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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

cilostazol

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring cilostazol, clopidogrel, statin, drug-eluting stent

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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%)

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

TAT

DAT

Arm Description

triple antiplatelet therapy : aspirin, clopidogrel and cilostazol

dual antiplatelet therapy : aspirin, clopidogrel

Outcomes

Primary Outcome Measures

Composite of adverse cardiovascular outcomes

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

Secondary Outcome Measures

all cause of death

stent thrombosis

each component of primary endpoint

PRU level

Full Information

NCT ID

NCT00776828

First Posted

October 18, 2008

Last Updated

December 15, 2013

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00776828

Brief Title

The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

Acronym

CILON-T

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

November 2006 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

cilostazol, clopidogrel, statin, drug-eluting stent

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

960 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAT

Arm Type

Active Comparator

Arm Description

triple antiplatelet therapy : aspirin, clopidogrel and cilostazol

Arm Title

DAT

Arm Type

Placebo Comparator

Arm Description

dual antiplatelet therapy : aspirin, clopidogrel

Intervention Type

Drug

Intervention Name(s)

cilostazol

Other Intervention Name(s)

Pletaal (Otsuka pharmaceutical)

Intervention Description

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

Primary Outcome Measure Information:

Title

Composite of adverse cardiovascular outcomes

Description

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

Time Frame

six months

Secondary Outcome Measure Information:

Title

all cause of death

Time Frame

six months

Title

stent thrombosis

Time Frame

six months

Title

each component of primary endpoint

Time Frame

six months

Title

PRU level

Time Frame

at discharge after the index procedure

Title

PRU level

Time Frame

six months after the index procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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%)

Overall Study Officials: