Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial (GIANT)
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|ClinicalTrials.gov Identifier: NCT03772847|
Recruitment Status : Recruiting
First Posted : December 11, 2018
Last Update Posted : March 20, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Intravenous Alteplase Thrombolysis Neurological Improving||Drug: ginkgolide||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1120 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial|
|Actual Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||May 1, 2020|
Experimental: ginkgolide group
ginkgolide plus alteplase
ginkgolide plus alteplase
No Intervention: control
- proportion of patients with a 90-day modified Rankin Scale (mRS) score below 2 [ Time Frame: 90 days ]mRS 0-6, higher indicate worse outcome
- National Institute of Health Stroke Scale(NIHSS) scores between the two groups at baseline, 24 hours, 7 days, and 14 days [ Time Frame: 14 days ]NIHSS 0-42, and higher indicate worse outcome
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772847
|Contact: Min Lou, PhD||+86 0571 email@example.com|
|Hangzhou, Zhejiang, China, 310000|
|Contact: Zexin Chen 13757118366 HREC2013@126.com|
|Study Chair:||Ze Xin Chen||2nd affiliated hospital of Zhejiang University，School of Medicine|