Acute Ischemic StrokePIONEERNCT06861426
Effectiveness of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke
An observational study of Acute Ischemic Stroke, run by Ying Gao at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- Ginkgo Diterpene Lactone Meglumine
- Type of treatment
- Injection or infusion
- How many people
- 4,460 participants
- Where
- 10 sitesChina
- Study dates
- 1 Mar 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: AIS patients within 48 hours of symptom onset from certified stroke centers across China
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
The First Hospital of Jilin University
Changchun, Jilin, 130000
Xin Sun, +86-13596116866, sjnksunxin@163.com
Harbin Second Hospital
Harbin, Heilongjiang, 150000
Youwen Hou, +86-18645001271, hou0422@163.com
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Xueling Ma, +86-15046668187, marlenexl@163.com
Affiliated Hospital of Jining Medical University
Jining, Shandong, 272000
Daojing Li, +86-18553770506, lidaojing0415@163.com
Gansu Provincial People's Hospital
Lanzhou, Gansu, 730000
Yamin Zhang, +86-13619346412, yamin309@163.com
Jiangsu Geriatric Hospital
Nanjing, Jiangsu, 210000
Huifen Zheng, +86-13357818755, zhenghuifen@163.com
Jiangsu Provincial Hospital of Traditional Chinese Medicine
Nanjing, Jiangsu, 210000
Minghua Wu, +86-13951786719, mhuawu@163.com
Xian Changan District Hospital
Xian, Shanxi, 710000
Xianjun Hao, +86-13488116665, 1581270512@qq.com
Xuzhou Hospital of Traditional Chinese Medicine
Xuzhou, Jiangsu, 221000
Jiangfeng Shi, +86-15952260819, 2206777257@qq.com
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000
Chao Jiang, +86-13783538665, chaojzzu@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Acute Ischemic Stroke
- Being tested
- Ginkgo Diterpene Lactone Meglumine
- Keywords
- Ginkgo Diterpene Lactone Meglumine, Acute Ischemic Stroke, Real-World Study, Registry, Effectiveness
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ginkgo Diterpene Lactone MeglumineDrug
Also called Ginkgo Diterpene Lactone Meglumine Injection, Diterpene Ginkgolides Meglumine Injection
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).
| Study group | Role | What they receive |
|---|---|---|
| GDLM group | AIS patients received GDLM and guideline-standardized treatment within 48 hours of symptom onset Receives: Drug: Ginkgo Diterpene Lactone Meglumine | |
| Non-exposed Group | AIS patients initiated guideline-standardized treatment within 48 hours of symptom onset without exposure to Ginkgo-derived preparations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: on day 90 after onset
Secondary outcomes (5)
Proportion of patients with an mRS score of 2 or less
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)
Measured: on day 90 after onset
Distribution of mRS scores
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)
Measured: on day 90 after onset
Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)
Measured: within 90 days after onset
Mortality rate
Measured: within 90 days after onset
Incidence of severe or moderate bleeding events (as defined by GUSTO criteria)
Measured: during hospital stay (up to 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Sep 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 4,460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ying Gao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ying Gao, Dongzhimen Hospital, Beijing
- Investigators
- Ying Gao, PHD, Principal investigator, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06861426
- Sponsor's protocol ID
- 2024-DZMEC-606-01
- Other IDs
- 2022YFC3501104
- Acronym
- PIONEER
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients with Acute Ischemic Stroke Receiving Ginkgo Diterpene Lactone Meglumine: a Patient Registry
- ClinicalTrials.gov ID
- NCT06861426
- Acronym / sponsor ID
- PIONEER / 2024-DZMEC-606-01
- Conditions
- Acute Ischemic Stroke
- Keywords
- Ginkgo Diterpene Lactone Meglumine, Acute Ischemic Stroke, Real-World Study, Registry, Effectiveness
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 4,460 participants (estimated)
- Lead sponsor
- Ying GaoUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDLM group | – | Drug: Ginkgo Diterpene Lactone MeglumineAIS 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- AIS patients within 48 hours of symptom onset from certified stroke centers across China
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginkgo Diterpene Lactone MeglumineAlso: Ginkgo Diterpene Lactone Meglumine Injection, Diterpene Ginkgolides Meglumine InjectionThe 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). | Drug | GDLM group |
Primary outcome
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)
5 secondary outcomes
Proportion of patients with an mRS score of 2 or less
Time frame: on day 90 after onset
Distribution of mRS scores
Time frame: on day 90 after onset
Incidence of new-onset stroke events (ischemic stroke or hemorrhagic stroke)
Time frame: within 90 days after onset
Mortality rate
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Gao, PHD principal investigator
Dongzhimen Hospital, Beijing
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Ischemic Stroke, run by Ying Gao at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sijin Wang, PHD (+86-17812051019, 20230941128@bucm.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with an mRS score of 0 or 1 (time frame: on day 90 after onset). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.