Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
CKD Pharmaceutical Limited
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital Identifier:
First received: July 25, 2009
Last updated: October 12, 2016
Last verified: October 2016
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events after study medication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

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


Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00947843

Sponsors and Collaborators
Seoul National University Hospital
CKD Pharmaceutical Limited
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 Identifier (NCT Number):
Responsible Party: Hyo-Soo Kim, Principal investigator, Seoul National University Hospital Identifier: NCT00947843     History of Changes
Other Study ID Numbers: KOPRE-DM/CAD 
Study First Received: July 25, 2009
Last Updated: October 12, 2016
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
CHD equivalents

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents processed this record on October 21, 2016