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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01584791

Enrollment

148

Registered

2012-04-25

Start date

2010-10-31

Completion date

Unknown

Last updated

2012-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

CAD, PCI, Percutaneous Coronary Intervention

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.

Interventions

DRUGclopidogrel napadisilate + aspirin

clopidogrel napadisilate 75mg + aspirin 100mg

DRUGclopidogrel bisulfate + aspirin

clopidogrel bisulfate 75mg + aspirin 100mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The percentage of P2Y12 receptor inhibition	4 weeks

Secondary

Measure	Time frame
Adverse events after study medication	4 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026