Acute Ischemic Stroke
Conditions
Keywords
Ginkgo Diterpene Lactone Meglumine, Acute Ischemic Stroke, Real-World Study, Registry, Effectiveness
Brief summary
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
DRUGGinkgo 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).
Sponsors
Ying Gao
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with an mRS score of 0 or 1 | on day 90 after onset | Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe or moderate bleeding events (as defined by GUSTO criteria) | during hospital stay (up to 14 days) | — |
| Proportion of patients with an mRS score of 2 or less | on day 90 after onset | Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome) |
| Distribution of mRS scores | on day 90 after onset | Modified Rankin Scale (mRS) is a 6-point ordinal scale from 0 \[no symptoms\] to 5 \[severe disability\] when excluding mortality, with lower scores indicating better functional outcome) |
| Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke) | within 90 days after onset | — |
| Mortality rate | within 90 days after onset | — |
Countries
China
Contacts
Primary ContactSijin Wang, PHD
Outcome results
None listed