NCT01830491

Comparison of Effect & Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients

Comparison of Antiplatelet Effect and Safety of Clopidogrel Napadisilate With Clopidogrel Bisulfate in Coronary Artery Disease Patients: Multi-center, Randomized, Double-blind, Phase IV Clinical Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 162 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to demonstrate that the combination therapy of aspirin and clopidogrel napadisilate is not inferior to that of aspirin and clopidogrel bisulfate with respect to its effectiveness in inhibiting platelet aggregation, if it is given for four weeks to Coronary Artery Disease (CAD) patients who had been treated with a drug-eluting stent before \> 12 months and had remained in a stable condition with a single antiplatelet agent, aspirin.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	Clopidogrel
DRUG	aspirin 100mg

Timeline

• Start date: 2009-03-01
• Primary completion: 2009-08-01
• Completion: 2009-12-01
• First posted: 2013-04-12
• Last updated: 2016-10-12