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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01584791
• Other study ID #: KOPIDO STENT
• Status: Completed
• Phase: Phase 4
• First received: April 23, 2012
• Last updated: April 24, 2012
• Start date: October 2010

Study information

• Verified date: April 2012
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review BoardSouth Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• clopidogrel napadisilate + aspirin
clopidogrel napadisilate 75mg + aspirin 100mg
• clopidogrel bisulfate + aspirin
clopidogrel bisulfate 75mg + aspirin 100mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Hanmi Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of P2Y12 receptor inhibition		4 weeks	No
Secondary	Adverse events after study medication		4 weeks	Yes