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

NCT05531942 | Unknown Phase 2

• 1 other identifier: jm137312ccx
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Ischemic Stroke

Outcome Measures

Primary Outcomes (1)

• Proportion 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.

  90 days

Secondary Outcomes (5)

• PL-11 AA at 24 hours and day 14

  24 hours,14 days

• PL-11 ADP at 24 hours and day 14

  24 hours,14 days

• New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)

  14 days

• PL-11 COL at 24 hours and day 14

  24 hours,14 days

• PL-11 EPI at 24 hours and day 14

  24 hours,14 days

Study Arms (2)

Ginkgo and aspirin

ACTIVE COMPARATOR

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) given at a dose of 100 mg per day for 90 days.

Drug: Ginkgo Diterpene Lactone Meglumine Injection; Drug: Acetylsalicylic acid

aspirin

PLACEBO COMPARATOR

Patients in the aspirin group received the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.

Drug: Acetylsalicylic acid

Interventions

Ginkgo Diterpene Lactone Meglumine Injection DRUG

The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.

Also known as: YinxingErtieneizhiPu'an Zhusheye

Ginkgo and aspirin

Acetylsalicylic acid DRUG

Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.

Also known as: Aspirin

Ginkgo and aspirin; aspirin

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Yueyang Integrated Medicine Hospital: lead

Study Sites (1)

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

Chunxiang Chen, Master of Medicine

CONTACT

+8618616537797; 768449109@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 8, 2022
• Study Start: January 1, 2021
• Primary Completion: October 1, 2023
• Study Completion: November 1, 2023
• Last Updated: July 14, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)