The Efficacy of CILostazol ON Ischemic Complications After DES Implantation - Full Text View

Sponsor:	Seoul National University Hospital
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00776828

Purpose

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.

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
P2Y12 reaction unit (PRU) value at six months

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 infarction
Bleeding complication
Angiographic outcome (late loss, binary restenosis)

Condition	Intervention	Phase
Coronary Artery Disease	Drug: cilostazol Drug: atorvastatin Drug: rosuvastatin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation

Resource links provided by NLM:

MedlinePlus related topics: Coronary Artery Disease Statins

Drug Information available for: Cilostazol Atorvastatin Atorvastatin calcium Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Composite of adverse cardiovascular outcomes [ Time Frame: six months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Albumin to creatinine ratio [ Time Frame: six months ] [ Designated as safety issue: No ]
Bleeding complications [ Time Frame: six months ] [ Designated as safety issue: Yes ]
P2Y12 %inhibition measured by Ultegra RFPA (VerifyNow) method [ Time Frame: six months ] [ Designated as safety issue: No ]

Enrollment:	976
Study Start Date:	November 2006
Study Completion Date:	January 2010
Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
CR: Active Comparator cilostazol, rosuvastatin	Drug: cilostazol cilostazol100mg twice per day for six months Drug: rosuvastatin rosuvastatin 10mg per day for six months
CoA: Experimental Control, atorvastatin	Drug: atorvastatin atorvastatin 20mg per day for six months
CoR: Active Comparator Control, rosuvastatin	Drug: rosuvastatin rosuvastatin 10mg per day for six months
CA: Experimental cilostazol, atorvastatin	Drug: cilostazol cilostazol100mg twice per day for six months Drug: atorvastatin atorvastatin 20mg per day for six months

Detailed Description:

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Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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%)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00776828

Locations

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

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator:	Hyo-Soo Kim, MD,PhD	Seoul National University Hospital
Study Chair:	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
Study Chair:	Seung-Woon Rha, MD, PhD	Korea University Guro Hospital

More Information

No publications provided

Responsible Party:	Seoul National University Hospital ( Hyo-Soo Kim )
Study ID Numbers:	CILON-T
Study First Received:	October 18, 2008
Last Updated:	January 20, 2010
ClinicalTrials.gov Identifier:	NCT00776828 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:

cilostazol
clopidogrel
statin
drug-eluting stent

Additional relevant MeSH terms:

Antimetabolites
Respiratory System Agents
Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Myocardial Ischemia
Physiological Effects of Drugs
Hematologic Agents
Fibrinolytic Agents
Arteriosclerosis
Neuroprotective Agents
Fibrin Modulating Agents
Rosuvastatin
Therapeutic Uses
Cardiovascular Diseases
Arterial Occlusive Diseases

Cilostazol
Heart Diseases
Antilipemic Agents
Vascular Diseases
Anti-Asthmatic Agents
Enzyme Inhibitors
Anticholesteremic Agents
Cardiovascular Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Protective Agents
Pharmacologic Actions
Coronary Disease
Phosphodiesterase Inhibitors
Autonomic Agents
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010