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

October 12, 2016 updated by: Hyo-Soo Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

306

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: aspirin+placebo
aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
Drug: aspirin + placebo
ACTIVE_COMPARATOR: aspirin+pregrel
pregrel is a generic brand name of clopidogrel
Drug: aspirin + pregrel (Clopidogrel resinate)
Other Names:
  • Aspirin: Aspirin Protect (Bayer) 100mg
  • Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg
ACTIVE_COMPARATOR: Aspirin+Plavix
plavix is a original brand name of clopidogrel
Drug: aspirin + plavix (Clopidogrel bisulfate)
Other Names:
  • aspirin : Aspirin Protect (Bayer) 100mg
  • plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg

What is the study measuring?

Primary Outcome Measures

Outcome 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 (%))
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events after study medication
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

CKD Pharmaceutical Limited

Investigators

  • Study Director: Ki-Bae Seung, MD, PhD, Seoul St. Mary's Hospital
  • Study Director: Chung-Hwan Gwak, MD, PhD, Gyeongsang National University Hospital
  • Study Director: Kwon-Sam Kim, MD,PhD, Kyung Hee University Hospital
  • Study Director: Soon-Jun Hong, MD,PhD, Korea University Anam Hospital
  • Study Director: Tae-Ho Park, MD,PhD, Dong-A Medical Center
  • Study Director: Sang-Hyun Kim, MD,PhD, Seoul Metropolitan Boramae Hospital
  • Study Director: Seung-Jea Tahk, MD,PhD, Ajou University Medical Center
  • Study Director: Seung-Jae Joo, MD,PhD, Jeju National University Hospital
  • Study Director: Young-Jin Choi, MD,PhD, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 1, 2016

Study Registration Dates

First Submitted

July 25, 2009

First Submitted That Met QC Criteria

July 27, 2009

First Posted (ESTIMATE)

July 28, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

October 13, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOPRE-DM/CAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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