Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
PIONEER
Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
2 other identifiers
observational
4,460
1 country
10
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Shorter than P25 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedFirst Posted
Study publicly available on registry
March 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedMarch 6, 2025
March 1, 2025
7 months
February 27, 2025
March 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of patients with an mRS score of 0 or 1
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 Outcomes (5)
Proportion of patients with an mRS score of 2 or less
on day 90 after onset
Distribution of mRS scores
on day 90 after onset
Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)
within 90 days after onset
Mortality rate
within 90 days after onset
Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)
during hospital stay (up to 14 days)
Study Arms (2)
GDLM group
AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset
Non-exposed Group
AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations.
Interventions
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).
Eligibility Criteria
AIS patients within 48 hours of symptom onset from certified stroke centers across China
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ying Gaolead
Study Sites (10)
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000, China
Harbin Second Hospital
Harbin, Heilongjiang, 150000, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
Jiangsu Geriatric Hospital
Nanjing, Jiangsu, 210000, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210000, China
Xuzhou Hospital of Traditional Chinese Medicine
Xuzhou, Jiangsu, 221000, China
The First Hospital of Jilin University
Changchun, Jilin, 130000, China
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000, China
Xian Changan District Hospital
Xian, Shanxi, 710000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ying Gao, PHD
Dongzhimen Hospital, Beijing
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- OTHER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 6, 2025
Study Start
March 1, 2025
Primary Completion
September 30, 2025
Study Completion
December 31, 2025
Last Updated
March 6, 2025
Record last verified: 2025-03