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The Efficacy of CILostazol ON Ischemic Complications After DES Implantation (CILON-T)

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ClinicalTrials.gov Identifier: NCT00776828
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : December 17, 2013
Sponsor:
Information provided by:
Seoul National University Hospital

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

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Drug: cilostazol Phase 4

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 960 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
Study Start Date : November 2006
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Cilostazol

Arm Intervention/treatment
Active Comparator: TAT
triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
Drug: cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Name: Pletaal (Otsuka pharmaceutical)

Placebo Comparator: DAT
dual antiplatelet therapy : aspirin, clopidogrel
Drug: cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Name: Pletaal (Otsuka pharmaceutical)




Primary Outcome Measures :
  1. Composite of adverse cardiovascular outcomes [ Time Frame: six months ]
    composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization


Secondary Outcome Measures :
  1. all cause of death [ Time Frame: six months ]
  2. stent thrombosis [ Time Frame: six months ]
  3. each component of primary endpoint [ Time Frame: six months ]
  4. PRU level [ Time Frame: at discharge after the index procedure ]
  5. PRU level [ Time Frame: six months after the index procedure ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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%)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776828


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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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 Hospital
Study Chair: Seung-Woon Rha, MD, PhD Korea University Guro Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hyo-Soo Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00776828     History of Changes
Other Study ID Numbers: CILON-T
First Posted: October 21, 2008    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013
Keywords provided by Seoul National University Hospital:
cilostazol
clopidogrel
statin
drug-eluting stent
Additional relevant MeSH terms:
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Myocardial Ischemia
Clopidogrel
Coronary Artery Disease
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cilostazol
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Vasodilator Agents
Neuroprotective Agents
Protective Agents
Phosphodiesterase 3 Inhibitors
Phosphodiesterase Inhibitors