Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial: Rationale and design
- Authors
- Kim, Joon-Tae; Kang, Jihoon; Kim, Beom Joon; Kim, Jun Yup; Han, Moon-Ku; Cho, Ki-Hyun; Park, Man-Seok; Choi, Kang-Ho; Park, Jong-Moo; Kang, Kyusik; Kim, Yong Soo; Lee, Soo Joo; Kim, Jae Guk; Cha, Jae-Kwan; Kim, Dae-Hyun; Park, Tai Hwan; Park, Sang-Soon; Choi, Jin Kyo; Lee, Kyungbok; Park, Kwang-Yeol; Jeong, Hae-Bong; Lee, Jun; Kwon, Doo Hyuk; Cho, Yong-Jin; Hong, Keun-Sik; Park, Hong-Kyun; Lee, Byung-Chul; Yu, Kyung-Ho; Oh, Mi Sun; Lee, Minwoo; Kim, Dong-Eog; Gwak, Dong-Seok; Choi, Jay Chol; Kim, Joong-Goo; Kang, Chul-Hoo; Kwon, Jee-Hyun; Kim, Wook-Joo; Shin, Dong-Ick; Yum, Kyu Sun; Sohn, Sung Il; Hong, Jeong-Ho; Park, Hyungjong; Kim, Chulho; Lee, Sang-Hwa; Lee, Juneyoung; Gorelick, Philip B.; Norrving, Bo; Bae, Hee-Joon
- Issue Date
- Apr-2023
- Publisher
- Blackwell
- Keywords
- Dual antiplatelet therapy; ischemic stroke; large artery atherosclerosis; treatment duration
- Citation
- International Journal of Stroke, v.18, no.8, pp 1015 - 1020
- Pages
- 6
- Indexed
- SCIE
SCOPUS
- Journal Title
- International Journal of Stroke
- Volume
- 18
- Number
- 8
- Start Page
- 1015
- End Page
- 1020
- URI
- https://scholarworks.korea.ac.kr/kumedicine/handle/2021.sw.kumedicine/63144
- DOI
- 10.1177/17474930231168742
- ISSN
- 1747-4930
1747-4949
- 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
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- Appears in
Collections - 1. Basic Science > Department of Biostatistics > 1. Journal Articles
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