Ischemic Stroke, AcutePhase 2/3NCT05663307
The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic Stroke
A Phase 2/3 study testing Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation and Aspirin in people with Ischemic Stroke, Acute, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site in China.
Trial summary
The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation and Aspirin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 1 Dec 2023
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged > 40 years, and gender not limited;
- Within 48 hours of stroke onset of ischemic stroke;
- The first onset, or always not obvious legacy of stroke sequela;
- A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS)；
- Understand and voluntarily signed informed consent.
Who cannot join
- Cardiogenic cerebral embolism;
- AIS caused by other definite causes (e.g., arterial dissection, vasculitis, vascular malformation, etc.) or undetermined etiology;
- Treated with thrombolysis or intravascular therapy, or with arteriovenous bridging after onset;
- Under dual antiplatelet therapy or anticoagulant therapy;
- A score of more than 2 on the modified Rankin Scale (mRS) (scores range from 0 [no symptoms] to 6 [death]) before the occurrence of AIS;
- Allergy or contraindication to GDLI or aspirin;
Show all 11Show fewer
- Patients with active bleeding or bleeding tendency, malignancies, severe liver (the serum level of AST and/or ALT > 2 times the upper limit of normal), or renal failure (the serum level of creatinine > 1.5 times the upper limit of normal or GFR < 40 ml/min/1.73m2);
- Anticipated requirement for long-term nonstudy antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function;
- Severe noncardiovascular coexisting condition, with a life expectancy of less than 3 months;
- Planned surgery or interventional treatment requiring cessation of the study drug;
- Pregnancy, lactation, or planning to get pregnant.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine
Shanghai
Yan Han, Ph.D., +86 189-1751-0069, hanyan@shutcm.edu.cn
About this study
Official title: The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study
The aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
Read the detailed description
This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age > 40 years) with acute ischemic stroke (5<NIHSS < 25), who can be treated within 4.5 to 48 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14（the injection must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 hours）, combined with Acetylsalicylic acid (Aspirin) at a dose of 100 mg/d for 90 days;2) the other group will receive the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 3 visits including the day of randomization, Day 14±2days and Day 90±7days.After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke.A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation, Aspirin
- 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 meglumine injectionDrug
Also called YinxingErtieneizhiPu'an Zhusheye
Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
Ginkgo diterpene lactone meglumine injection simulationDrug
Also called YinxingErtieneizhiPu'an Zhusheye simulation
Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days.
AspirinDrug
Also called Acetylsalicylic acid
plus aspirin at a dose of 100 mg per day for 90 days.
| Study group | Role | What they receive |
|---|---|---|
| Ginkgo diterpene lactone meglumine injection | Active comparator | Intravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days. Receives: Drug: Ginkgo diterpene lactone meglumine injection; Drug: Aspirin |
| Ginkgo diterpene lactone meglumine injection simulation | Placebo comparator | Intravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days. Receives: Drug: Ginkgo diterpene lactone meglumine injection simulation; Drug: Aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Modified Rankin Scale (mRS)
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . The mRS scores range from 0 to 6, ranging from perfect health without symptoms to death
Measured: 90 days
Secondary outcomes (1)
New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
All the new vascular events will be assessed by at least two neurologists based on neuroimaging and clinical feature. When there was disagreement, a third senior neurologist was consulted to reach a consensus decision.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start1 Jan 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Stroke, AcuteStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Yueyang Integrated Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Han, Ph.D., Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663307
- Sponsor's protocol ID
- No.2020-134
- Status last verified
- Dec 2022
- First submitted
- 15 Dec 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Ginkgolide on Clinical Improvement of Patients With Acute Ischemic: A Randomized, Double Blind, Placebo Parallel Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT05663307
- Acronym / sponsor ID
- No.2020-134
- Conditions
