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

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00947843
• Other study ID #: KOPRE-DM/CAD
• Status: Completed
• Phase: Phase 4
• First received: July 25, 2009
• Last updated: October 12, 2016
• Start date: November 2013
• Est. completion date: October 2016

Study information

• Verified date: October 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 306
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Drug:
• aspirin + pregrel (Clopidogrel resinate)

• aspirin + placebo

• aspirin + plavix (Clopidogrel bisulfate)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	CKD Pharmaceutical Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Adverse events after study medication		1 month	Yes