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The Efficacy of CILostazol ON Ischemic Complications After DES Implantation

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: cilostazol (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

Official(s) and/or principal investigator(s):
Hyo-Soo Kim, MD,PhD, Principal Investigator, Affiliation: Seoul National University Hospital
In-Ho Chae, MD, PhD, Study Chair, Affiliation: Seoul National University Bundang Hospital
Jang-Ho Bae, MD, PhD, Study Chair, Affiliation: Gonyang University Hospital
Myung-Chan Cho, MD, PhD, Study Chair, Affiliation: Chungbuk National University Hospital
Seung-Woon Rha, MD, PhD, Study Chair, Affiliation: Korea University Guro Hospital

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

Clinical Details

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

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

Primary outcome: Composite of adverse cardiovascular outcomes

Secondary outcome:

all cause of death

stent thrombosis

each component of primary endpoint

PRU level

PRU level

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

Eligibility

Minimum age: 18 Years. Maximum age: 80 Years. Gender(s): Both.

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%)

Locations and Contacts

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

Starting date: November 2006
Last updated: December 15, 2013

Page last updated: August 23, 2015

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