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

March 4, 2025 updated by: Ying Gao

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

4460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Gansu
      • Lanzhou, Gansu, China, 730000
        • Gansu Provincial People's Hospital
        • Contact:
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150000
        • The Fourth Affiliated Hospital of Harbin Medical University
        • Contact:
      • Harbin, Heilongjiang, China, 150000
        • Harbin Second Hospital
        • Contact:
    • Henan
      • Zhengzhou, Henan, China, 450000
        • Henan Provincial People's Hospital
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Geriatric Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210000
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Xuzhou Hospital of Traditional Chinese Medicine
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130000
        • The First Hospital of Jilin University
        • Contact:
    • Shandong
      • Jining, Shandong, China, 272000
        • Affiliated Hospital of Jining Medical University
        • Contact:
    • Shanxi
      • Xian, Shanxi, China, 710000
        • Xian Changan District Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

AIS patients within 48 hours of symptom onset from certified stroke centers across China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GDLM group
AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset
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).
Other Names:
  • Ginkgo Diterpene Lactone Meglumine Injection
  • Diterpene Ginkgolides Meglumine Injection
Non-exposed Group
AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
on day 90 after onset

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
on day 90 after onset
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)
on day 90 after onset
Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)
Time Frame: within 90 days after onset
within 90 days after onset
Mortality rate
Time Frame: within 90 days after onset
within 90 days after onset
Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)
Time Frame: during hospital stay (up to 14 days)
during hospital stay (up to 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ying Gao

Investigators

  • Principal Investigator: Ying Gao, PHD, Dongzhimen Hospital, Beijing

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-DZMEC-606-01
  • 2022YFC3501104 (Other Grant/Funding Number: Ministry of Science and Technology of the People´s Republic of China)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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