Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ginkgo Diterpene Lactone Meglumine.
- Who it may be relevant to
- Registry conditions: Acute Ischemic Stroke. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
Overview
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.
Detailed description
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.
Interventions
- Drug 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).
Primary outcome measures
- Proportion of patients with an mRS score of 0 or 1 [Time frame: on day 90 after onset]
Secondary outcome measures (5)
- Proportion of patients with an mRS score of 2 or less [Time frame: on day 90 after onset]
- Distribution of mRS scores [Time frame: on day 90 after onset]
- Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke) [Time frame: within 90 days after onset]
- Mortality rate [Time frame: within 90 days after onset]
- Incidence of severe or moderate bleeding events (as defined by GUSTO criteria) [Time frame: during hospital stay (up to 14 days)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 10 centers
- Gansu Provincial People's Hospital — Lanzhou
- Harbin Second Hospital — Harbin
- The Fourth Affiliated Hospital of Harbin Medical University — Harbin
- Henan Provincial People's Hospital — Zhengzhou
- Jiangsu Geriatric Hospital — Nanjing
- Jiangsu Provincial Hospital of Traditional Chinese Medicine — Nanjing
- Xuzhou Hospital of Traditional Chinese Medicine — Xuzhou
- The First Hospital of Jilin University — Changchun
- … and 2 more centers
Identifiers
NCT: NCT06861426 · 2024-DZMEC-606-01 · 2022YFC3501104