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

July 25, 2009
July 27, 2009
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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 ]
Same as current
Complete list of historical versions of study NCT00947843 on ClinicalTrials.gov Archive Site
Adverse events after study medication [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]
Same as current
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Assessment of the Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Coronary Heart Disease
  • Drug: aspirin + pregrel (Clopidogrel resinate)
    Other Names:
    • Aspirin: Aspirin Protect (Bayer) 100mg
    • Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg
  • Drug: aspirin + placebo
  • Drug: aspirin + plavix (Clopidogrel bisulfate)
    Other Names:
    • aspirin : Aspirin Protect (Bayer) 100mg
    • plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg
  • Placebo Comparator: aspirin+placebo
    aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
    Intervention: Drug: aspirin + placebo
  • Active Comparator: aspirin+pregrel
    Intervention: Drug: aspirin + pregrel (Clopidogrel resinate)
  • Active Comparator: Aspirin+Plavix
    Intervention: Drug: aspirin + plavix (Clopidogrel bisulfate)
Suh JW, Seung KB, Gwak CH, Kim KS, Hong SJ, Park TH, Kim SH, Choi YJ, Joo SJ, Tahk SJ, Kim HS. Comparison of antiplatelet effect and tolerability of clopidogrel Resinate with clopidogrel bisulfate in patients with coronary heart disease (CHD) or CHD-equivalent risks: a phase IV, prospective, double-dummy, parallel-group, 4-week noninferiority trial. Clin Ther. 2011 Aug;33(8):1057-68. Epub 2011 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
306
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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
Both
20 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
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NCT00947843
KOPRE-DM/CAD
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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
Seoul National University Hospital
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP