Clinical trial NCT05663307: The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic Stroke
Official title: The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Ischemic Stroke, Acute
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke

Detailed description: This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age \> 40 years) with acute ischemic stroke (5\<NIHSS \< 25), 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 must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 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.After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke.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.

Eligibility criteria: Inclusion Criteria:

* Aged \> 40 years, and gender not limited;
* Within 48 hours of stroke onset of ischemic stroke;
* The first onset, or always not obvious legacy of stroke sequela;
* A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS)；
* Understand and voluntarily signed informed consent.

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.

Primary outcomes:
measure: Proportion of patients with Modified Rankin Scale (mRS)
timeFrame: 90 days
Secondary outcomes:
measure: New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
timeFrame: 90 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Study officials:
affiliation: Shanghai University of Traditional Chinese Medicine
name: Yan Han, Ph.D.
role: STUDY_DIRECTOR
References: