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

This study has been completed.
Information provided by (Responsible Party):
Kiyuk Chang, Seoul St. Mary's Hospital Identifier:
First received: January 7, 2013
Last updated: February 28, 2015
Last verified: February 2015
The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

Condition Intervention Phase
Coronary Artery Disease
Drug: Closone
Drug: Plavix with Astrix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:

Further study details as provided by Seoul St. Mary's Hospital:

Primary Outcome Measures:
  • Change from baseline in P2Y12% inhibition at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in VerifyNow P2Y12 reaction unit at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    PRU : VerifyNow P2Y12 reaction unit

  • Change from baseline in VerifyNow Aspirin Reaction Unit at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    ARU : VerifyNow Aspirin Reaction Unit

  • Change from baseline in maxymal platelet aggregation at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    MPA : maxymal platelet aggregation

Other Outcome Measures:
  • Adverse events [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: Yes ]

Enrollment: 91
Study Start Date: October 2012
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Closone
75mg/100mg per day, 4weeks, PO
Drug: Closone
Closone 75mg/100mg, 4weeks, PO
Active Comparator: Plavix with Astrix
Plavix 75mg with Astrix 100mg, 4weeks, PO
Drug: Plavix with Astrix
Plavix 75mg with Astrix 100mg, 4weeks, PO


Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01763749

Korea, Republic of
Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital
Seoul, Seochogu, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Principal Investigator: Ki-Bae Seung, MD, PhD Cardiovascular center and Cardiology Division, Seoul St. Mary's Hospital
  More Information

No publications provided

Responsible Party: Kiyuk Chang, Associate professor, Seoul St. Mary's Hospital Identifier: NCT01763749     History of Changes
Other Study ID Numbers: CLO_1201 
Study First Received: January 7, 2013
Last Updated: February 28, 2015
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Cardiovascular Diseases
Heart Diseases
Vascular Diseases processed this record on February 11, 2016