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

Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531942
• Other study ID #: jm137312ccx
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: January 1, 2021
• Est. completion date: November 1, 2023

Study information

• Verified date: November 2022
• Source: Shanghai Yueyang Integrated Medicine Hospital
• Contact: Chunxiang Chen, Master of Medicine
• Phone: +8618616537797
• Email: 768449109[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cerebral Infarction
• Ischemia
• Ischemic Stroke
• Stroke

Intervention

Drug:
• Ginkgo Diterpene Lactone Meglumine Injection
The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.
• Acetylsalicylic acid
Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.

Locations

Country	Name	City	State
China	Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Yueyang Integrated Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with NIHSS scores or NIHSS scores	Proportion of patients with National Institutes of Health Stroke Score (NIHSS) scores decrease =5 (? = 5) or Modified Rankin Scale (mRS) scores decrease =2(? = 2) from baseline to randomized 90 days.	90 days
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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