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