The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

Coronary Artery Disease Clinical Trial

— CILON-T  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776828
• Other study ID #: CILON-T
• Status: Completed
• Phase: Phase 4
• First received: October 18, 2008
• Last updated: December 15, 2013
• Start date: November 2006
• Est. completion date: January 2010

Study information

• Verified date: December 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 960
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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%)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of adverse cardiovascular outcomes	composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization	six months	Yes
Secondary	all cause of death		six months	No
Secondary	stent thrombosis		six months	No
Secondary	each component of primary endpoint		six months	No
Secondary	PRU level		at discharge after the index procedure	No
Secondary	PRU level		six months after the index procedure	No