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

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HK inno.N

Status and phase

Completed
Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Plavix with Astrix
Drug: Closone

Study type

Interventional

Funder types

Industry

Identifiers

NCT01765452
CJ_CLO_401

Details and patient eligibility

About

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

Enrollment

285 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

285 participants in 2 patient groups

Closone
Experimental group
Description:
75mg/100mg per day, 8weeks, PO
Treatment:
Drug: Closone
Plavix with Astrix
Active Comparator group
Description:
75mg per day, 8weeks, PO 100mg per day, 8weeks, PO
Treatment:
Drug: Plavix with Astrix

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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