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ORIGINAL RESEARCH article

Front. Pharmacol.
Sec. Neuropharmacology
Volume 15 - 2024 | doi: 10.3389/fphar.2024.1452174

Efficacy and Safety of Ginkgolide with Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke with Large Vessel Occlusion: A subgroup analysis of GIANT

Provisionally accepted
Zheyu Zhang Zheyu Zhang 1Wansi Zhong Wansi Zhong 1Xuting Zhang Xuting Zhang 1Xiaodong Ma Xiaodong Ma 2Xudong Lu Xudong Lu 3Meixia Zhang Meixia Zhang 4Anyang Tao Anyang Tao 5Bing Zhang Bing Zhang 6Min Lou Min Lou 1*
  • 1 Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China
  • 2 Haiyan People's Hospital, Zhejiang, China
  • 3 Second Hospital of Jiaxing City, Jiaxing, Zhejiang Province, China
  • 4 Jinhua Central Hospital, Jinhua, Zhejiang Province, China
  • 5 Taizhou First People's Hospital, Taizhou, China
  • 6 Huzhou Central Hospital, Huzhou, China

The final, formatted version of the article will be published soon.

    Aim: To explore the effectiveness and safety of Ginkgolide ® in acute ischemic stroke (AIS) patients with large vessel occlusion (LVO) and moderate-to-severe stroke receiving intravenous alteplase thrombolysis (IVT).Improving Neurological Function (GIANT) was an open label, prospective, multicenter cluster-randomized clinical trial and included AIS patients in 24 centers randomized to intervention of intravenous Ginkgolide ® or control group within the first 24 h after IVT. LVO was defined as any occlusion of internal carotid artery, M1 or M2 of middle cerebral artery, A1 or A2 of anterior cerebral artery, P1 of posterior cerebral artery, V4 of vertebral artery or basilar artery.Stroke severity was assessed with National Institutes of Health Stroke Scale (minor ≤5; moderate-to-severe >5). Primary outcome was a good outcome, defined as a modified Rankin Scale (mRS) of, 0-2 at 90 days. Secondary outcomes were early neurological improvement (ENI) defined as ≥18% increase of National Institutes of Health Stroke Scale (NIHSS) score at 7 days compared to baseline and distribution of mRS at 3 month.Results: A total of 1,113 patients were included, with 268/913 (29.4%) presenting LVO and 508 (45.6%) presenting moderate-to-severe stroke. In patients with LVO, Ginkgolide ® usage was independently associated with ENI (P = 0.001), but not with good outcome (P = 0.154). In moderate-to-severe subgroup, Ginkgolide ® was independently associated with both good outcome (P = 0.009) and ENI (P = 0.028). Ginkgolide ® did not increase the risk of hemorrhagic transformation (all P > 0.05).Using Ginkgolide ® within 24-hour after intravenous rt-PA is effective and safe in LVO and moderate-to-severe stroke patients.

    Keywords: Ginkgolide, Acute ischemic stroke, Intravenous alteplase, Minor stroke, Large vessel occlusion

    Received: 20 Jun 2024; Accepted: 12 Aug 2024.

    Copyright: © 2024 Zhang, Zhong, Zhang, Ma, Lu, Zhang, Tao, Zhang and Lou. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Min Lou, Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.