Clinical trial NCT06861426: Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
Official title: Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Ischemic Stroke
Keywords: Ginkgo Diterpene Lactone Meglumine
Acute Ischemic Stroke
Real-World Study
Registry
Effectiveness
Lead sponsor: Dongzhimen Hospital, Beijing
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 4460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: AIS patients within 48 hours of symptom onset from certified stroke centers across China

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.

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

Primary outcomes:
measure: Proportion of patients with an mRS score of 0 or 1
timeFrame: on day 90 after onset
Secondary outcomes:
measure: Proportion of patients with an mRS score of 2 or less
timeFrame: on day 90 after onset
measure: Distribution of mRS scores
timeFrame: on day 90 after onset
measure: Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)
timeFrame: within 90 days after onset
measure: Mortality rate
timeFrame: within 90 days after onset
measure: Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)
timeFrame: during hospital stay (up to 14 days)
Other outcomes:
Locations:
city: Lanzhou
country: China
facility: Gansu Provincial People's Hospital
state: Gansu
city: Harbin
country: China
facility: Harbin Second Hospital
state: Heilongjiang
city: Harbin
country: China
facility: The Fourth Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Geriatric Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Hospital of Traditional Chinese Medicine
state: Jiangsu
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University
state: Shandong
city: Xian
country: China
facility: Xian Changan District Hospital
state: Shanxi
Study officials:
affiliation: Dongzhimen Hospital, Beijing
name: Ying Gao, PHD
role: PRINCIPAL_INVESTIGATOR
References: