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

• Status: Completed
• Trial end date: 2016-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Seoul National University Hospital
• Collaborator: CKD Pharmaceutical Limited
• Treatments: Aspirin; Clopidogrel; Ticlopidine

Criteria

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