Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents

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

306 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to compare the efficacy and tolerability between clopidogrel resinate and clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD equivalents.

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Detailed Description

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Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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aspirin+placebo

aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo

Group Type PLACEBO_COMPARATOR

aspirin + placebo

Intervention Type DRUG

aspirin+pregrel

pregrel is a generic brand name of clopidogrel

Group Type ACTIVE_COMPARATOR

aspirin + pregrel (Clopidogrel resinate)

Intervention Type DRUG

Aspirin+Plavix

plavix is a original brand name of clopidogrel

Group Type ACTIVE_COMPARATOR

aspirin + plavix (Clopidogrel bisulfate)

Intervention Type DRUG

Interventions

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aspirin + pregrel (Clopidogrel resinate)

Intervention Type DRUG

aspirin + placebo

Intervention Type DRUG

aspirin + plavix (Clopidogrel bisulfate)

Intervention Type DRUG

Other Intervention Names

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Aspirin: Aspirin Protect (Bayer) 100mg Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg aspirin : Aspirin Protect (Bayer) 100mg plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg

Eligibility Criteria

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Inclusion Criteria

* Korean men and women aged 20 to 85 years with coronary heart disease (CHD) or CHD equivalent patients
* Atherosclerotic plaques in coronary computed tomography (CT) or angiography or
* History of PCI or coronary artery bypass graft surgery (CABG) \> one year or
* Diabetes mellitus (including type I and type II) or
* Confirmed carotid atherosclerotic plaque with sonography, CT or angiography or
* History of peripheral artery disease or
* History of cerebrovascular disease

Exclusion Criteria

* Patients who had history of PCI within one year
* Patients who used concomitant anticoagulants
* Patients who had hypersensitivity to aspirin or clopidogrel, serious bleeding tendency, history of intracranial hemorrhage, sign of active bleeding, uncontrolled hypertension
* Chronic alcoholism or drug addiction
* Women who were pregnant or breastfeeding or who were not using an effective method of contraception
* The use of glycoprotein IIb/IIIa inhibitor, daily NSAIDs, lipid lowering agent (except atorvastatin), or substances with possible interactions with the study drug

Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No