A Phase 4 interventional study of ginkgolide in Intravenous Alteplase Thrombolysis and Neurological Improving, sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-06.
Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Phase 4, Interventional, and Treatment
Previous clinical studies have confirmed that revascularization or recanalization rate after intravenous thrombolysis is closely related to the formation of thrombus, which also results in poor neurological function after thrombolysis. Platelet activating factor (PAF) strong platelet aggregation may be involved in thrombosis. Formation process. The main components of Ginkgolide injection (Ginkgo) are ginkgolide, ginkgolides A, ginkgolides B and ginkgolides C. Ginkgo biloba lactone can antagonize PAF and has strong anti-platelet aggregation. . Therefore, it can be speculated that ginkgolides injection combined with alteplase intravenous thrombolysis may improve the recanalization rate after thrombolysis and reduce the reocclusion rate.
In addition, clinical studies have also found that ginkgolide injection has a good auxiliary effect on hypertensive intracerebral hemorrhage, which can regulate inflammatory factors such as IL-6, TNF-α and high-sensitivity C-reactive protein (CRP) in patients. Recovery of neurological function in patients. It is well known that TNF-α, IL-β, IL-1, IL-6, IFN-γ, etc. are all inflammatory factors associated with reperfusion injury. Therefore, we speculate that ginkgolides injection may also regulate inflammatory factors associated with reperfusion injury, such as IL-6, TNF-α, thereby reducing reperfusion injury, thereby improving patient prognosis.
The aim of this study was to determine the clinical efficacy of ginkgolides injection combined with alteplase in the treatment of acute ischemic stroke, and to improve the prognosis of patients with thrombolysis.
Second Affiliated Hospital, Zhejiang University, School of Medicine is the lead sponsor of 97 studies on the registry; 65 are open to participants now.
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Exclusion Criteria:
ginkgolide plus alteplase
Drug: ginkgolide
alteplase
ginkgolide plus alteplase
proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2
mRS 0-6, higher indicate worse outcome
Time frame: 90 days
National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days
NIHSS 0-42, and higher indicate worse outcome
Time frame: 14 days
recurrence rate of cerebrovascular disease in 1-month and 3-month follow-up
Time frame: 3 months
incidence of compound events (include cerebrovascular events,myocardial infarction, angina pectoris, and systemic embolism）
Time frame: 1 year
Ran from Jul 2018 to primary completion in May 2020, 21 months.
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This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, Zhejiang University, School of Medicine