Rationale and design of the efficacy and safety of combination of cilostazol and gingko biloba extract EGb 761 in patients with acute non-cardioembolic ischemic stroke (RENEW): A pilot and feasibility randomized controlled trial.

Autor: Ha SH; Department of Neurology, Gil Medical Center, Gachon University, Incheon, South Korea., Lee YB; Department of Neurology, Gil Medical Center, Gachon University, Incheon, South Korea., Kang HG; Department of Neurology, Jeonbuk University College of Medicine, Jeonju, South Korea., Choi KH; Department of Neurology, Chonnam University College of Medicine, Gwang-ju, South Korea., Kim BJ; Department of Neurology, Seoul National University Bundang Hospital, Seoul National University College of Medicine, Seoul, South Korea., Woo HG; Department of Neurology, Kyung Hee Medical Center, Kyung Hee University College of Medicine, Seoul, South Korea., Kwon HS; Department of Neurology, Hanyang University Guri Hospital, Hanyang University College of Medicine, Guri, Republic of Korea., Song TJ; Department of Neurology, Seoul Hospital, College of Medicine, Ewha Womans University, Seoul, South Korea. Electronic address: knstar@ewha.ac.kr., Kim BJ; Department of Neurology, Asan Medical Center, University of Ulsan, Seoul, South Korea. Electronic address: medicj80@hanmail.net.
Jazyk: angličtina
Zdroj: Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association [J Stroke Cerebrovasc Dis] 2024 Nov 10; Vol. 34 (1), pp. 108105. Date of Electronic Publication: 2024 Nov 10.
DOI: 10.1016/j.jstrokecerebrovasdis.2024.108105
Abstrakt: Background: Dual antiplatelet therapy with aspirin and clopidogrel is the standard treatment for acute ischemic stroke (AIS). Cilostazol has emerged as a safe alternative with pleiotropic effects that prevent stroke without increasing the risk of bleeding and has been shown to reduce neurological deterioration (ND) in the acute phase. Ginkgo biloba extract (EGb 761) has also been reported to improve neurological impairment following AIS. This trial aimed to evaluate the efficacy and safety of the combination of cilostazol and EGb 761 in reducing early stroke recurrence and ND in patients with non-cardioembolic AIS.
Methods: The RENEW trial is a prospective, randomized, active-controlled, double-blind, parallel, multicenter phase IV study. Five hundred patients with non-cardioembolic AIS presenting within 72 h of symptom onset will be randomized to receive either aspirin 100 mg and cilostazol 200 mg plus EGb 761 160 mg daily or aspirin 100 mg and clopidogrel 75 mg daily for 90 days. The primary outcomes included the combined ND rate during hospitalization and stroke recurrence within 90 days. Secondary outcomes included the rates of ND, recurrent AIS, hemorrhagic stroke, hemorrhagic transformation, functional outcomes (modified Rankin Scale 0-2), bleeding events, and changes in the dizziness handicap inventory scores.
Discussion: The RENEW trial is expected to provide evidence for the safety and efficacy of combining aspirin, cilostazol, and EGb 761 as an alternative to standard therapy for the acute management of non-cardioembolic AIS.
Trial Registration: This trial was registered at ClinicalTrials.gov (NCT05445895).
Competing Interests: Declaration of competing interest None.
(Copyright © 2024. Published by Elsevier Inc.)
Databáze: MEDLINE
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