Phase IV Study to Compare Efficacy and Safety of Plavix 75mg With Astrix 100mg and Closone

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

285 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-08-31

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, 8weeks, PO

Group Type EXPERIMENTAL

Closone

Intervention Type DRUG

75mg/100mg, 8weeks, PO

Plavix with Astrix

75mg per day, 8weeks, PO 100mg per day, 8weeks, PO

Group Type ACTIVE_COMPARATOR

Plavix with Astrix

Intervention Type DRUG

75mg, 100mg a day, 8weeks, PO

Interventions

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Closone

75mg/100mg, 8weeks, PO

Intervention Type DRUG

Plavix with Astrix

75mg, 100mg a day, 8weeks, PO

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects under a stable condition after Post-Percutaneous Coronary Artery Intervention over three months
* 20\~86 years old
* Willing to adhere to protocol requirements and sign a informed consent form

Exclusion Criteria

* Subject who did not undergo or failed Drug-Stent Implantation
* Subjects who took an anti-coagulant, anti-thrombotic regularlly( ≥ 2weeks in a month) before the study, or plan to have continuous treatment during the study(Except Aspirin alone or combination of Aspirin and Clopidogrel)
* Subjects with a history of substance or alchol abuse
* Subjects with a history of hypersensitivity to Clopidogrel, Aspirin or other NSAIDS
* Subjects having Aspirin or other NSAIDs-induced Asthma or history
* Subjects with Severe hepatopathy(AST and ALT \> 5 times the upper limit of normal)
* Subjects with Severe nephropathy(Cr \> 3 times the upper limit of normal)
* Subjects with hemorrhage like gastric ulcer, intracranial hemorrhage etc.
* Subjects with high risk of hemorrhage like blood coagulation disorders, uncontrolled severe hypertension, active bleeding, history of severe bleeding
* subjects who are pregnant, breastfeeding
* Subjects not using medically acceptable birth control
* Subjects who are unsuitable to take the Investigational product due to a medical/mental condition
* Subjects inherently having Galactose malobsorption, Lactase deficiency or Glucose-Galactose malobsorption

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No