NCT00891670

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2009

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

April 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

May 1, 2009

Status Verified

April 1, 2009

Enrollment Period

1 month

First QC Date

April 30, 2009

Last Update Submit

April 30, 2009

Conditions

Coronary Artery StenosisMaximal Platelet AggregationLate Platelet AggregationHigh Post-Treatment Platelet Reactivity

Keywords

CYP2C19 polymorphismplateletAdjunctive cilostazolhigh maintenance dose clopidogrelP2Y12 Reaction Unit

Outcome Measures

Primary Outcomes (1)

  • Reduction of maximal platelet aggregation

    30 days

Secondary Outcomes (1)

  • Rate of high post-clopidogrel platelet reactivity

    30 days

Study Arms (2)

triple group

ACTIVE COMPARATOR

received cilostazol 100 mg twice daily in addition to aspirin 100mg and clopidogrel 75mg once daily

Drug: cilostazolDrug: aspirin

high maintenance dose group

ACTIVE COMPARATOR

received clopidogrel 150 mg/day with aspirin 100mg once daily

Drug: clopidogrelDrug: aspirin

Interventions

cilostazolDRUG

100mg twice daily for at least 1 month

Also known as: pletaal
triple group
clopidogrelDRUG

75mg once daily (triple group arm) 150mg once daily (high maintenance dose group arm)

Also known as: plavix
high maintenance dose group
aspirinDRUG

aspirin 100mg

high maintenance dose grouptriple group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • Acute myocardial infarction
  • Hemodynamic instability active bleeding and bleeding diatheses
  • 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 ≥ 2.5 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)

Gyeong-Sang National University Hospital

Jinju, Gyeong-Nam, 660-702, South Korea

Location

Related Publications (2)

  • Jeong YH, Abadilla KA, Tantry US, Park Y, Koh JS, Kwak CH, Hwang JY, Gurbel PA. Influence of CYP2C19*2 and *3 loss-of-function alleles on the pharmacodynamic effects of standard- and high-dose clopidogrel in East Asians undergoing percutaneous coronary intervention: the results of the ACCEL-DOUBLE-2N3 study. J Thromb Haemost. 2013 Jun;11(6):1194-7. doi: 10.1111/jth.12200. No abstract available.

    PMID: 23517020DERIVED

  • Jeong YH, Kim IS, Park Y, Kang MK, Koh JS, Hwang SJ, Kwak CH, Hwang JY. Carriage of cytochrome 2C19 polymorphism is associated with risk of high post-treatment platelet reactivity on high maintenance-dose clopidogrel of 150 mg/day: results of the ACCEL-DOUBLE (Accelerated Platelet Inhibition by a Double Dose of Clopidogrel According to Gene Polymorphism) study. JACC Cardiovasc Interv. 2010 Jul;3(7):731-41. doi: 10.1016/j.jcin.2010.05.007.

    PMID: 20650435DERIVED

MeSH Terms

Conditions

Coronary Stenosis

Interventions

CilostazolClopidogrelAspirin

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

TetrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTiclopidineThienopyridinesThiophenesSulfur CompoundsOrganic ChemicalsPyridinesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Young-Hoon Jeong, MD, phD

    Gyeong-Sang Natinal University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Young-Hoon Jeong, MD, phD

CONTACT

82-55-750-8065goodoctor@naver.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 30, 2009

First Posted

May 1, 2009

Study Start

May 1, 2009

Primary Completion

June 1, 2009

Study Completion

July 1, 2009

Last Updated

May 1, 2009

Record last verified: 2009-04

Locations

KR(1)