The Efficacy of CILostazol ON Thrombotic Complications After DES Implantation

Condition(s) targeted: Coronary Artery Disease

Intervention: cilostazol (Drug); atorvastatin (Drug); rosuvastatin (Drug)

Phase: Phase 4

Status: Recruiting

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

Overall contact:
Jung-Won Suh, MD, PhD, Phone: 82-31-787-7016, Email: 65411@snubh.org

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

- To evaluate the statin-clopidogrel interaction according to statin type by head-to-head

comparison of two types of statin (atorvastatin vs. rosuvastatin)

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 in an two by two factorial manner according to the use of cilostazol and the type of statin. Randomized will also be stratified per hospital for the use of celecoxib.

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 occur at 6 months.

Primary Endpoint

- Composite cardiovascular adverse outcomes (cardiac death, myocardial infarction,

nonhemorrhagic stroke, target lesion revascularization) within 6 months

- P2Y12 reaction unit (PRU) value at six months for comparison of atorvastatin vs.

rosuvastatin group.

Secondary Endpoint

- The incidence of contrast-induced nephropathy in high risk group

- Baseline and six months albumin to creatinine ratio (ACR)

- The incidence of periprocedural infraction

- Bleeding complication

- Angiographic outcome (late loss, binary restenosis)

Official title: The Influence of Cilostazol-Based Triple Antiplatelet Therapy on Thrombotic Complications After Drug-Eluting Stent Implantation

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Composite of adverse cardiovascular outcomes

Secondary outcome:

Albumin to creatinine ratio

Bleeding complications

P2Y12 %inhibition measured by Ultegra RFPA (VerifyNow) method

Detailed description: .

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.

- Subject must have drug-eluting stent for revascularization.

Exclusion Criteria:

- Subject who undergoes primary percutaneous coronary intervention due to acute ST

elevation myocardial infarction

- Subject who has contraindication or allergy to antiplatelet 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%)

Jung-Won Suh, MD, PhD, Phone: 82-31-787-7016, Email: 65411@snubh.org

Seoul National University Hospital, Seoul 110-744, Korea, Republic of; Recruiting
Jung-Won Suh, MD, PhD, Phone: 82-31-787-7016, Email: 65411@snubh.org
Hyo-Soo Kim, MD. PhD, Phone: 82-2-2072-2226, Email: hyosoo@snu.ac.kr

Starting date: November 2006
Ending date: September 2009
Last updated: October 20, 2008