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

Study Overview
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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.

Official Title
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Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents : A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Drug: aspirin + pregrel (Clopidogrel resinate)
* Drug: aspirin + placebo
* Drug: aspirin + plavix (Clopidogrel bisulfate)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: aspirin+placebo<br>aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo | Drug: aspirin + placebo<br> <br> |
| Active Comparator: aspirin+pregrel<br>pregrel is a generic brand name of clopidogrel | Drug: aspirin + pregrel (Clopidogrel resinate)<br> <br> * Other names: Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg;|
| Active Comparator: Aspirin+Plavix<br>plavix is a original brand name of clopidogrel | Drug: aspirin + plavix (Clopidogrel bisulfate)<br> <br> * Other names: plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of P2Y12 receptor inhibition assessed by Ultegra rapid platelet function analyzer, (Baseline platelet reaction unit (PRU)- posttreatment PRU)/Baseline PRU * 100 (%)) |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events after study medication |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CHD, CHD equivalents