Ischemic StrokePhase 2NCT02526225
A Safety and Effective Study of Ginkgolides Diterpene Lactone Meglumine Injection in the Treatment of Ischemic Stroke.
A Phase 2 study testing Ginkgo diterpene lactone meglumine injection and Ginkgo diterpene lactone meglumine injection simulation in people with Ischemic Stroke, run by Beijing Tiantan 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 18 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Ginkgo diterpene lactone meglumine injection and Ginkgo diterpene lactone meglumine injection simulation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3,452 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2016to 31 Aug 2019
- Phase
- Phase 2
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 80 years of age, and gender not limited。
- Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
- The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher;
- Understand and voluntarily signed informed consent.
Who cannot join
- Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
- With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
- Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5);
- A history of mental illness or dementia patients;
- Severe organ or other systemic disease, accompanied by any organ or system of malignant tumor, or ongoing anti-tumor treatment, the estimated lifetime < 3 months;
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- Significant drug or alcohol abuse;
- Allergic constitution, as well as to two or more drugs or food allergies;This medicine ingredients allergy or known;
- Have pregnancy (check blood HCG positive screening tests, namely HCG > 5 miu/mL), during the test preparation is pregnancy or lactation in women;
- In the past three months in other clinical trials;
- Researchers do not determine poor adherence, or any other suitable for patients to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.
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
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
- Conditions
- Ischemic Stroke
- Being tested
- Ginkgo diterpene lactone meglumine injection, Ginkgo diterpene lactone meglumine injection simulation
- Keywords
- acute ischemic stroke, safety and effectiveness, Ginkgo diterpene lactone meglumine injection
- 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
5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
Ginkgo diterpene lactone meglumine injection simulationDrug
5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
| Study group | Role | What they receive |
|---|---|---|
| ginkgo diterpene lactone meglumine injection | Active comparator | ginkgo diterpene lactone meglumine injection Receives: Drug: Ginkgo diterpene lactone meglumine injection |
| Ginkgo diterpene lactone meglumine injection simulation | Placebo comparator | Ginkgo diterpene lactone meglumine injection simulation Receives: Drug: Ginkgo diterpene lactone meglumine injection simulation |
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) less than or equal to 1 .
Measured: 90 days
Secondary outcomes (8)
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days.
Measured: Baseline, 7days
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days.
Measured: Baseline,7 days,14 days,
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
Measured: 90 days
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
Measured: Baseline,14 days,90 days
The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.
Measured: Baseline,14 days,90 days
The all-cause mortality
Measured: 90 days
Ischemic stroke recurrence rate
Measured: 90 days
Composite incidence of vascular events
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 posted18 Aug 2015 (estimated)
- Study start1 Feb 2016
- Primary completion1 May 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Beijing Tiantan HospitalThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 3,452 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Tiantan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Responsible party
- Principal investigator, Yongjun Wang, Beijing Tiantan Hospital
- Investigators
- yongjun wang, M.D., Principal investigator, Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02526225
- Sponsor's protocol ID
- 1412-Z-YXET-ZS-RE
- Status last verified
- Mar 2023
- First submitted
- 5 Aug 2015
- Last updated
- 30 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tian X, Xu Q, Xia X, Zhang Y, Zhao X, Wang A. Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. Health Qual Life Outcomes. 2024 Nov 15;22(1):99. doi: 10.1186/s12955-024-02315-1.
PubMed 39548582Zhang Q, Wang A, Xu Q, Xia X, Tian X, Zhang Y, Li X, Yang X, Wang X, Peng J, Li Y, Liu L, Jin S, Meng X, Zhao X; GDLM group. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828. doi: 10.1001/jamanetworkopen.2023.28828.
PubMed 37578791
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double Blind,Placebo Parallel Controlled,Multicenter Clinical Sthdy of Ginkgo Diterpene Lactone Meglumine Injection for Acute Ischemic Stroke Efficacy Safety.
- ClinicalTrials.gov ID
- NCT02526225
- Acronym / sponsor ID
- 1412-Z-YXET-ZS-RE
- Conditions
- Ischemic Stroke
- Keywords
- acute ischemic stroke, safety and effectiveness, Ginkgo diterpene lactone meglumine injection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,452 participants (actual)
- Lead sponsor
- Beijing Tiantan HospitalUniversity, hospital or other
- Collaborators
- Beijing Bionovo Medicine Development Co., Ltd.
