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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00947843
First Posted: July 28, 2009
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
CKD Pharmaceutical Limited
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital
  Purpose
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.

Condition Intervention Phase
Coronary Heart Disease Drug: aspirin + pregrel (Clopidogrel resinate) Drug: aspirin + placebo Drug: aspirin + plavix (Clopidogrel bisulfate) Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Hyo-Soo Kim, Seoul National University Hospital:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Adverse events after study medication [ Time Frame: 1 month ]

Enrollment: 306
Study Start Date: November 2013
Study Completion Date: October 2016
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00947843


Sponsors and Collaborators
Seoul National University Hospital
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
Study Director: Seung-Jae Joo, MD,PhD Jeju National University Hospital
Study Director: Young-Jin Choi, MD,PhD Hallym University Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hyo-Soo Kim, Principal investigator, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT00947843     History of Changes
Other Study ID Numbers: KOPRE-DM/CAD
First Submitted: July 25, 2009
First Posted: July 28, 2009
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Hyo-Soo Kim, Seoul National University Hospital:
CHD
CHD equivalents

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Aspirin
Ticlopidine
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents