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)

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.

Timeline

Start

2015-08

Primary completion

2018-12

Completion

2019-06

Outcome

Missed primary endpoint

paper occurred in 9 (3.7%) patients in the 3-month DAPT group and in 7 (2.9%) patients in the 6-month DAPT group (hazard ratio 1.31; P=.60). PMID 35863061 ↗

Publications

• Jin U, Seo KW, Yang HM, Lim HS, Choi BJ, Choi SY, Shin JH, Tahk SJ, Yoo SY, Rha SW, Chung WY, Kim CH, Won KB, Pyun WB, Jang JS, Lee SY, Hong YJ, Kim MH, Hong SJ, Choi YS, Kim HY, Choi RK, Kang WC, Cho EJ, Yoon MH. Efficacy and Safety of 3 Versus 6 Months of Dual-Antiplatelet Therapy in Patients Implanted With a Coroflex ISAR Stents: A Prospective, Multicenter, Randomized Clinical Trial. J Invasive Cardiol. 2022 Sep;34(9):E653-E659. doi: 10.25270/jic/21.00330. Epub 2022 Jul 22.

Drugs

Indications