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

Comparison of the Efficacy and Safety of Closone and Clopidogrel With Aspirin in Korean Patients With Coronary Artery Disease (a Single-center, Randomized, Open-label Clinical Trial)

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01763749

Enrollment

Registered

2013-01-09

Start date

2012-10-31

Completion date

2014-10-31

Last updated

2015-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Brief summary

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

Interventions

DRUGClosone

Closone 75mg/100mg, 4weeks, PO

DRUGPlavix with Astrix

Plavix 75mg with Astrix 100mg, 4weeks, PO

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Change from baseline in P2Y12% inhibition at week 4	Baseline, week 4

Secondary

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

Other

Measure	Time frame
Adverse events	Baseline, week 4

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026