Overview

Korean Multicenter Randomized Controlled Trial (RCT) of Pidogul for Patients With Coronary Stenting

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Seoul National University Hospital
Collaborator:
Hanmi Pharmaceutical co., ltd.
Treatments:
Aspirin
Clopidogrel
Ticlopidine
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