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ClinicalTrials.gov ID

NCT06861426

Lead Sponsor

Ying GaoOTHER

Overall Status

Not yet recruiting

Study Type

Observational

Enrollment

4,460Estimated

Last Update Posted

Mar 6, 2025Actual

Start Date

Mar 1, 2025Estimated

Primary Completion Date

Sep 30, 2025Estimated

Completion Date

Dec 31, 2025Estimated

Official Title

Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry

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.

• Acute Ischemic Stroke

• Ginkgo Diterpene Lactone Meglumine

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Other

Lead Sponsor

Ying GaoOTHER

hou0422@163.com+86-18645001271

zhenghuifen@163.com+86-13357818755