Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
aspirin + pregrel (Clopidogrel resinate)
aspirin + placebo
aspirin + plavix (Clopidogrel bisulfate)
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring CHD, CHD equivalents
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
aspirin+placebo
aspirin+pregrel
Aspirin+Plavix
Arm Description
aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
pregrel is a generic brand name of clopidogrel
plavix is a original brand name of clopidogrel
Outcomes
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 (%))
Secondary Outcome Measures
Adverse events after study medication
Full Information
NCT ID
NCT00947843
First Posted
July 25, 2009
Last Updated
October 12, 2016
Sponsor
Seoul National University Hospital
Collaborators
CKD Pharmaceutical Limited
1. Study Identification
Unique Protocol Identification Number
NCT00947843
Brief Title
Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
October 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
CKD Pharmaceutical Limited
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
CHD, CHD equivalents
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
306 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aspirin+placebo
Arm Type
Placebo Comparator
Arm Description
aspirin protect (Bayer) 100mg + placebo clopidogrel 75mg for 1mo
Arm Title
aspirin+pregrel
Arm Type
Active Comparator
Arm Description
pregrel is a generic brand name of clopidogrel
Arm Title
Aspirin+Plavix
Arm Type
Active Comparator
Arm Description
plavix is a original brand name of clopidogrel
Intervention Type
Drug
Intervention Name(s)
aspirin + pregrel (Clopidogrel resinate)
Other Intervention Name(s)
Aspirin: Aspirin Protect (Bayer) 100mg, Pregrel: Clopidogrel resinate (CKD Pharmaceutical) 75mg
Intervention Type
Drug
Intervention Name(s)
aspirin + placebo
Intervention Type
Drug
Intervention Name(s)
aspirin + plavix (Clopidogrel bisulfate)
Other Intervention Name(s)
aspirin : Aspirin Protect (Bayer) 100mg, plavix : Clopidogrel bisulfate (Sanofi-Aventis) 75mg
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Adverse events after study medication
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ki-Bae Seung, MD, PhD
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chung-Hwan Gwak, MD, PhD
Organizational Affiliation
Gyeongsang National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Kwon-Sam Kim, MD,PhD
Organizational Affiliation
Kyung Hee University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Soon-Jun Hong, MD,PhD
Organizational Affiliation
Korea University Anam Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tae-Ho Park, MD,PhD
Organizational Affiliation
Dong-A medical center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Kim, MD,PhD
Organizational Affiliation
Seoul Metropolitan Boramae Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seung-Jea Tahk, MD,PhD
Organizational Affiliation
Ajou University Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Seung-Jae Joo, MD,PhD
Organizational Affiliation
Jeju National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Young-Jin Choi, MD,PhD
Organizational Affiliation
Hallym University Medical Center
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
21816478
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Tolerability of Clopidogrel Resinate and Clopidogrel Bisulfate in Patients With Coronary Heart Disease (CHD) or CHD Equivalents
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