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Completed

NCT Number: NCT01763749

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

The Aim of this study is to prove non-inferiority of Closone to the Combination treatment of Plavix with Astrix.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital

Seoul, Seochogu, 137-701, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closone

Drug

Closone 75mg/100mg, 4weeks, PO

Plavix with Astrix

Drug

Plavix 75mg with Astrix 100mg, 4weeks, PO

Primary outcomes

  1. Change from baseline in P2Y12% inhibition at week 4

    Time frame: Baseline, week 4

Secondary outcomes

  1. Change from baseline in VerifyNow P2Y12 reaction unit at week 4

    Time frame: Baseline, week 4

    PRU : VerifyNow P2Y12 reaction unit

  2. Change from baseline in VerifyNow Aspirin Reaction Unit at week 4

    Time frame: Baseline, week 4

    ARU : VerifyNow Aspirin Reaction Unit

  3. Change from baseline in maxymal platelet aggregation at week 4

    Time frame: Baseline, week 4

    MPA : maxymal platelet aggregation

Other outcomes

  1. Adverse events

    Time frame: Baseline, week 4

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study 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)

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 9, 2013
Registry last updated
Mar 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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