Clinical trial NCT00776828: The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
Official title: Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: cilostazol
clopidogrel
statin
drug-eluting stent
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-10-21
Enrollment: 960
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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%)

Primary outcomes:
measure: Composite of adverse cardiovascular outcomes
timeFrame: six months
Secondary outcomes:
measure: all cause of death
timeFrame: six months
measure: stent thrombosis
timeFrame: six months
measure: each component of primary endpoint
timeFrame: six months
measure: PRU level
timeFrame: at discharge after the index procedure
measure: PRU level
timeFrame: six months after the index procedure
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul National University Bundang Hospital
name: In-Ho Chae, MD, PhD
role: STUDY_CHAIR
affiliation: Gonyang University Hospital
name: Jang-Ho Bae, MD, PhD
role: STUDY_CHAIR
affiliation: Chungbuk National University Hospital
name: Myung-Chan Cho, MD, PhD
role: STUDY_CHAIR
affiliation: Korea University Guro Hospital
name: Seung-Woon Rha, MD, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.