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Effect of Ginkgolide in Ischemic Stroke patients with large Artery Atherosclerosis: Results from a randomized trial.

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机构： [1]Department of Neurology, Huashan Hospital affiliated to Fudan University, Shanghai, China. [2]Department of Neurology, The Fourth Hospital affiliated to Harbin Medical University, Harbin, China. [3]Department of Neurology, Hejian People's Hospital, Hejian, China. [4]Department of Neurology, Dandong People's Hospital, Dandong, China. [5]Department of Neurology, Central Hospital affiliated to Shenyang Medical College, Shenyang, China. [6]Department of Neurology, Nanshi Hospital affiliated to Henan University, Henan, China. [7]Department of Neurology, Pudong New Area People's Hospital, Shanghai, China. [8]Department of Neurology, Dandong First Hospital, Dandong, China. [9]Department of Neurology, Pingdingshan Municipal Second People's Hospital, Pingdingshan, China. [10]Department of Neurology, Handan Central Hospital, Hebei, China. [11]Department of Neurology, Guizhou Medical University affiliating Hospital, China. [12]Department of Neurology, The First People's Hospital, Ruzhou, China. [13]Department of Neurology, Zhecheng People's Hospital, Zhecheng, China. [14]Department of Neurology, Transportation Center Hospital, Yunnan, China. [15]Department of Neurology, Jiangsu University affiliating Hospital, Jiangsu, China.

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Dual antiplatelet therapy is considered beneficial in acute ischemic stroke (AIS) patients with intracranial artery stenosis (ICAS), with more bleeding events. Ginkgolide is shown to reduce platelet activation after infarction, which might be of benefit in AIS. We aimed to explore the effect of Ginkgolide in AIS patients with ICAS.This was a randomized, double-blinded, placebo-controlled trial conducted at 61 centers in China. Within 72 h after onset, consecutive patients diagnosed as AIS with ICAS were randomized to either Ginkgolide or placebo treatment. The primary outcome was the composite of mortality and recurrent stroke (ischemic or hemorrhagic) during first 4 weeks in an intention-to-treat analysis. Secondary functional outcome was assessed by modified Rankin Scale and improvement of stroke severity was assessed by National Institution of Health Stroke Scale at day 28. Safety outcome was measured by the rate of severe adverse event (SAE).There were 936 patients randomized to either Ginkgolide or placebo treatment. Their average age was 64.2 ± 10.4 years old and 36.0% of the patients were female. The composite index event occurred in six patients in placebo group, and none occurred in Ginkgolide group (risk ratio 1.01; 95% CI 1.00-1.02). There were more patients who achieved favorable outcome in Ginkgolide group, compared with that of the placebo group (OR 2.16, 95%CI 1.37-3.41). SAE occurred in five (1.1%) patients in the Ginkgolide group and three (0.6%) in the placebo group (OR0.60, 95CI% 0.14-2.53). Intracranial hemorrhage occurred in 1/473 (0.2%) in the placebo group.Ginkgolide, working as PAF antagonist, may reduce recurrent stroke in AIS with ICAS patients within 72 hours after onset. It might be an optional treatment in moderate-to-severe AIS patients with ICAS. (http://www.chictr.org.cn Number as ChiCTR-IPR-17012310).© 2021 The Authors. CNS Neuroscience & Therapeutics published by John Wiley & Sons Ltd.

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出版当年[2021]版：

大类 | 2 区医学

小类 | 2 区神经科学 2 区药学

最新[2023]版：

大类 | 1 区医学

小类 | 2 区神经科学 2 区药学

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第一作者机构： [1]Department of Neurology, Huashan Hospital affiliated to Fudan University, Shanghai, China.

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通讯机构： [1]Department of Neurology, Huashan Hospital affiliated to Fudan University, Shanghai, China. [*1]No.12 Urimuqi Middle Road, Jin An District, Shanghai, 200040, China

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