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Completed

NCT Number: NCT01584791

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

20 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clopidogrel napadisilate + aspirin

Drug

clopidogrel napadisilate 75mg + aspirin 100mg

clopidogrel bisulfate + aspirin

Drug

clopidogrel bisulfate 75mg + aspirin 100mg

Primary outcomes

  1. The percentage of P2Y12 receptor inhibition

    Time frame: 4 weeks

Secondary outcomes

  1. Adverse events after study medication

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • Hanmi Pharmaceutical co., ltd.

Registry information

Important dates

Study start
2010
Primary completion
2012
First posted
Apr 25, 2012
Registry last updated
Apr 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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