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

Seoul St. Mary's Hospital

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: Plavix with Astrix

Drug: Closone

Study type

Interventional

Funder types

Other

Identifiers

CLO_1201

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

91 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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