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

• Status: Not yet recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

Criteria

Inclusion Criteria:

• Diagnosis of AIS within 4.5-48 h of symptom onset;

• Aged 40 to 80 years of age, 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.