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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE October 18, 2008
First Posted Date  ICMJE October 21, 2008
Last Update Posted Date December 17, 2013
Study Start Date  ICMJE November 2006
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2010)
Composite of adverse cardiovascular outcomes [ Time Frame: six months ]
composite of cardiac death, myocardial infarction, ischemic stroke and target lesion revascularization
Original Primary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
Composite of adverse cardiovascular outcomes [ Time Frame: six months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2010)
  • all cause of death [ Time Frame: six months ]
  • stent thrombosis [ Time Frame: six months ]
  • each component of primary endpoint [ Time Frame: six months ]
  • PRU level [ Time Frame: at discharge after the index procedure ]
  • PRU level [ Time Frame: six months after the index procedure ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 20, 2008)
  • Albumin to creatinine ratio [ Time Frame: six months ]
  • Bleeding complications [ Time Frame: six months ]
  • P2Y12 %inhibition measured by Ultegra RFPA (VerifyNow) method [ Time Frame: six months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of CILostazol ON Ischemic Complications After DES Implantation
Official Title  ICMJE Influence of CILostazol-based Triple Anti-platelet Therapy ON Ischemic Complication After Drug-eluting stenT Implantation
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
Detailed Description Stratified randomization by statin type (rosuvastatin or atorvastatin) and the center was performed
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: cilostazol
Pletaal (Otsuka Pharm.) 100mg bid for six months
Other Name: Pletaal (Otsuka pharmaceutical)
Study Arms  ICMJE
  • Active Comparator: TAT
    triple antiplatelet therapy : aspirin, clopidogrel and cilostazol
    Intervention: Drug: cilostazol
  • Placebo Comparator: DAT
    dual antiplatelet therapy : aspirin, clopidogrel
    Intervention: Drug: cilostazol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 20, 2008)
960
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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%)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00776828
Other Study ID Numbers  ICMJE CILON-T
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyo-Soo Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Seoul National University Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP