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

NCT ID: NCT05663307

Last Updated: 2022-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-01

Brief Summary

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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

Detailed Description

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This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age \> 40 years) with acute ischemic stroke (5\<NIHSS \< 25), 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 must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 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.After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke.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.

Conditions

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Ischemic Stroke, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Ginkgo diterpene lactone meglumine injection

Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days.

Group Type ACTIVE_COMPARATOR

Ginkgo diterpene lactone meglumine injection

Intervention Type DRUG

Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.

Aspirin

Intervention Type DRUG

plus aspirin at a dose of 100 mg per day for 90 days.

Ginkgo diterpene lactone meglumine injection simulation

Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days.

Group Type PLACEBO_COMPARATOR

Ginkgo diterpene lactone meglumine injection simulation

Intervention Type DRUG

Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.

Aspirin

Intervention Type DRUG

plus aspirin at a dose of 100 mg per day for 90 days.

Interventions

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Ginkgo diterpene lactone meglumine injection

Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.

Intervention Type DRUG

Ginkgo diterpene lactone meglumine injection simulation

Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.

Intervention Type DRUG

Aspirin

plus aspirin at a dose of 100 mg per day for 90 days.

Intervention Type DRUG

Other Intervention Names

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YinxingErtieneizhiPu'an Zhusheye YinxingErtieneizhiPu'an Zhusheye simulation Acetylsalicylic acid

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Yueyang Integrated Medicine Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan Han, Ph.D.

Role: STUDY_DIRECTOR

Shanghai University of Traditional Chinese Medicine

Locations

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

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunxiang Chen, M.D.

Role: CONTACT

Phone: +8618616537797

Email: [email protected]

Facility Contacts

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Yan Han, Ph.D.

Role: primary

Other Identifiers

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No.2020-134

Identifier Type: -

Identifier Source: org_study_id