Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

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

NOT_YET_RECRUITING

Total Enrollment

4460 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-01

Study Completion Date

2025-12-31

Brief Summary

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The primary purpose of this study is to investigate the effectiveness of Ginkgo Diterpene Lactone Meglumine (GDLM) for patients with acute ischemic stroke (AIS) in real-world settings.

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Detailed Description

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The randomized controlled trial (RCT) of GDLM for the treatment of AIS was published in JAMA Network Open, titled "Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial." This study provided valuable insights into the efficacy and safety of GDLM in improving functional recovery for patients with AIS. However, the generalizability of these findings to real-world medical settings remains unclear, as the trial was conducted under controlled conditions that may not fully reflect routine clinical practice. To address this gap, we will conduct this study to further explore the effectiveness of GDLM in a real medical environment. Using routine clinical care data for real-world evidence, we aim to investigate the treatment's impact on a broader and more diverse patient population. This approach will allow us to better understand the practical application of GDLM in everyday clinical settings, including its potential benefits and challenges when used outside the confines of a RCT.

Conditions

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Acute Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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GDLM group

AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset

Ginkgo Diterpene Lactone Meglumine

Intervention Type DRUG

The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs).

Non-exposed Group

AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations.

No interventions assigned to this group

Interventions

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Ginkgo Diterpene Lactone Meglumine

The specific administration protocol (including time of initiation, dosage, and treatment duration) should be strictly adhered to as per the physician's prescription and meticulously documented in the case report forms (CRFs).

Intervention Type DRUG

Other Intervention Names

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Ginkgo Diterpene Lactone Meglumine Injection Diterpene Ginkgolides Meglumine Injection

Eligibility Criteria

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Inclusion Criteria

* aged ≥18 years, regardless of gender
* within 48 hours of stroke onset of ischemic stroke
* patient or their legally authorized representative (LAR) has signed informed consent or legally authorized oral consent with documentation

Exclusion Criteria

* mRS score of 2 or more prior to onset
* total hospital stay less than 7 days
* use of other ginkgo-derived preparations except GDLM
* current or planned participation in any other interventional clinical trials
* inability to comply with study procedures due to documented psychiatric disorders or severe cognitive impairment

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No