The Efficacy of CILostazol ON Ischemic Complications After DES Implantation - Full Text View

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00776828

Purpose

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

Condition	Intervention	Phase
Coronary Artery Disease	Drug: cilostazol	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease

Drug Information available for: Cilostazol Clopidogrel Clopidogrel Bisulfate

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Composite of adverse cardiovascular outcomes [ Time Frame: six months ] [ Designated as safety issue: Yes ]
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization

Secondary Outcome Measures:

all cause of death [ Time Frame: six months ] [ Designated as safety issue: No ]
stent thrombosis [ Time Frame: six months ] [ Designated as safety issue: No ]
each component of primary endpoint [ Time Frame: six months ] [ Designated as safety issue: No ]
PRU level [ Time Frame: at discharge after the index procedure ] [ Designated as safety issue: No ]
PRU level [ Time Frame: six months after the index procedure ] [ Designated as safety issue: No ]

Enrollment:	960
Study Start Date:	November 2006
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: TAT triple antiplatelet therapy : aspirin, clopidogrel and cilostazol	Drug: cilostazol Pletaal (Otsuka Pharm.) 100mg bid for six months Other Name: Pletaal (Otsuka pharmaceutical)
Placebo Comparator: DAT dual antiplatelet therapy : aspirin, clopidogrel	Drug: cilostazol Pletaal (Otsuka Pharm.) 100mg bid for six months Other Name: Pletaal (Otsuka pharmaceutical)

Detailed Description:

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

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776828

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:	Hyo-Soo Kim, MD,PhD	Seoul National University Hospital
Study Chair:	In-Ho Chae, MD, PhD	Seoul National University Bundang Hospital
Study Chair:	Jang-Ho Bae, MD, PhD	Gonyang University Hospital
Study Chair:	Myung-Chan Cho, MD, PhD	Chungbuk National University
Study Chair:	Seung-Woon Rha, MD, PhD	Korea University Guro Hospital

More Information

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Suh JW, Lee SP, Park KW, Lee HY, Kang HJ, Koo BK, Cho YS, Youn TJ, Chae IH, Choi DJ, Rha SW, Bae JH, Kwon TG, Bae JW, Cho MC, Kim HS. Multicenter randomized trial evaluating the efficacy of cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease: Results of the CILON-T (Influence of CILostazol-based triple antiplatelet therapy ON ischemic complication after drug-eluting stenT implantation) trial. J Am Coll Cardiol. 2011 Jan 18;57(3):280-9.

Lee SP, Suh JW, Park KW, Lee HY, Kang HJ, Koo BK, Chae IH, Choi DJ, Rha SW, Bae JW, Cho MC, Kwon TG, Bae JH, Kim HS; CILON-T investigators. Study design and rationale of 'Influence of Cilostazol-based triple anti-platelet therapy on ischemic complication after drug-eluting stent implantation (CILON-T)' study: A multicenter randomized trial evaluating the efficacy of Cilostazol on ischemic vascular complications after drug-eluting stent implantation for coronary heart disease. Trials. 2010 Aug 24;11:87.

Responsible Party:	Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00776828 History of Changes
Other Study ID Numbers:	CILON-T
Study First Received:	October 18, 2008
Last Updated:	March 13, 2010
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

cilostazol
clopidogrel
statin
drug-eluting stent

Additional relevant MeSH terms:

Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Clopidogrel
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents

Therapeutic Uses
Hematologic Agents
Platelet Aggregation Inhibitors
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Central Nervous System Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents

ClinicalTrials.gov processed this record on February 09, 2012