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

NCT ID: NCT01584791

Last Updated: 2012-04-25

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Brief Summary

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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

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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clopidogrel napadisilate + aspirin

Group Type EXPERIMENTAL

clopidogrel napadisilate + aspirin

Intervention Type DRUG

clopidogrel napadisilate 75mg + aspirin 100mg

clopidogrel bisulfate + aspirin

Group Type ACTIVE_COMPARATOR

clopidogrel bisulfate + aspirin

Intervention Type DRUG

clopidogrel bisulfate 75mg + aspirin 100mg

Interventions

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clopidogrel napadisilate + aspirin

clopidogrel napadisilate 75mg + aspirin 100mg

Intervention Type DRUG

clopidogrel bisulfate + aspirin

clopidogrel bisulfate 75mg + aspirin 100mg

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hanmi Pharmaceutical co., ltd.

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Soo Kim

Professor, Department of Internal Medicine, Seoul National University Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

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.

Reference Type DERIVED
PMID: 23328268 (View on PubMed)

Other Identifiers

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KOPIDO STENT

Identifier Type: -

Identifier Source: org_study_id

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