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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: Closone; Drug: Plavix with Astrix

• Registration Number: NCT01763749
• Lead Sponsor: Seoul St. Mary's Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2013-01-07
• Study First Submitted QC: 2013-01-08
• Study First Posted: 2013-01-09
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-28
• Last Update Posted: 2015-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Closone	Closone	75mg/100mg per day, 4weeks, PO
Plavix with Astrix	Plavix with Astrix	Plavix 75mg with Astrix 100mg, 4weeks, PO

Primary Outcome Measures

Name	Time	Method
Change from baseline in P2Y12% inhibition at week 4	Baseline, week 4

Secondary Outcome Measures

Name	Time	Method
Change from baseline in VerifyNow P2Y12 reaction unit at week 4	Baseline, week 4	PRU : VerifyNow P2Y12 reaction unit
Change from baseline in maxymal platelet aggregation at week 4	Baseline, week 4	MPA : maxymal platelet aggregation
Change from baseline in VerifyNow Aspirin Reaction Unit at week 4	Baseline, week 4	ARU : VerifyNow Aspirin Reaction Unit

Trial Locations

Locations (1)

Cardiovascular Center and Cardiology Division, Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seochogu, Korea, Republic of