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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-10-31

Brief Summary

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

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Closone

75mg/100mg per day, 4weeks, PO

Group Type EXPERIMENTAL

Closone

Intervention Type DRUG

Closone 75mg/100mg, 4weeks, PO

Plavix with Astrix

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

Group Type ACTIVE_COMPARATOR

Plavix with Astrix

Intervention Type DRUG

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

Interventions

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Closone

Closone 75mg/100mg, 4weeks, PO

Intervention Type DRUG

Plavix with Astrix

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No