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NCT Number: NCT06861426

Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Gansu Provincial People's Hospital, Lanzhou, Gansu, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ginkgo Diterpene Lactone Meglumine

Drug

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).

Other names: Ginkgo Diterpene Lactone Meglumine Injection, Diterpene Ginkgolides Meglumine Injection

Primary outcomes

  1. Proportion of patients with an mRS score of 0 or 1

    Time frame: 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 outcomes

  1. Proportion of patients with an mRS score of 2 or less

    Time frame: 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)

  2. Distribution of mRS scores

    Time frame: 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)

  3. Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)

    Time frame: within 90 days after onset

  4. Mortality rate

    Time frame: within 90 days after onset

  5. Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)

    Time frame: during hospital stay (up to 14 days)

Study contacts

Contact information is provided by the study sponsor or research team.

Sijin Wang, PHD

CONTACT

[email protected]

+86-17812051019

Sponsors and collaborators

Lead sponsor

Ying Gao

Other

Registry information

Official study title

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

Acronym: PIONEER

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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