Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,460
- 试验地点
- 10
- 主要终点
- Proportion of patients with an mRS score of 0 or 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
GDLM group
AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset
干预措施: Ginkgo Diterpene Lactone Meglumine (Drug)
结局指标
主要结局
Proportion of patients with an mRS score of 0 or 1
时间窗: 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)
次要结局
- Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)(within 90 days after onset)
- Proportion of patients with an mRS score of 2 or less(on day 90 after onset)
- Distribution of mRS scores(on day 90 after onset)
- Mortality rate(within 90 days after onset)
- Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)(during hospital stay (up to 14 days))
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing