NCT02609698

ISAR-DAPT (A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial)

A Comparative Evaluation of Efficacy and Safety in the 3-Months DAPT Group vs. the 6-Months DAPT Group of Patients Treated With the Coroflex ISAR Stent; A Prospective, Multicenter, Randomized, Open-Label Clinical Trial

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 906 (estimated)
• Sponsor: Ajou University School of Medicine · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

This clinical trial studies patients treated with the Coroflex ISAR Stent for coronary artery disease in order for the objective of verifying the non-inferiority of results that among patients who were administered DAPT for 3 months compared to patients who were administered DAPT for 6 months, in terms of the efficacy and safety of DAPT.

Conditions

• Stable Angina, Unstable Angina, Silent Coronary Ischemia, Coronary Artery Disease

Interventions

Type	Name	Description
DEVICE	Coroflex ISAR	This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
DRUG	3 months DAPT
DRUG	6 months DAPT

Timeline

• Start date: 2015-08-01
• Primary completion: 2018-12-01
• Completion: 2019-06-01
• First posted: 2015-11-20
• Last updated: 2015-11-20

Locations

1 site across 1 country: South Korea