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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Seoul St. Mary's Hospital
Sponsor:
Information provided by (Responsible Party):
Kiyuk Chang, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier:
NCT01763749
First received: January 7, 2013
Last updated: January 9, 2013
Last verified: January 2013
  Purpose

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 PRU at week 4 [ Time Frame: Baseline, week 4 ] [ Designated as safety issue: No ]
    PRU : VerifyNow P2Y12 reaction unit

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


Estimated Enrollment: 92
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated 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

  Eligibility

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

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 ClinicalTrials.gov identifier: NCT01763749

Contacts
Contact: Ki-Bae Seung, MD, PhD 82-2-2258-1139 kbseung@catholic.ac.kr
Contact: Kiyuk Chang, MD, PhD 82-2-2258-1139 kiyuk@catholic.ac.kr

Locations
Korea, Republic of
Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital Recruiting
Seoul, Seochogu, Korea, Republic of, 137-701
Contact: Sung Min Lim, MD    82-2-2258-1139    sungmin@catholic.ac.kr   
Principal Investigator: Ki-bae Seung, MD, PhD         
Sponsors and Collaborators
Seoul St. Mary's Hospital
Investigators
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
ClinicalTrials.gov Identifier: NCT01763749     History of Changes
Other Study ID Numbers: CLO_1201
Study First Received: January 7, 2013
Last Updated: January 9, 2013
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Clopidogrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014