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

Phase 4

Completed

• Conditions: Coronary Heart Disease
• Interventions: Drug: aspirin + placebo; Drug: aspirin + pregrel (Clopidogrel resinate); Drug: aspirin + plavix (Clopidogrel bisulfate)

• Registration Number: NCT00947843
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-25
• Study First Submitted QC: 2009-07-27
• Study First Posted: 2009-07-28
• Study Start: 2013-11
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin+placebo	aspirin + placebo	aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
aspirin+pregrel	aspirin + pregrel (Clopidogrel resinate)	pregrel is a generic brand name of clopidogrel
Aspirin+Plavix	aspirin + plavix (Clopidogrel bisulfate)	plavix is a original brand name of clopidogrel

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Adverse events after study medication	1 month