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

Joon Tae Kim, Jihoon Kang, Beom Joon Kim, Jun Yup Kim, Moon Ku Han, Ki Hyun Cho, Man Seok Park, Kang Ho Choi, Jong Moo Park, Kyusik Kang, Yong Soo Kim, Soo Joo Lee, Jae Guk Kim, Jae Kwan Cha, Dae Hyun Kim, Tai Hwan Park, Sang Soon Park, Jin Kyo Choi, Kyungbok Lee, Kwang Yeol ParkHae Bong Jeong, Jun Lee, Doo Hyuk Kwon, Yong Jin Cho, Keun Sik Hong, Hong Kyun Park, Byung Chul Lee, Kyung Ho Yu, Mi Sun Oh, Minwoo Lee, Dong Eog Kim, Dong Seok Gwak, Jay Chol Choi, Joong Goo Kim, Chul Hoo Kang, Jee Hyun Kwon, Wook Joo Kim, Dong Ick Shin, Kyu Sun Yum, Sung Il Sohn, Jeong Ho Hong, Hyungjong Park, Chulho Kim, Sang Hwa Lee, Juneyoung Lee, Philip B. Gorelick, Bo Norrving, Hee Joon Bae

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
Pages (from-to)1015-1020
Number of pages6
JournalInternational Journal of Stroke
Volume18
Issue number8
DOIs
StatePublished - Oct 2023

Keywords

  • Dual antiplatelet therapy
  • ischemic stroke
  • large artery atherosclerosis
  • treatment duration

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