Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial : Rationale and design
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:18 |
|---|---|
| Enthalten in: |
International journal of stroke : official journal of the International Stroke Society - 18(2023), 8 vom: 03. Okt., Seite 1015-1020 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Kim, Joon-Tae [VerfasserIn] |
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| Links: |
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| Anmerkungen: |
Date Completed 20.09.2023 Date Revised 20.09.2023 published: Print-Electronic CRiS: KCT0004407 Citation Status MEDLINE |
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| doi: |
10.1177/17474930231168742 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
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| 100 | 1 | |a Kim, Joon-Tae |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Dual antiplatelet Use for extended period taRgeted to AcuTe ischemic stroke with presumed atherosclerotic OrigiN (DURATION) trial |b Rationale and design |
| 264 | 1 | |c 2023 | |
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| 500 | |a Date Completed 20.09.2023 | ||
| 500 | |a Date Revised 20.09.2023 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a CRiS: KCT0004407 | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a RATIONALE: The optimal duration of dual antiplatelet therapy (DAPT) with clopidogrel-aspirin for the large artery atherosclerotic (LAA) stroke subtype has been debated | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a DISCUSSION: This study will help stroke physicians determine the appropriate duration of dual therapy with clopidogrel-aspirin for patients with the LAA stroke subtype | ||
| 520 | |a TRIAL REGISTRATION: URL: https://cris.nih.go.kr/cris. CRIS Registration Number: KCT0004407 | ||
| 650 | 4 | |a Randomized Controlled Trial | |
| 650 | 4 | |a Multicenter Study | |
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a Dual antiplatelet therapy | |
| 650 | 4 | |a ischemic stroke | |
| 650 | 4 | |a large artery atherosclerosis | |
| 650 | 4 | |a treatment duration | |
| 650 | 7 | |a Platelet Aggregation Inhibitors |2 NLM | |
| 650 | 7 | |a Clopidogrel |2 NLM | |
| 650 | 7 | |a A74586SNO7 |2 NLM | |
| 650 | 7 | |a Aspirin |2 NLM | |
| 650 | 7 | |a R16CO5Y76E |2 NLM | |
| 700 | 1 | |a Kang, Jihoon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Beom Joon |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jun Yup |e verfasserin |4 aut | |
| 700 | 1 | |a Han, Moon-Ku |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Ki-Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Man-Seok |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Kang-Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Jong-Moo |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Kyusik |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Yong Soo |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Soo Joo |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Jae Guk |e verfasserin |4 aut | |
| 700 | 1 | |a Cha, Jae-Kwan |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Dae-Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Tai Hwan |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Sang-Soon |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Jin Kyo |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Kyungbok |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Kwang-Yeol |e verfasserin |4 aut | |
| 700 | 1 | |a Jeong, Hae-Bong |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Jun |e verfasserin |4 aut | |
| 700 | 1 | |a Kwon, Doo Hyuk |e verfasserin |4 aut | |
| 700 | 1 | |a Cho, Yong-Jin |e verfasserin |4 aut | |
| 700 | 1 | |a Hong, Keun-Sik |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Hong-Kyun |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Byung-Chul |e verfasserin |4 aut | |
| 700 | 1 | |a Yu, Kyung-Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Oh, Mi Sun |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Minwoo |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Dong-Eog |e verfasserin |4 aut | |
| 700 | 1 | |a Gwak, Dong-Seok |e verfasserin |4 aut | |
| 700 | 1 | |a Choi, Jay Chol |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Joong-Goo |e verfasserin |4 aut | |
| 700 | 1 | |a Kang, Chul-Hoo |e verfasserin |4 aut | |
| 700 | 1 | |a Kwon, Jee-Hyun |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Wook-Joo |e verfasserin |4 aut | |
| 700 | 1 | |a Shin, Dong-Ick |e verfasserin |4 aut | |
| 700 | 1 | |a Yum, Kyu Sun |e verfasserin |4 aut | |
| 700 | 1 | |a Sohn, Sung Il |e verfasserin |4 aut | |
| 700 | 1 | |a Hong, Jeong-Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Park, Hyungjong |e verfasserin |4 aut | |
| 700 | 1 | |a Kim, Chulho |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Sang-Hwa |e verfasserin |4 aut | |
| 700 | 1 | |a Lee, Juneyoung |e verfasserin |4 aut | |
| 700 | 1 | |a Gorelick, Philip B |e verfasserin |4 aut | |
| 700 | 1 | |a Norrving, Bo |e verfasserin |4 aut | |
| 700 | 1 | |a Bae, Hee-Joon |e verfasserin |4 aut | |
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