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Completed

NCT Number: NCT00776828

The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

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

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%)

Treatment and study plan

Cilostazol

Drug

Pletaal (Otsuka Pharm.) 100mg bid for six months

Other names: Pletaal (Otsuka pharmaceutical)

Primary outcomes

  1. Composite of adverse cardiovascular outcomes

    Time frame: six months

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

Secondary outcomes

  1. all cause of death

    Time frame: six months

  2. stent thrombosis

    Time frame: six months

  3. each component of primary endpoint

    Time frame: six months

  4. PRU level

    Time frame: at discharge after the index procedure

  5. PRU level

    Time frame: six months after the index procedure

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: CILON-T

Important dates

Study start
2006
Primary completion
2010
Study completion
2010
First posted
Oct 21, 2008
Registry last updated
Dec 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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