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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ying Gao

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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