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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Coronary Heart Disease

Treatments: Drug: aspirin + placebo; Drug: aspirin + pregrel (Clopidogrel resinate); Drug: aspirin + plavix (Clopidogrel bisulfate)

Study type: Interventional

Funder types: Other

Identifiers

NCT00947843

KOPRE-DM/CAD

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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306 participants in 3 patient groups, including a placebo group

aspirin+placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: aspirin + placebo

aspirin+pregrel

Active Comparator group

Description:

pregrel is a generic brand name of clopidogrel

Treatment:

Drug: aspirin + pregrel (Clopidogrel resinate)

Aspirin+Plavix

Active Comparator group

Description:

plavix is a original brand name of clopidogrel

Treatment:

Drug: aspirin + plavix (Clopidogrel bisulfate)