Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial : Rationale and design
(2023) In International Journal of Stroke 18(8). p.1015-1020- 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... (More)
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.
(Less)
- author
- organization
- publishing date
- 2023
- type
- Contribution to journal
- publication status
- published
- subject
- keywords
- Dual antiplatelet therapy, ischemic stroke, large artery atherosclerosis, treatment duration
- in
- International Journal of Stroke
- volume
- 18
- issue
- 8
- pages
- 1015 - 1020
- publisher
- Wiley-Blackwell
- external identifiers
-
- pmid:36974902
- scopus:85153707928
- ISSN
- 1747-4930
- DOI
- 10.1177/17474930231168742
- language
- English
- LU publication?
- yes
- id
- 1bb31c16-60bd-4567-9d54-23f1b4db4c2c
- date added to LUP
- 2023-07-14 12:38:16
- date last changed
- 2024-04-19 23:30:59
@article{1bb31c16-60bd-4567-9d54-23f1b4db4c2c,
abstract = {{<p>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.</p>}},
author = {{Kim, Joon Tae and Kang, Jihoon and Kim, Beom Joon and Kim, Jun Yup and Han, Moon Ku and Cho, Ki Hyun and Park, Man Seok and Choi, Kang Ho and Park, Jong Moo and Kang, Kyusik and Kim, Yong Soo and Lee, Soo Joo and Kim, Jae Guk and Cha, Jae Kwan and Kim, Dae Hyun and Park, Tai Hwan and Park, Sang Soon and Choi, Jin Kyo and Lee, Kyungbok and Park, Kwang Yeol and Jeong, Hae Bong and Lee, Jun and Kwon, Doo Hyuk and Cho, Yong Jin and Hong, Keun Sik and Park, Hong Kyun and Lee, Byung Chul and Yu, Kyung Ho and Oh, Mi Sun and Lee, Minwoo and Kim, Dong Eog and Gwak, Dong Seok and Choi, Jay Chol and Kim, Joong Goo and Kang, Chul Hoo and Kwon, Jee Hyun and Kim, Wook Joo and Shin, Dong Ick and Yum, Kyu Sun and Sohn, Sung Il and Hong, Jeong Ho and Park, Hyungjong and Kim, Chulho and Lee, Sang Hwa and Lee, Juneyoung and Gorelick, Philip B. and Norrving, Bo and Bae, Hee Joon}},
issn = {{1747-4930}},
keywords = {{Dual antiplatelet therapy; ischemic stroke; large artery atherosclerosis; treatment duration}},
language = {{eng}},
number = {{8}},
pages = {{1015--1020}},
publisher = {{Wiley-Blackwell}},
series = {{International Journal of Stroke}},
title = {{Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial : Rationale and design}},
url = {{http://dx.doi.org/10.1177/17474930231168742}},
doi = {{10.1177/17474930231168742}},
volume = {{18}},
year = {{2023}},
}