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- Title
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
- 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
- Subjects
ISCHEMIC stroke; TRANSIENT ischemic attack; HEMORRHAGIC stroke; STROKE; PLATELET aggregation inhibitors
- Publication
International Journal of Stroke, 2023, Vol 18, Issue 8, p1015
- ISSN
1747-4930
- Publication type
Article
- DOI
10.1177/17474930231168742