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Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial: Rationale and design

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Author(s)
Joon-Tae KimJihoon KangBeom Joon KimJun Yup KimMoon-Ku HanKi-Hyun ChoMan-Seok ParkKang-Ho ChoiJong-Moo ParkKyusik KangYong Soo KimSoo Joo LeeJae Guk KimJae-Kwan ChaDae-Hyun KimTai Hwan ParkSang-Soon ParkJin Kyo ChoiKyungbok LeeKwang-Yeol ParkHae-Bong JeongJun LeeDoo Hyuk KwonYong-Jin ChoKeun-Sik HongHong-Kyun ParkByung-Chul LeeKyung-Ho YuMi Sun OhMinwoo LeeDong-Eog KimDong-Seok GwakJay Chol ChoiJoong-Goo KimChul-Hoo KangJee-Hyun KwonWook-Joo KimDong-Ick ShinKyu Sun YumSung Il SohnJeong-Ho HongHyungjong ParkChulho KimSang-Hwa LeeJuneyoung LeePhilip B GorelickBo NorrvingHee-Joon Bae
Keimyung Author(s)
Sohn, Sung IlPark, Hyung JongHong, Jeong Ho
Department
Dept. of Neurology (신경과학)
Journal Title
Int J Stroke
Issued Date
2023
Volume
18
Issue
8
Keyword
Dual antiplatelet therapyischemic strokelarge artery atherosclerosistreatment duration
Abstract
Rationale:
The optimal duration of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin for the large artery atherosclerotic (LAA) stroke subtype has been debated.

Aims:
To determine whether the 1-year risk of recurrent vascular events could be reduced by a longer duration of DAPT in patients with the LAA stroke subtype.

Methods and study design:
A total of 4806 participants will be recruited to detect a statistically significant relative risk reduction of 22% with 80% power and a two-sided alpha error of 0.05, including a 10% loss to follow-up. This is a registry-based, multicenter, prospective, randomized, open-label, blinded end point study designed to evaluate the efficacy and safety of a 12-month duration of DAPT compared with a 3-month duration of DAPT in the LAA stroke subtype. Patients will be randomized (1:1) to either DAPT for 12 months or DAPT for 3 months, followed by monotherapy (either aspirin or clopidogrel) for the remaining 9 months.

Study outcomes:
The primary efficacy outcome of the study is a composite of stroke (ischemic or hemorrhagic), myocardial infarction, and all-cause mortality for 1 year after the index stroke. The secondary efficacy outcomes are (1) stroke, (2) ischemic stroke or transient ischemic attack, (3) hemorrhagic stroke, and (4) all-cause mortality. The primary safety outcome is major bleeding.

Discussion:
This study will help stroke physicians determine the appropriate duration of dual therapy with clopidogrel-aspirin for patients with the LAA stroke subtype.

Trial registration:
URL: https://cris.nih.go.kr/cris. CRIS Registration Number: KCT0004407.
Keimyung Author(s)(Kor)
손성일
박형종
홍정호
Publisher
School of Medicine (의과대학)
Type
Article
ISSN
1747-4949
Source
https://journals.sagepub.com/doi/10.1177/17474930231168742
DOI
10.1177/17474930231168742
URI
https://kumel.medlib.dsmc.or.kr/handle/2015.oak/45115
Appears in Collections:
1. School of Medicine (의과대학) > Dept. of Neurology (신경과학)
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