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Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin

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ClinicalTrials.gov Identifier: NCT01763749
Recruitment Status : Completed
First Posted : January 9, 2013
Last Update Posted : March 3, 2015
Sponsor:
Information provided by (Responsible Party):
Kiyuk Chang, Seoul St. Mary's Hospital

Tracking Information
First Submitted Date  ICMJE January 7, 2013
First Posted Date  ICMJE January 9, 2013
Last Update Posted Date March 3, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2013)
Change from baseline in P2Y12% inhibition at week 4 [ Time Frame: Baseline, week 4 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01763749 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 28, 2015)
  • Change from baseline in VerifyNow P2Y12 reaction unit at week 4 [ Time Frame: Baseline, week 4 ]
    PRU : VerifyNow P2Y12 reaction unit
  • Change from baseline in VerifyNow Aspirin Reaction Unit at week 4 [ Time Frame: Baseline, week 4 ]
    ARU : VerifyNow Aspirin Reaction Unit
  • Change from baseline in maxymal platelet aggregation at week 4 [ Time Frame: Baseline, week 4 ]
    MPA : maxymal platelet aggregation
Original Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2013)
Change from baseline in PRU, ARU at week 4 [ Time Frame: Baseline, week 4 ]
Current Other Pre-specified Outcome Measures
 (submitted: February 28, 2015)
Adverse events [ Time Frame: Baseline, week 4 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin
Official Title  ICMJE Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)
Brief Summary The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.
Detailed Description Not Provided
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: Closone
    Closone 75mg/100mg, 4weeks, PO
  • Drug: Plavix with Astrix
    Plavix 75mg with Astrix 100mg, 4weeks, PO
Study Arms  ICMJE
  • Experimental: Closone
    75mg/100mg per day, 4weeks, PO
    Intervention: Drug: Closone
  • Active Comparator: Plavix with Astrix
    Plavix 75mg with Astrix 100mg, 4weeks, PO
    Intervention: Drug: Plavix with Astrix
Publications * Not Provided

*   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: February 28, 2015)
91
Original Estimated Enrollment  ICMJE
 (submitted: January 8, 2013)
92
Actual Study Completion Date  ICMJE October 2014
Actual Primary Completion Date October 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects under condition after Post-Percutaneous Coronary Artery Intervention over twelve months
  • 20~85 years old
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria:

  • Subject who did not undergo or failed Stent Implantation
  • Subjects who took an anti-coagulant, anti-thrombotic regularly before the study, or plan to have continuous treatment during the study
  • Subjects with a history of hypersensitivity to Clopidogrel, Aspirin
  • Subjects with uncontrolled severe hypertension
  • Subjects with high risk of hemorrhage like blood coagulation disorders

    :gastrointestinal bleeding, gross hematuria, intraocular bleeding, hemorrhagic stroke, intracranial hemorrhage

  • Subjects with intractable arrhythmia, intracranial hemorrhage
  • Subjects with Severe cardiomyopathy (New York Heart Association(NYHA) Class Ⅳ)
  • Subjects with Severe hepatopathy(AST and ALT > 10 times the upper limit of normal)
  • Subjects who are pregnant, breastfeeding and not using medically acceptable birth control
  • Subjects considered as unsuitable based on medical judgement by investigators
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 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 NCT01763749
Other Study ID Numbers  ICMJE CLO_1201
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kiyuk Chang, Seoul St. Mary's Hospital
Study Sponsor  ICMJE Seoul St. Mary's Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ki-Bae Seung, MD, PhD Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital
PRS Account Seoul St. Mary's Hospital
Verification Date February 2015

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