Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT)
Background and Purpose: We aimed to investigate the effect of Ginkgolide® treatment on neurological function in patients receiving intravenous (IV) recombinant tissue plasminogen activator (rt-PA).Methods: This cluster randomized controlled trial included acute ischemic stroke patients in 24 centers...
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Frontiers Media S.A.
2021
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oai:doaj.org-article:c9c35434375f441f98fa3223e6823cff2021-12-03T16:51:20ZGinkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT)1663-981210.3389/fphar.2021.792136https://doaj.org/article/c9c35434375f441f98fa3223e6823cff2021-12-01T00:00:00Zhttps://www.frontiersin.org/articles/10.3389/fphar.2021.792136/fullhttps://doaj.org/toc/1663-9812Background and Purpose: We aimed to investigate the effect of Ginkgolide® treatment on neurological function in patients receiving intravenous (IV) recombinant tissue plasminogen activator (rt-PA).Methods: This cluster randomized controlled trial included acute ischemic stroke patients in 24 centers randomized to intervention of intravenous Ginkgolide® or control group within the first 24 h after IV rt-PA therapy (IVT). Clinical outcome at 90 days was assessed with modified Rankin Scale (mRS) score and dichotomized into good outcome (0–2) and poor outcome (3–6). Hemorrhagic transformation represented the conversion of a bland infarction into an area of hemorrhage by computed tomography. Symptomatic intracerebral hemorrhage (sICH) was defined as cerebral hemorrhagic transformation in combination with clinical deterioration of National Institutes of Health Stroke Scale (NIHSS) score ≥4 points at 7-day or if the hemorrhage was likely to be the cause of the clinical deterioration. We performed logistic regression analysis and propensity score matching analysis to investigate the impact of Ginkgolide® treatment with IV rt-PA on good outcome, hemorrhagic transformation and sICH, respectively.Results: A total of 1113 patients were finally included and 513 (46.1%) were in the intervention group. Patients in the Ginkgolide® group were more likely to have good outcomes (78.6 vs. 66.7%, p < 0.01) and lower rate of sICH (0 vs. 2.72%, p < 0.01), compared with patients in the control group. The intra-cluster correlation coefficient (ICC) for good outcome at 90 days was 0.033. Binary logistic regression analysis revealed that treatment with Ginkgolide® was independently associated with 90-day mRS in patients with IV rt-PA therapy (OR 1.498; 95% CI 1.006–2.029, p = 0.009). After propensity score matching, conditional logistic regression showed intervention with Ginkgolide® was significantly associated with 90-day good outcome (OR 1.513; 95% CI 1.073–2.132, p = 0.018). No significant difference in hemorrhage transformation was seen between the 2 matched cohorts (OR 0.885; 95% CI 0.450–1.741, p = 0.724).Conclusion: Using Ginkgolide® within 24-hour after IV rt-PA is effective and safe and might be recommended in combination with rtPA therapy in acute ischemic stroke.Clinical Trial Registration:http://www.clinicaltrials.gov, identifier NCT03772847.Xuting ZhangWansi ZhongXiaodong MaXiaoling ZhangHongfang ChenZhimin WangMin Lou GIANT InvestigatorsYong BiXueli CaiChaochan ChengQun GuShuangxing HouHaifang HuHuadong HuangLikang LanYaxian WangDongjuan XuSui YiDechou ZhangNingyuan ZhangJianbin ZhongLianjiang ZhongFrontiers Media S.A.articleGinkgolide®strokeintravenous alteplaseprognosisimproveTherapeutics. PharmacologyRM1-950ENFrontiers in Pharmacology, Vol 12 (2021) |
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Ginkgolide® stroke intravenous alteplase prognosis improve Therapeutics. Pharmacology RM1-950 |
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Ginkgolide® stroke intravenous alteplase prognosis improve Therapeutics. Pharmacology RM1-950 Xuting Zhang Wansi Zhong Xiaodong Ma Xiaoling Zhang Hongfang Chen Zhimin Wang Min Lou GIANT Investigators Yong Bi Xueli Cai Chaochan Cheng Qun Gu Shuangxing Hou Haifang Hu Huadong Huang Likang Lan Yaxian Wang Dongjuan Xu Sui Yi Dechou Zhang Ningyuan Zhang Jianbin Zhong Lianjiang Zhong Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| description |
