The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

NCT00776828 | Completed Phase 4 DMC

• 1 other identifier: CILON-T
• Study Type: interventional
• Target: 960
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

cilostazol; clopidogrel; statin; drug-eluting stent

Outcome Measures

Primary Outcomes (1)

• Composite of adverse cardiovascular outcomes

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

  six months

Secondary Outcomes (5)

• all cause of death

  six months

• stent thrombosis

  six months

• each component of primary endpoint

  six months

• PRU level

  at discharge after the index procedure

• PRU level

  six months after the index procedure

Study Arms (2)

TAT

ACTIVE COMPARATOR

triple antiplatelet therapy : aspirin, clopidogrel and cilostazol

Drug: cilostazol

DAT

PLACEBO COMPARATOR

dual antiplatelet therapy : aspirin, clopidogrel

Drug: cilostazol

Interventions

cilostazol DRUG

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

Also known as: Pletaal (Otsuka pharmaceutical)

DAT; TAT

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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%)

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Related Publications (3)

• 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.

  PMID: 35224730 DERIVED

• 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.

  PMID: 21232664 DERIVED

• 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.

  PMID: 20735821 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Cilostazol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Hyo-Soo Kim, MD,PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

• 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 Hospital

  STUDY CHAIR

• Seung-Woon Rha, MD, PhD

  Korea University Guro Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 18, 2008
• First Posted: October 21, 2008
• Study Start: November 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: December 17, 2013

Record last verified: 2013-12

Locations

KR (1)