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

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ClinicalTrials.gov Identifier: NCT00947843
Recruitment Status : Completed
First Posted : July 28, 2009
Last Update Posted : October 13, 2016
Sponsor:
Collaborator:
CKD Pharmaceutical Limited
Information provided by (Responsible Party):
Hyo-Soo Kim, Seoul National University Hospital

Tracking Information
First Submitted Date  ICMJE July 25, 2009
First Posted Date  ICMJE July 28, 2009
Last Update Posted Date October 13, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00947843 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2009)
Adverse events after study medication [ Time Frame: 1 month ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
Official Title  ICMJE 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Coronary Heart Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Placebo Comparator: aspirin+placebo
    aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
    Intervention: Drug: aspirin + placebo
  • Active Comparator: aspirin+pregrel
    pregrel is a generic brand name of clopidogrel
    Intervention: Drug: aspirin + pregrel (Clopidogrel resinate)
  • Active Comparator: Aspirin+Plavix
    plavix is a original brand name of clopidogrel
    Intervention: Drug: aspirin + plavix (Clopidogrel bisulfate)
Publications * 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. doi: 10.1016/j.clinthera.2011.07.001. Epub 2011 Aug 4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2009)
306
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00947843
Other Study ID Numbers  ICMJE KOPRE-DM/CAD
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hyo-Soo Kim, Seoul National University Hospital
Study Sponsor  ICMJE Seoul National University Hospital
Collaborators  ICMJE CKD Pharmaceutical Limited
Investigators  ICMJE
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
PRS Account Seoul National University Hospital
Verification Date October 2016

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