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

• Status: Completed
• Trial end date: 2014-10-01
• 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: Seoul St. Mary's Hospital
• Treatments: Aspirin; Clopidogrel

Criteria

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