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).
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.
Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai, China
RECRUITINGProportion 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.
Time frame: 90 days
PL-11 AA at 24 hours and day 14
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 24 hours,14 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.