Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

Not yet recruiting

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: Ginkgo Diterpene Lactone Meglumine

• Registration Number: NCT06861426
• Lead Sponsor: Ying Gao

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.

Study Timeline

• Study First Submitted: 2025-02-27
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Study First Submitted QC: 2025-03-04
• Last Update Submitted: 2025-03-04
• Study First Posted: 2025-03-06
• Last Update Posted: 2025-03-06
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4460

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDLM group	Ginkgo Diterpene Lactone Meglumine	AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)	during hospital stay (up to 14 days)

Trial Locations

Locations (10)

Gansu Provincial People's Hospital; 🇨🇳 Lanzhou, Gansu, China

Harbin Second Hospital; 🇨🇳 Harbin, Heilongjiang, China

The Fourth Affiliated Hospital of Harbin Medical University; 🇨🇳 Harbin, Heilongjiang, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Jiangsu Geriatric Hospital; 🇨🇳 Nanjing, Jiangsu, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine; 🇨🇳 Nanjing, Jiangsu, China

Xuzhou Hospital of Traditional Chinese Medicine; 🇨🇳 Xuzhou, Jiangsu, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Affiliated Hospital of Jining Medical University; 🇨🇳 Jining, Shandong, China

Xian Changan District Hospital; 🇨🇳 Xian, Shanxi, China