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Clinical Trials/NCT00776828
NCT00776828CompletedPhase 4

Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation

Seoul National University Hospital1 site in 1 country960 target enrollmentStarted: November 2006Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
960
Locations
1
Primary Endpoint
Composite of adverse cardiovascular outcomes
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Objectives :

  • To evaluate the influence of concomitant use of cilostazol with aspirin and clopidogrel on the composite cardiovascular adverse outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) after drug-eluting stent implantation

Study Design : Prospective, open label, two arm, randomized multicenter trial to test the superiority of cilostazol group compared with the control group. Patients will be randomized according to the use of cilostazol

Patient Enrollment: 960 patients enrolled at 5 centers in Korea

Patient Follow-up : Clinical follow-up will occur at 1, 3 and 6 months. Angiographic follow-up will be recommended to all patient at 6 months after index procedure.

Primary Endpoint

  • Composite of adverse cardiovascular/cerebrovascular outcomes (cardiac death, myocardial infarction, nonhemorrhagic stroke, target lesion revascularization) within 6 months

Secondary Endpoint

  • All cause of death, stent thrombosis, and each component of primary endpoint at six months
  • PRU level measured at discharge after the index procedure and after six months

Safety Endpoint

  • Bleeding complications according to TIMI criteria
  • The incidence of drug discontinuation
  • Heart rate

Detailed Description

Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Subject must be at leat 18 years of age
  • •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of cilostazol and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
  • •Subject must have significant coronary artery stenosis (>50% by visual estimate)
  • •Subject must have evidence of myocardial ischemia (e.g., stable, unstable angina, recent infarction, silent ischemia, positive functional study or reversible changes in the electrocardiogram (ECG) consistent with ischemia. In subjects with coronary artery stenosis>75%, evidence of myocardial ischemia does not have to be documented.
  • •Coronary lesions must be amenable for percutaneous coronary revascularization with drug eluting stents.

Exclusion Criteria

  • •Subject who undergoes primary percutaneous coronary intervention due to acute ST elevation myocardial infarction
  • •Subject who has contraindication or allergy to anti-platelet agents (aspirin, clopidogrel or cilostazol)
  • •Subject who has thrombocytopenia (<120,000/uL)
  • •Subject who has liver cirrhosis (Child class B or C)
  • •Subject who is on the anticoagulation therapy
  • •Subject who has severe congestive heart failure (left ventricular ejection fraction <30%)

Arms & Interventions

TAT

Active Comparator

triple antiplatelet therapy : aspirin, clopidogrel and cilostazol

Intervention: cilostazol (Drug)

DAT

Placebo Comparator

dual antiplatelet therapy : aspirin, clopidogrel

Intervention: cilostazol (Drug)

Outcomes

Primary Outcomes

Composite of adverse cardiovascular outcomes

Time Frame: six months

composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization

Secondary Outcomes

  • all cause of death(six months)
  • stent thrombosis(six months)
  • each component of primary endpoint(six months)
  • PRU level(six months after the index procedure)

Investigators

Sponsor Class
Other

Study Sites (1)

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