- Study start
- 1 Feb 2016
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 18 Aug 2015 (estimated)
- 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
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginkgo diterpene lactone meglumine injection | Active comparator | Drug: Ginkgo diterpene lactone meglumine injectionginkgo diterpene lactone meglumine injection |
| Ginkgo diterpene lactone meglumine injection simulation | Placebo comparator | Drug: Ginkgo diterpene lactone meglumine injection simulationGinkgo diterpene lactone meglumine injection simulation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 18 to 80 years of age, and gender not limited。
- Within 48 hours of stroke onset of ischemic stroke (diagnosis standard by the Chinese medical association of the fourth national conference on cerebrovascular disease);
- The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- The degree of nerve function defect score (NIHSS) score 4 to 24 points, body movement component (NIHSS score paragraphs 5 and 6) total score 2 points or higher;
- Understand and voluntarily signed informed consent.
Key exclusion criteria (11 listed)
- Head imaging studies have confirmed that, encephalitis, brain tumor, brain abscess and cause similar symptoms of disease, or confirm with hemorrhagic cerebral infarction, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc.
- The serious disturbance of consciousness (Ia NIHSS score 2 points or higher);
- With hemorrhagic disease or have a bleeding tendency, or have a lower limb venous thrombosis;
- Serious abnormal liver and kidney function, liver function laboratory indexes of ALT > 3 ULN, renal laboratory ULN Cr > 1.5);
- A history of mental illness or dementia patients;
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 injection5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip. | Drug | ginkgo diterpene lactone meglumine injection |
| Ginkgo diterpene lactone meglumine injection simulation5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip. | Drug | Ginkgo diterpene lactone meglumine injection simulation |
Primary outcome
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 .
Time frame: 90 days
8 secondary outcomes
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) rising 4 or more points, three points, two points, one of the subjects changes from baseline to randomized 7 days.
Time frame: Baseline, 7days
Proportion of patients with National Institutes of Health Stroke Score (NIHSS) reducing 4 points or more changes from baseline to randomized 7 days,14 days.
Time frame: Baseline,7 days,14 days,
Proportion of patients with Modified Rankin Scale (mRS) reaching 0-2 .
Time frame: 90 days
The Montreal Cognitive Assessment (MoCA) scale changes from baseline to randomized 14 days,90 days.
Time frame: Baseline,14 days,90 days
The EuroQol-5 Dimensions (EQ-5D) scale changes from baseline to randomized 14 days,90 days.
Time frame: Baseline,14 days,90 days
The all-cause mortality
Time frame: 90 days
Ischemic stroke recurrence rate
Time frame: 90 days
Composite incidence of vascular events
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2023.
- Derived from this study: PubMed 39548582Tian X, Xu Q, Xia X, Zhang Y, Zhao X, Wang A. Effect of ginkgo diterpene lactone meglumine on the quality of life in patients with acute ischemic stroke. Health Qual Life Outcomes. 2024 Nov 15;22(1):99. doi: 10.1186/s12955-024-02315-1.
- Derived from this study: PubMed 37578791Zhang Q, Wang A, Xu Q, Xia X, Tian X, Zhang Y, Li X, Yang X, Wang X, Peng J, Li Y, Liu L, Jin S, Meng X, Zhao X; GDLM group. Efficacy and Safety of Ginkgo Diterpene Lactone Meglumine in Acute Ischemic Stroke: A Randomized Clinical Trial. JAMA Netw Open. 2023 Aug 1;6(8):e2328828. doi: 10.1001/jamanetworkopen.2023.28828.
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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. This study is not recruiting at the moment.
yongjun wang, M.D. principal investigator
Beijing Tiantan Hospital,Capital Medical University,Bgeijing,China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ginkgo diterpene lactone meglumine injection and Ginkgo diterpene lactone meglumine injection simulation in people with Ischemic Stroke, run by Beijing Tiantan 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: finished, as of the sponsor's last update on 30 Mar 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 . (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02526225, which also lists 2 linked publications.
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 30 Mar 2023.