintenance-dose clopidogrel

ACTIVE COMPARATOR

double dose of clopidogrel 150mg/day

Drug: cilostazol 100mg bid or clopidogrel 150-mg daily

Interventions

cilostazol 100mg bid or clopidogrel 150-mg dailyDRUG

Adjunctive cilostazol: cilostazol 100-mg bid +clopidogrel 75mg daily+aspirin 200mg daily High-MD clopidogrel: clopidogrel 150mg daly +aspirin 200mg daily

adjunctive cilostazolhigh maintenance-dose clopidogrel

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Significant coronary artery stenosis (\>70% by visual estimate)
  • Elective coronary stent implantation

You may not qualify if:

  • Acute myocardial infarction
  • Active bleeding and bleeding diatheses
  • Hemodynamic instability
  • Oral anticoagulation therapy with warfarin
  • Use of peri-procedural glycoprotein IIb/IIIa inhibitors
  • Contraindication to antiplatelet therapy
  • Left ventricular ejection fraction \< 30%
  • Leukocyte count \< 3,000/mm3, platelet count \< 100,000/mm3, AST or ALT ≥ 3 times upper normal
  • Serum creatinine level ≥ 3 mg/dL
  • Stroke within 3 months
  • Noncardiac disease with a life expectancy \< 1 year
  • Inability to follow the protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 660-702, South Korea

Location

Related Publications (3)

  • Jeong YH, Tantry US, Park Y, Kwon TJ, Park JR, Hwang SJ, Bliden KP, Koh EH, Kwak CH, Hwang JY, Kim S, Gurbel PA. Pharmacodynamic effect of cilostazol plus standard clopidogrel versus double-dose clopidogrel in patients with type 2 diabetes undergoing percutaneous coronary intervention. Diabetes Care. 2012 Nov;35(11):2194-7. doi: 10.2337/dc11-2351. Epub 2012 Jul 26.

    PMID: 22837373DERIVED

  • Kim IS, Jeong YH, Park Y, Yoon SE, Kwon TJ, Park JR, Hwang SJ, Koh EH, Kwak CH, Hwang JY, Kim S. Interaction analysis between genetic polymorphisms and pharmacodynamic effect in patients treated with adjunctive cilostazol to dual antiplatelet therapy: results of the ACCEL-TRIPLE (Accelerated Platelet Inhibition by Triple Antiplatelet Therapy According to Gene Polymorphism) study. Br J Clin Pharmacol. 2012 Apr;73(4):629-40. doi: 10.1111/j.1365-2125.2011.04131.x.

    PMID: 22007612DERIVED

  • Hwang SJ, Jeong YH, Kim IS, Park KS, Kang MK, Koh JS, Park JR, Park Y, Koh EH, Kwak CH, Hwang JY, Kim S. Cytochrome 2C19 polymorphism and response to adjunctive cilostazol versus high maintenance-dose clopidogrel in patients undergoing percutaneous coronary intervention. Circ Cardiovasc Interv. 2010 Oct;3(5):450-9. doi: 10.1161/CIRCINTERVENTIONS.110.949859. Epub 2010 Sep 7.

    PMID: 20823393DERIVED

Related Links

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

CilostazolBID protein, humanClopidogrel

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridines

Study Officials

  • Young-Hoon Jeong, MD, PhD

    Gyeongsang National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

January 1, 2008

Primary Completion

July 1, 2009

Study Completion

September 1, 2009

Last Updated

May 17, 2011

Record last verified: 2011-05

Locations

KR(1)