Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke (PIONEER)

Ying Gao

Status: Not yet enrolling

Conditions: Acute Ischemic Stroke

Treatments: Drug: Ginkgo Diterpene Lactone Meglumine

Study type: Observational

Funder types: Other

Identifiers

NCT06861426

2022YFC3501104 (Other Grant/Funding Number)

2024-DZMEC-606-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,460 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

4,460 participants in 2 patient groups

GDLM group

Description:

AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset

Treatment:

Drug: Ginkgo Diterpene Lactone Meglumine

Non-exposed Group

Description:

AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations.