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

July 12, 2023 updated by: Shanghai Yueyang Integrated Medicine Hospital

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 70 patients with acute ischemic stroke (5<NIHSS < 24), 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 was diluted with 250ml physiological saline,intravenous drip for about 3 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. The trial is anticipated to complete in 10 months from the first subject recruitment , with 70 subjects recruited. 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

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chunxiang Chen, Master of Medicine
  • Phone Number: +8618616537797
  • Email: 768449109@qq.com

Study Locations

  • China
      • Shanghai, China
        • Recruiting
        • Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: aspirin
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
Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.
Other Names:
  • Aspirin
Active Comparator: Ginkgo and aspirin
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: Acetylsalicylic acid
Acetylsalicylic acid (Aspirin) given at a dose of 100 mg/d for 90 days.
Other Names:
  • Aspirin
Drug: Ginkgo Diterpene Lactone Meglumine Injection
The injection was diluted with 250ml physiological saline,intravenous drip for about 3 hours.
Other Names:
  • YinxingErtieneizhiPu'an Zhusheye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of subjects with NIHSS scores or NIHSS scores
Time Frame: 90 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
Time Frame: 14 days
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
PL-11 AA at 24 hours and day 14
Time Frame: 24 hours,14 days
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of acetylsalicylic acid.
24 hours,14 days
PL-11 ADP at 24 hours and day 14
Time Frame: 24 hours,14 days
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of adenosine diphosphate.
24 hours,14 days
PL-11 COL at 24 hours and day 14
Time Frame: 24 hours,14 days
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of collagen.
24 hours,14 days
PL-11 EPI at 24 hours and day 14
Time Frame: 24 hours,14 days
Residual platelet reactivity detected by PL Platelet Analyser (SINNOWA®)using the inducer of epinephrine.
24 hours,14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Yueyang Integrated Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

October 1, 2023

Study Completion (Estimated)

November 1, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 8, 2022

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 12, 2023

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jm137312ccx

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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