Back to resultsKorean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
clopidogrel napadisilate + aspirin
clopidogrel bisulfate + aspirin
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring CAD, PCI, Percutaneous Coronary Intervention
Eligibility Criteria
Inclusion Criteria:
- Korean men and women between the age of 20 and 85
- Patients who were diagnosed as having CAD
- Patients who were planned to undergo PCI
Exclusion Criteria:
- Patients who were not treated with PCI or intended to treat with PCI but failed
- Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
- Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
- Patients who were had hypersensitivity to clopidogrel or aspirin
- Patients who were had abnormal laboratory results indicative of liver disease
- Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
- Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
- Patients who were had other contraindication to study drug
- Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
clopidogrel napadisilate + aspirin
clopidogrel bisulfate + aspirin
Arm Description
Outcomes
Primary Outcome Measures
The percentage of P2Y12 receptor inhibition
Secondary Outcome Measures
Adverse events after study medication
Full Information
NCT ID
NCT01584791
First Posted
April 23, 2012
Last Updated
April 24, 2012
Sponsor
Seoul National University Hospital
Collaborators
Hanmi Pharmaceutical co., ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01584791
Brief Title
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
February 2012 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Hanmi Pharmaceutical co., ltd.
4. Oversight
5. Study Description
Brief Summary
The aim of the current study is to compare the antiplatelet efficacy and safety of clopidogrel napadisilate and clopidogrel bisulfate in Coronary Artery Disease (CAD) patients after coronary stent implantation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
CAD, PCI, Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
clopidogrel napadisilate + aspirin
Arm Type
Experimental
Arm Title
clopidogrel bisulfate + aspirin
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
clopidogrel napadisilate + aspirin
Intervention Description
clopidogrel napadisilate 75mg + aspirin 100mg
Intervention Type
Drug
Intervention Name(s)
clopidogrel bisulfate + aspirin
Intervention Description
clopidogrel bisulfate 75mg + aspirin 100mg
Primary Outcome Measure Information:
Title
The percentage of P2Y12 receptor inhibition
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Adverse events after study medication
Time Frame
4 weeks
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 between the age of 20 and 85
Patients who were diagnosed as having CAD
Patients who were planned to undergo PCI
Exclusion Criteria:
Patients who were not treated with PCI or intended to treat with PCI but failed
Patients who were were taking or had taken other antiplatelet or anticoagulant for more than 2 weeks within the prior 30 days
Patients who were had a history of alcohol abuse or intoxication; (4) had hypersensitivity to clopidogrel or aspirin
Patients who were had hypersensitivity to clopidogrel or aspirin
Patients who were had abnormal laboratory results indicative of liver disease
Patients who were had blood coagulation disorders, uncontrolled severe hypertension, active bleeding, or history of severe bleeding, such as intracranial hemorrhage or ulcer bleeding
Patients who were were pregnant, breastfeeding, or not using effective methods of contraception
Patients who were had other contraindication to study drug
Patients who were had participated in another clinical study within 4 weeks prior to the start of this study
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23328268
Citation
Park JB, Koo BK, Choi WG, Kim SY, Park J, Kwan J, Park CG, Kim HS. Comparison of antiplatelet efficacy and tolerability of clopidogrel napadisilate with clopidogrel bisulfate in coronary artery disease patients after percutaneous coronary intervention: a prospective, multicenter, randomized, open-label, phase IV, noninferiority trial. Clin Ther. 2013 Jan;35(1):28-37.e4. doi: 10.1016/j.clinthera.2012.12.004.
Results Reference
derived
Learn more about this trial
Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
We'll reach out to this number within 24 hrs