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

April 24, 2012 updated by: Hyo-Soo Kim, Seoul National University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: clopidogrel napadisilate + aspirin
Drug: clopidogrel napadisilate + aspirin
clopidogrel napadisilate 75mg + aspirin 100mg
Active Comparator: clopidogrel bisulfate + aspirin
Drug: clopidogrel bisulfate + aspirin
clopidogrel bisulfate 75mg + aspirin 100mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The percentage of P2Y12 receptor inhibition
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events after study medication
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Hanmi Pharmaceutical co., ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

April 24, 2012

First Posted (Estimate)

April 25, 2012

Study Record Updates

Last Update Posted (Estimate)

April 25, 2012

Last Update Submitted That Met QC Criteria

April 24, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KOPIDO STENT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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