Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 coronary-artery-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedFirst Posted
Study publicly available on registry
April 25, 2012
CompletedApril 25, 2012
April 1, 2012
1.3 years
April 23, 2012
April 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The percentage of P2Y12 receptor inhibition
4 weeks
Secondary Outcomes (1)
Adverse events after study medication
4 weeks
Study Arms (2)
clopidogrel napadisilate + aspirin
EXPERIMENTALclopidogrel bisulfate + aspirin
ACTIVE COMPARATORInterventions
clopidogrel napadisilate 75mg + aspirin 100mg
clopidogrel bisulfate 75mg + aspirin 100mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Hanmi Pharmaceutical co., ltd.collaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 110-744, South Korea
Related Publications (1)
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.
PMID: 23328268DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Department of Internal Medicine, Seoul National University Hospital
Study Record Dates
First Submitted
April 23, 2012
First Posted
April 25, 2012
Study Start
October 1, 2010
Primary Completion
February 1, 2012
Last Updated
April 25, 2012
Record last verified: 2012-04