Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting
NCT ID: NCT01584791
Last Updated: 2012-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
148 participants
INTERVENTIONAL
2010-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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clopidogrel napadisilate + aspirin
clopidogrel napadisilate + aspirin
clopidogrel napadisilate 75mg + aspirin 100mg
clopidogrel bisulfate + aspirin
clopidogrel bisulfate + aspirin
clopidogrel bisulfate 75mg + aspirin 100mg
Interventions
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clopidogrel napadisilate + aspirin
clopidogrel napadisilate 75mg + aspirin 100mg
clopidogrel bisulfate + aspirin
clopidogrel bisulfate 75mg + aspirin 100mg
Eligibility Criteria
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Inclusion Criteria
* Patients who were diagnosed as having CAD
* Patients who were planned to undergo PCI
Exclusion Criteria
* 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
20 Years
85 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical co., ltd.
OTHER
Seoul National University Hospital
OTHER
Responsible Party
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Hyo-Soo Kim
Professor, Department of Internal Medicine, Seoul National University Hospital
Locations
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Seoul National University Hospital
Seoul, , South Korea
Countries
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References
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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.
Other Identifiers
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KOPIDO STENT
Identifier Type: -
Identifier Source: org_study_id
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