Intravenous Alteplase Thrombolysis

Neurological Improving

ginkgolide

Min Lou

Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial

NIHSS 0-42, and higher indicate worse outcome

Second Affiliated Hospital, School of Medicine, Zhejiang University

Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours;combined with Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.

Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.

Ischemic Stroke

The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours.

Ginkgo Diterpene Lactone Meglumine Injection

Acetylsalicylic acid

Ginkgo Diterpene Lactone Meglumine Injection on Platelet Reactivity in Acute Ischemic Stroke

A Randomized, Active-Controlled，Blinded-Endpoint and Parallel Group Pilot Trial Comparing the Antiplatelet Effects of Ginkgo Diterpene Lactone Meglumine Injection Plus Aspirin Versus Aspirin Alone in Patients With Acute Ischemic Stroke

Residual Platelet Reactivity defined as the value of Aspirin Reaction Unit (ARU) measured by VerifyNow® assay on day 14.

Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid.

Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.

Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of PAF(Platelet activating factor).

Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®) using the inducer of collegen.

Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®) using the inducer of adrenaline.

Residual platelet reactivity defined as the value of Maximum Amplitude- acetylsalicylic acid (MA-AA) measured by Thrombelastography Platelet Mapping Assay (TEG) using the inducer of acetylsalicylic acid.

Residual platelet reactivity defined as the value of Maximum Amplitude- adenosine diphosphate (MA-AA) measured by Thrombelastography Platelet Mapping Assay (TEG) using the inducer of adenosine diphosphate

Residual platelet reactivity defined as the value of Aspirin reaction unit (ARU) measured by VerifyNow® assay at 24 hours.

High on-treatment platelet reactivity defined as Aspirin reactivity unit (ARU)> 555 measured by VerifyNow® assay.

Residual platelet reactivity detected by AspirinWorks.

Changes in NIHSS and mRS at 14 days and 90 days.

Modified Rankin Scale score changes (continuous) and dichotomized at percentage with score 0-2 vs. 3-6

All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature. When there was disagreement, a third senior neurologist was consulted to reach a consensus decision.

The PLATO(Platelet Inhibition and Patient Outcomes) definition of fatal/life-threatening of major bleed is any one of the following: Fatal, Intracranial, Intrapericardial bleed with cardiac tamponade, Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery, Clinically overt or apparent bleeding associated with a decrease in hemoglobin(Hb) of more than50 g/L, Transfusion of 4 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding. The PLATO definition of other of major bleed is any one of the following:Significantly disabling (eg. intraocular with permanent vision loss), Clinically overt or apparent bleeding associated with a decrease in Hb of 30 g/L to 50 g/L, Transfusion of 2-3 units (whole blood or PRBCs) for bleeding.

Intracranial hemorrhagic events is assessed by brain computed tomography (CT) or gradient recalled echo (GRE) T2 star weighted MRI.

All deaths reported post-randomization will be recorded and adjudicated. Deaths will be subclassified by the adjudication committee as cardiovascular or non-cardiovascular.

RenJi Hospital

Jiangsu Kanion Pharmaceutical Co., Ltd

ginkgo diterpene lactone meglumine injection

Ginkgo diterpene lactone meglumine injection simulation

5 ml,oral,5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.

Ginkgo diterpene lactone meglumine injection

Tiantan Hospital

A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.

yongjun wang

professor

Ministry of Science and Technology of the People´s Republic of China

Beijing Bionovo Medicine Development Co., Ltd.

Intravenous drip slowly. A 1 (25 mg), will be taken slowly into the 0.9% sodium chloride injection diluted in 250 ml before use, then slow intravenous drip, once a day. The dripping speed must be strictly controlled. For the first time when using Ginkgolides Meglumine Injection, dripping speed should be controlled for 10 ~ 15 drops per minute. After 30 minutes treatment without discomfort, dripping speed can be appropriately increased, but no more than 30 drops per minute.

Ginkgolides Meglumine Injection

The first affiliated hospital with Nanjing Medical University

Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

Blood will be drawn from adult subjects pre-drug application and at 30min, 60min, 90min, 150min, 197min, 205min, 215min, 240min (4h), 300min(5h), 360min (6h), 480min (8h）， 720min (12h)，1440min(24h)，2160min(36h)， 2880min (48h)， 4320min (72h). Urine will be drawn from adult subjects pre-drug application and at 0-4, 4-6, 6-12, 12-24, 24-48, 48-72.

Biological sample including blood, urine, faeces for PK will be collected at the same time point.

Adverse event reports will be assessed at 0, 4 days. Vital sign measurements will be assessed at pre-drug application and 30min, 60mi, 120min, 197min, 4h, 12h, 24h, 48h, 72h after application. Electrocardiogram will be assessed at 0, 4 days. Electrocardiogram monitoring will be assessed during medication period. Clinical laboratory tests will be assessed at 0, 4 days.

Intravenous drip slowly. A 1 (25 mg), will be taken slowly into the 0.9% sodium chloride injection diluted in 250 ml before use, then slow intravenous drip, once a day. The dripping speed must be strictly controlled. For the first time when using, dripping speed should be controlled for 10 ~ 15 drops per minute. After 30 minutes treatment without discomfort, dripping speed can be appropriately increased, but no more than 30 drops per minute.

25mg, intravenous drip, once a day. Number of Cycles: 14 days.

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A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.

A Multicenter Safety Clinical Trial of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke With Syndrome of Intermingled Phlegm and Blood Stasis.

lactone/stroke

Ginkgolide With Intravenous Alteplase Thrombolysis in Acute Ischemic Stroke Neurological Improving Trial

Ginkgo Diterpene Lactone Meglumine Injection on Platelet Reactivity in Acute Ischemic Stroke

A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.

Preliminary Study of Pharmacokinetics of Ginkgolides Meglumine Injection.

A Safety Study of Ginkgolides Meglumine Injection in the Treatment of Ischemic Stroke.

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