NCT06861426

Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 4,460 (estimated)
• Sponsor: Ying Gao · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	Ginkgo 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).

Timeline

• Start date: 2025-03-01
• Primary completion: 2025-09-30
• Completion: 2025-12-31
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

10 sites across 1 country: China