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

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

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