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OpenTrials
Completed

NCT Number: NCT01765452

Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

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

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inje university haeundae paik hospital, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
  • 20~86 years old
  • Willing to adhere to protocol requirements and sign a informed consent form

Exclusion criteria

  • Subject who did not undergo or failed Drug-Stent Implantation
  • Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
  • Subjects with a history of substance or alchol abuse
  • Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
  • Subjects having Aspirin or other NSAIDs-induced Asthma or history
  • Subjects with Severe hepatopathy(AST and ALT > 5 times the upper limit of normal)
  • Subjects with Severe nephropathy(Cr > 3 times the upper limit of normal)
  • Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
  • Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
  • subjects who are pregnant, breastfeeding
  • Subjects not using medically acceptable birth control
  • Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
  • Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption

Treatment and study plan

Closone

Drug

75mg/100mg, 8weeks, PO

Plavix with Astrix

Drug

75mg, 100mg a day, 8weeks, PO

Primary outcomes

  1. Change from baselinine in P2Y12% inhibition at week 8

    Time frame: Baseline, week 8

Secondary outcomes

  1. Change from baseline in PRU, ARU at week 8

    Time frame: Baseline, week 8

Sponsors and collaborators

Lead sponsor

HK inno.N Corporation

Industry

Registry information

Official study title

Multi-center, Randomized, Open Study for Comparison of Efficacy and Safety of Plavix With Astrix and Closone in Patients With Post-Percutaneous Coronary Artery Intervention

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 10, 2013
Registry last updated
May 12, 2014

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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