- Ischemic Stroke, Acute
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai Yueyang Integrated Medicine HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 23 Dec 2022 (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 aim of this study is to evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke
Detailed description
This trial is a randomized, double-blind, placebo-controlled trial, A total of approximately 80 patients (age > 40 years) with acute ischemic stroke (5<NIHSS < 25), who can be treated within 4.5 to 48 hours of symptom onset will be enrolled. Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be randomized 1:1 into two groups after offering informed content: 1) one group will receive a Ginkgo Diterpene Lactone Meglumine Injection 25mg/5ml,once/day from Day 1 to Day 14（the injection must be added slowly into 0.9% sodium chloride injection diluted to 250 ml , intravenous drip for about 2 hours）, combined with Acetylsalicylic acid (Aspirin) at a dose of 100 mg/d for 90 days;2) the other group will receive the same volume saline injection as placebo for 14 days plus aspirin at a dose of 100 mg per day for 90 days.The primary objective is to assess the anti-platelet effects of Ginkgo Diterpene Lactone Meglumine Injection combined with Aspirin versus Aspirin alone in patients with acute ischemic stroke. The study consists of 3 visits including the day of randomization, Day 14±2days and Day 90±7days.After randomized to 90 + 7 days mRS 0-1 points is the Primary Outcome Measure,evaluate the safety and effectivity of Ginkgo diterpene lactone meglumine injection tn the treatment of acute ischemic stroke.A Data and Safety Monitoring Board (DSMB) will regularly monitor safety during the study. The trial has been approved by Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine affiliated to Shanghai University of Traditional Chinese Medicine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginkgo diterpene lactone meglumine injection | Active comparator | Drug: Ginkgo diterpene lactone meglumine injection, Drug: AspirinIntravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days. |
| Ginkgo diterpene lactone meglumine injection simulation | Placebo comparator | Drug: Ginkgo diterpene lactone meglumine injection simulation, Drug: AspirinIntravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days ;Aspirin at a dose of 100 mg per day for 90 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged > 40 years, and gender not limited;
- Within 48 hours of stroke onset of ischemic stroke;
- The first onset, or always not obvious legacy of stroke sequela;
- A score of 5-24 points on the National Institute of Health Stroke Scale (NIHSS)；
- Understand and voluntarily signed informed consent.
Key exclusion criteria (11 listed)
- Cardiogenic cerebral embolism;
- AIS caused by other definite causes (e.g., arterial dissection, vasculitis, vascular malformation, etc.) or undetermined etiology;
- Treated with thrombolysis or intravascular therapy, or with arteriovenous bridging after onset;
- Under dual antiplatelet therapy or anticoagulant therapy;
- A score of more than 2 on the modified Rankin Scale (mRS) (scores range from 0 [no symptoms] to 6 [death]) before the occurrence of AIS;
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 meglumine injectionAlso: YinxingErtieneizhiPu'an ZhusheyeIntravenous injections of Ginkgo diterpene lactone meglumine injection at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days. | Drug | Ginkgo diterpene lactone meglumine injection |
| Ginkgo diterpene lactone meglumine injection simulationAlso: YinxingErtieneizhiPu'an Zhusheye simulationIntravenous injections of Ginkgo diterpene lactone meglumine injection simulation at a dose of 25 mg (5ml) diluted with 250 ml physiological saline for 14 days plus aspirin at a dose of 100 mg per day for 90 days. | Drug | Ginkgo diterpene lactone meglumine injection simulation |
| AspirinAlso: Acetylsalicylic acidplus aspirin at a dose of 100 mg per day for 90 days. | Drug | Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS)
Time frame: 90 days
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . The mRS scores range from 0 to 6, ranging from perfect health without symptoms to death
1 secondary outcome
New vascular events defined as any event of the following: Any stroke (ischemic or hemorrhage)
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
Related trials for Ischemic Stroke, Acute
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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. This study is not recruiting at the moment.
Yan Han, Ph.D. study director
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation and Aspirin in people with Ischemic Stroke, Acute, run by Shanghai Yueyang Integrated Medicine Hospital at 1 site 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 5 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunxiang Chen, M.D. (+8618616537797, 768449109@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) (time frame: 90 days). 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 29 Dec 2022.