NCT01094457

Brief Summary

Clopidogrel resistance (CR) or low-responsiveness is associated with increased risk of ischemic events and can be detected by laboratory tests. This multicenter, randomized study is aimed to explore the efficacy and safety of intensive antiplatelet therapy (i.e. double clopidogrel maintenance dose and/or additional cilostazol)for patients with CR after coronary stenting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
840

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2009

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 29, 2010

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

June 14, 2012

Status Verified

June 1, 2012

Enrollment Period

3.1 years

First QC Date

March 26, 2010

Last Update Submit

June 13, 2012

Conditions

Acute Coronary SyndromesPercutaneous Coronary InterventionClopidogrel Low Responsiveness

Keywords

antiplatelet therapyclopidogrel low responsivenessacute coronary syndromespercutaneous coronary interventioncilostazol

Outcome Measures

Primary Outcomes (1)

  • Major ischemic cardiovascular events

    defined as a composite of cardiac death, myocardial infarction or stroke

    1 year

Secondary Outcomes (4)

  • Stent thrombosis

    1 year

  • major adverse cardiac and cerebral events(MACCE)

    1 year

  • Hemorrhagic events

    within 1 year

  • reduction in ADP induced platelet aggregation

    30 days

Study Arms (2)

standard group

ACTIVE COMPARATOR

patients in this group received standard dual antiplatelet therapy, i.e. aspirin 300mg/d and clopidogrel 75mg/d

Drug: aspirin, clopidogrel

intensive group

EXPERIMENTAL

patients in this group received intensive antiplatelet therapy and the regimen can be adjusted according to results of platelet aggregation function test by LTA

Drug: aspirin, clopidogrel, cilostazol

Interventions

aspirin, clopidogrelDRUG

patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year

standard group
aspirin, clopidogrel, cilostazolDRUG

Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.

intensive group

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • aged 35 to 75 years
  • acute coronary syndromes
  • underwent successful coronary stent implantation
  • informed consent

You may not qualify if:

  • contraindications to antiplatelet therapy
  • history of intracranial bleeding
  • known bleeding disorders
  • severe liver or kidney disease
  • pregnancy
  • left main coronary artery disease
  • planned non cardiac surgery within 1 year
  • end stage of other serious disease with life expectancy less than 1 year
  • heart failure with NYHA grade 3 to 4

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

463 Hospital of PLA

Shenyang, Liaoning, 110000, China

Location

Shengjing Hospital of China Medical University

Shenyang, Liaoning, 110016, China

Location

Shenyang Northern Hospital

Shenyang, Liaoning, 110840, China

Location

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

AspirinClopidogrelCilostazol

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsTiclopidineThienopyridinesThiophenesSulfur CompoundsPyridinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTetrazolesAzolesQuinolines

Study Officials

  • Yaling Han, MD

    Shenyang Northern Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
vice president

Study Record Dates

First Submitted

March 26, 2010

First Posted

March 29, 2010

Study Start

March 1, 2009

Primary Completion

April 1, 2012

Study Completion

June 1, 2012

Last Updated

June 14, 2012

Record last verified: 2012-06

Locations

CN(3)