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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00947843

Enrollment

306

Registered

2009-07-28

Start date

2013-11-30

Completion date

2016-10-31

Last updated

2016-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Heart Disease

Keywords

CHD, CHD equivalents

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.

Interventions

DRUGaspirin + pregrel (Clopidogrel resinate)

DRUGaspirin + placebo

DRUGaspirin + plavix (Clopidogrel bisulfate)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

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

Design outcomes

Primary

Measure	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

Measure	Time frame
Adverse events after study medication	1 month

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026