The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
NCT ID: NCT00776828
Last Updated: 2013-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
960 participants
INTERVENTIONAL
2006-11-30
2010-01-31
Brief Summary
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* 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
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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TAT
triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
DAT
dual antiplatelet therapy : aspirin, clopidogrel
cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Interventions
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cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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%)
18 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Seoul National University Hospital
Principal Investigators
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Hyo-Soo Kim, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
In-Ho Chae, MD, PhD
Role: STUDY_CHAIR
Seoul National University Bundang Hospital
Jang-Ho Bae, MD, PhD
Role: STUDY_CHAIR
Gonyang University Hospital
Myung-Chan Cho, MD, PhD
Role: STUDY_CHAIR
Chungbuk National University Hospital
Seung-Woon Rha, MD, PhD
Role: STUDY_CHAIR
Korea University Guro Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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Natale P, Palmer SC, Saglimbene VM, Ruospo M, Razavian M, Craig JC, Jardine MJ, Webster AC, Strippoli GF. Antiplatelet agents for chronic kidney disease. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD008834. doi: 10.1002/14651858.CD008834.pub4.
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. doi: 10.1016/j.jacc.2010.08.631.
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. doi: 10.1186/1745-6215-11-87.
Other Identifiers
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CILON-T
Identifier Type: -
Identifier Source: org_study_id