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

Seoul National University

Status and phase

Completed

Phase 4

Conditions

Coronary Artery Disease

Treatments

Drug: clopidogrel napadisilate + aspirin

Drug: clopidogrel bisulfate + aspirin

Study type

Interventional

Funder types

Other

Identifiers

NCT01584791

KOPIDO STENT

Details and patient eligibility

About

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.

Enrollment

148 patients

Sex

All

Ages

20 to 85 years old

Volunteers

No Healthy Volunteers

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