The Efficacy of CILostazol ON Ischemic Complications After DES Implantation (CILON-T)

December 15, 2013 updated by: Seoul National University Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

960

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: TAT
triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
Drug: cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Names:
  • Pletaal (Otsuka pharmaceutical)
PLACEBO_COMPARATOR: DAT
dual antiplatelet therapy : aspirin, clopidogrel
Drug: cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Names:
  • Pletaal (Otsuka pharmaceutical)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite of adverse cardiovascular outcomes
Time Frame: six months
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
six months

Secondary Outcome Measures

Outcome Measure
Time Frame
all cause of death
Time Frame: six months
six months
stent thrombosis
Time Frame: six months
six months
each component of primary endpoint
Time Frame: six months
six months
PRU level
Time Frame: at discharge after the index procedure
at discharge after the index procedure
PRU level
Time Frame: six months after the index procedure
six months after the index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Chair: Jang-Ho Bae, MD, PhD, Gonyang University Hospital
  • Study Chair: Myung-Chan Cho, MD, PhD, Chungbuk National University Hospital
  • Study Chair: Seung-Woon Rha, MD, PhD, Korea University Guro Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

October 18, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (ESTIMATE)

October 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 17, 2013

Last Update Submitted That Met QC Criteria

December 15, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CILON-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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