Background and Purpose: We aimed to investigate the effect of Ginkgolide® treatment on neurological function in patients receiving intravenous (IV) recombinant tissue plasminogen activator (rt-PA).Methods: This cluster randomized controlled trial included acute ischemic stroke patients in 24 centers randomized to intervention of intravenous Ginkgolide® or control group within the first 24 h after IV rt-PA therapy (IVT). Clinical outcome at 90 days was assessed with modified Rankin Scale (mRS) score and dichotomized into good outcome (0–2) and poor outcome (3–6). Hemorrhagic transformation represented the conversion of a bland infarction into an area of hemorrhage by computed tomography. Symptomatic intracerebral hemorrhage (sICH) was defined as cerebral hemorrhagic transformation in combination with clinical deterioration of National Institutes of Health Stroke Scale (NIHSS) score ≥4 points at 7-day or if the hemorrhage was likely to be the cause of the clinical deterioration. We performed logistic regression analysis and propensity score matching analysis to investigate the impact of Ginkgolide® treatment with IV rt-PA on good outcome, hemorrhagic transformation and sICH, respectively.Results: A total of 1113 patients were finally included and 513 (46.1%) were in the intervention group. Patients in the Ginkgolide® group were more likely to have good outcomes (78.6 vs. 66.7%, p < 0.01) and lower rate of sICH (0 vs. 2.72%, p < 0.01), compared with patients in the control group. The intra-cluster correlation coefficient (ICC) for good outcome at 90 days was 0.033. Binary logistic regression analysis revealed that treatment with Ginkgolide® was independently associated with 90-day mRS in patients with IV rt-PA therapy (OR 1.498; 95% CI 1.006–2.029, p = 0.009). After propensity score matching, conditional logistic regression showed intervention with Ginkgolide® was significantly associated with 90-day good outcome (OR 1.513; 95% CI 1.073–2.132, p = 0.018). No significant difference in hemorrhage transformation was seen between the 2 matched cohorts (OR 0.885; 95% CI 0.450–1.741, p = 0.724).Conclusion: Using Ginkgolide® within 24-hour after IV rt-PA is effective and safe and might be recommended in combination with rtPA therapy in acute ischemic stroke.Clinical Trial Registration:http://www.clinicaltrials.gov, identifier NCT03772847. |
| format |
article |
| author |
Xuting Zhang Wansi Zhong Xiaodong Ma Xiaoling Zhang Hongfang Chen Zhimin Wang Min Lou GIANT Investigators Yong Bi Xueli Cai Chaochan Cheng Qun Gu Shuangxing Hou Haifang Hu Huadong Huang Likang Lan Yaxian Wang Dongjuan Xu Sui Yi Dechou Zhang Ningyuan Zhang Jianbin Zhong Lianjiang Zhong |
| author_facet |
Xuting Zhang Wansi Zhong Xiaodong Ma Xiaoling Zhang Hongfang Chen Zhimin Wang Min Lou GIANT Investigators Yong Bi Xueli Cai Chaochan Cheng Qun Gu Shuangxing Hou Haifang Hu Huadong Huang Likang Lan Yaxian Wang Dongjuan Xu Sui Yi Dechou Zhang Ningyuan Zhang Jianbin Zhong Lianjiang Zhong |
| author_sort |
Xuting Zhang |
| title |
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| title_short |
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| title_full |
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| title_fullStr |
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| title_full_unstemmed |
Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Improving Neurological Function: A Multicenter, Cluster-Randomized Trial (GIANT) |
| title_sort |
ginkgolide with intravenous alteplase thrombolysis in acute ischemic stroke improving neurological function: a multicenter, cluster-randomized trial (giant) |
| publisher |
Frontiers Media S.A. |
| publishDate |
2021 |
| url |
https://doaj.org/article/c9c35434375f441f98fa3223e6823cff |
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