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

Phase 4

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: clopidogrel napadisilate + aspirin; Drug: clopidogrel bisulfate + aspirin

• Registration Number: NCT01584791
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2012-02
• Status Verified: 2012-04
• Study First Submitted: 2012-04-23
• Study First Submitted QC: 2012-04-24
• Last Update Submitted: 2012-04-24
• Study First Posted: 2012-04-25
• Last Update Posted: 2012-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 148

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clopidogrel napadisilate + aspirin	clopidogrel napadisilate + aspirin	-
clopidogrel bisulfate + aspirin	clopidogrel bisulfate + aspirin	-

Primary Outcome Measures

Name	Time	Method
The percentage of P2Y12 receptor inhibition	4 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events after study medication	4 weeks

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of