Text Size

Assessment of the 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:
Collaborator:
CKD Pharmaceutical Limited
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT00947843
First received: July 25, 2009
Last updated: July 27, 2009
Last verified: July 2009
History of Changes
  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
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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 306
Arms Assigned Interventions
Placebo Comparator: aspirin+placebo
aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
 Drug: aspirin + placebo
Active Comparator: aspirin+pregrel Drug: aspirin + pregrel (Clopidogrel resinate)
Other Names:
  • Aspirin: Aspirin Protect (Bayer) 100mg
  • Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg
Active Comparator: Aspirin+Plavix Drug: aspirin + plavix (Clopidogrel bisulfate)
Other Names:
  • aspirin : Aspirin Protect (Bayer) 100mg
  • plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00947843     History of Changes
Other Study ID Numbers: KOPRE-DM/CAD
Study First Received: July 25, 2009
Last Updated: July 27, 2009
Health Authority: South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Seoul National University Hospital:
CHD
CHD equivalents

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

ClinicalTrials.gov processed this record on June 18, 2013