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

Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Coronary Artery Disease

Intervention: clopidogrel napadisilate + aspirin (Drug); clopidogrel bisulfate + aspirin (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Seoul National University Hospital

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.

Clinical Details

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The percentage of P2Y12 receptor inhibition

Secondary outcome: Adverse events after study medication

Eligibility

Minimum age: 20 Years. Maximum age: 85 Years. Gender(s): Both.

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

Locations and Contacts

Seoul National University Hospital, Seoul 110-744, Korea, Republic of
Additional Information

Starting date: October 2010
Last updated: April 24, 2012

Page last updated: August 23, 2015

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