The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic Stroke

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Yueyang Integrated Medicine Hospital
• Treatments: Aspirin

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.