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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)

NCT02609698 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 906

Last updated 2015-11-20

No results posted yet for this study

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

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

Sponsors & Collaborators

  • B. Braun Korea Co., Ltd.

    collaborator INDUSTRY

  • Ajou University School of Medicine

    lead OTHER

Principal Investigators

  • Myeong-Ho Yoon, Ph.D, MD · Cardiovascular Center, Ajou University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-31
Primary Completion
2018-12-31
Completion
2019-06-30

Countries

  • South Korea

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02609698 on ClinicalTrials.gov