Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke

Study Overview
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Brief Summary
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This study evaluates the addition of Ginkgo Diterpene Lactone Meglumine Injection to aspirin in the treatment of acute ischemic stroke.Half of patient will receive Ginkgo Diterpene Lactone Meglumine Injection(25mg once/day D1-D14) and aspirin(100mg once/day D1-D14) in combination, while the other half will receive aspirin(100mg once/day D1-D14).

Detailed Description
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This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5<NIHSS < 24), who can be treated within 4.5 to 48 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14(the injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours), combined with Acetylsalicylic acid (Aspirin) at a dose of 100 mg/d for 90 days;2) the other group will receive the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 3 visits including the day of randomization, Day 14±2days and Day 90±7days. The trial is anticipated to complete in 10 months from the first subject recruitment , with 70 subjects recruited. A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine

Official Title
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Antiplatelet Effect of Ginkgo Diterpene Lactone Meglumine Injection in Acute Ischemic Stroke:A Randomized, Double-blind, Placebo-controlled Clinical Trial

Conditions
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Ischemic Stroke

Intervention / Treatment
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* Drug: Ginkgo Diterpene Lactone Meglumine Injection
* Drug: Acetylsalicylic acid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of AIS within 4.5-48 h of symptom onset; Age >40 years, and gender not limited; A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS); Written informed consent was available before enrolment. Exclusion Criteria: Cardiogenic cerebral embolism; AIS caused by other definite causes (e.g., arterial dissection, vasculitis, vascular malformation, etc.) or undetermined etiology; Treated with thrombolysis or intravascular therapy, or with arteriovenous bridging after onset; Under dual antiplatelet therapy or anticoagulant therapy; A score of more than 2 on the modified Rankin Scale (mRS) (scores range from 0 [no symptoms] to 6 [death]) before the occurrence of AIS; Allergy or contraindication to GDLI or aspirin; Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT > 2 times the upper limit of normal), or renal failure (the serum level of creatinine > 1.5 times the upper limit of normal or GFR < 40 ml/min/1.73m2); Anticipated requirement for long-term nonstudy antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function; Severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months; Planned surgery or interventional treatment requiring cessation of the study drug; Pregnancy, lactation, or planning to get pregnant.

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ginkgo and aspirin<br>Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14. The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours;combined with Acetylsalicylic acid (Aspirin) given at a dose of 100 mg per day for 90 days. | Drug: Ginkgo Diterpene Lactone Meglumine Injection<br>* The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.<br>* Other names: YinxingErtieneizhiPu'an Zhusheye;Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.<br>* Other names: Aspirin;|
| Placebo Comparator: aspirin<br>Patients in the aspirin group received the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days. | Drug: Acetylsalicylic acid<br>* Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.<br>* Other names: Aspirin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with NIHSS scores or NIHSS scores | Proportion of patients with National Institutes of Health Stroke Score (NIHSS) scores decrease ≥5 (Δ ≥ 5) or Modified Rankin Scale (mRS) scores decrease ≥2(Δ ≥ 2) from baseline to randomized 90 days. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PL-11 AA at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid. | 24 hours,14 days | 
| PL-11 ADP at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate. | 24 hours,14 days | 
| New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage) | 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. | 14 days | 
| PL-11 COL at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of collagen. | 24 hours,14 days | 
| PL-11 EPI at 24 hours and day 14 | Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of epinephrine. | 24 hours,14 days |