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

• Status: Completed
• Trial end date: 2013-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CJ HealthCare Corporation; HK inno.N Corporation
• Treatments: Clopidogrel

Criteria

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