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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 09, 2015