StrokeNCT05169450
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
A study testing Diterpene ginkgolides meglumine injection and Ginaton in people with Stroke and Ischemic Stroke, run by Dongzhimen Hospital, Beijing at 1 site in China.
Trial summary
A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Stroke, Ischemic Stroke, Nervous System Diseases
- What is being tested?
- Diterpene ginkgolides meglumine injection and Ginaton
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 998 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2013to 1 Apr 2014
- Phase
- Interventional
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 35 years of age or older, and gender not limited;
- Between 2 and 4 weeks onset of ischemic stroke;
- The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- Understand and voluntarily signed informed consent.
Who cannot join
- Known severe liver or kidney dysfunction;
- Known allergies for ingredients in the investigational product;
- Known medical condition likely to limit survival to less than 3 months;
- Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;
- Hemorrhage transformation after infarction, or bleeding tendency;
- Pregnancy or breastfeeding;
- Known lower extremity venous thrombosis;
- Having participated in others clinical trial within 1 month before randomization.
Trial locations and contacts
1 site in 1 country.
China1 site
Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, 100700
About this study
Official title: Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.
Read the detailed description
To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups. The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients. Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged < 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.
- Conditions
- Stroke, Ischemic Stroke, Nervous System Diseases, Cerebral Infarction, Brain Ischemia, Brain Infarction
- Being tested
- Diterpene ginkgolides meglumine injection, Ginaton
- Keywords
- Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness
- Medical subject headings
- Stroke, Ischemic Stroke, Nervous System Diseases, Cerebral Infarction, Brain Ischemia, Brain Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diterpene ginkgolides meglumine injectionDrug
Also called Ginkgolides Diterpene Lactone Meglumine Injection
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
GinatonDrug
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.
| Study group | Role | What they receive |
|---|---|---|
| Diterpene ginkgolides meglumine injection | Experimental | The intervention group received daily single infusions of 25 mg diterpene ginkgolides meglumine injection (DGMI) diluted with 250 ml of 0.9% sodium chloride injection for 14 days. Receives: Drug: Diterpene ginkgolides meglumine injection |
| Ginaton | Active comparator | The control group received once or twice a day infusion of 35-60mg Ginaton diluted with 250 ml of 0.9% sodium chloride injection for 14 days. Receives: Drug: Ginaton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excellent functional outcome
Excellent functional outcome defined as an Modified Rankin Scale (mRS) score ≤ 1 at 90 days(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death)
Measured: 90 days
Secondary outcomes (2)
Neurological deficit amelioration
neurological deficit amelioration, which was defined as a change in the National Institutes of Health Stroke Scale (NIHSS) score (range = 0-42, with higher scores indicating more severe strokes) from baseline to D14
Measured: 14 post-randomization days, 90days
Patient quality of life
Patient quality of life, as measured using the EuroQol questionnaire [consisting of two parts: EuroQol-5 Dimension(EQ-5D) and EQ visual analog scale (EQ-VAS)]. A value of 100 on this scale indicates a perfect score for health, whereas a score of 0 indicates death. The EQ-5D index score is measured on a scale of 0 (death) to 1 (full health).
Measured: 14 post-randomization days, 90days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Jul 2013
- Primary completion1 Apr 2014
- Study completion1 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dongzhimen Hospital, Beijing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ying Gao, Dongzhimen Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169450
- Sponsor's protocol ID
- TJ2013012
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- 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 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05169450
- Acronym / sponsor ID
- TJ2013012
- Conditions
- Stroke, Ischemic Stroke, Nervous System Diseases, Cerebral Infarction, Brain Ischemia, Brain Infarction
- Keywords
- Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Dongzhimen Hospital, BeijingUniversity, hospital or other
- Study start
- 1 Jul 2013 (actual)
- Primary completion
- 1 Apr 2014 (actual)
- Study completion
- 1 Apr 2014 (actual)
- First posted
- 27 Dec 2021 (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.
A randomized positived-controlled study of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) was conducted between7/2013 and 4/2014. The study was designed to test efficacy of DGMI for IS. Post hoc analysis of this trial was conducted to evaluate the efficacy of DGMI in elderly (aged≥65 years) IS patients.
Detailed description
To examine the efficacy of Diterpene Ginkgolides Meglumine Injection (DGMI) vs Ginaton in patients with ischemic stroke (IS) by age subgroups. The efficacy analysis was a post hoc analysis of data from a large randomized, controlled study was performed in a cohort of 998 IS patients. Patients were pooled and grouped by age (elderly aged ≥ 65 years and non-elderly aged < 65 years).Proportion of patients with Modified Rankin Scale (mRS) less than or equal to 1 at 90days is the primary outcome measure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diterpene ginkgolides meglumine injection | Experimental | Drug: Diterpene ginkgolides meglumine injectionThe intervention group received daily single infusions of 25 mg diterpene ginkgolides meglumine injection (DGMI) diluted with 250 ml of 0.9% sodium chloride injection for 14 days. |
| Ginaton | Active comparator | Drug: GinatonThe control group received once or twice a day infusion of 35-60mg Ginaton diluted with 250 ml of 0.9% sodium chloride injection for 14 days. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 35 years of age or older, and gender not limited;
- Between 2 and 4 weeks onset of ischemic stroke;
- The first onset, or always not obvious legacy of stroke sequela (mRS acuities were before the onset of 1);
- Understand and voluntarily signed informed consent.
Key exclusion criteria (8 listed)
- Known severe liver or kidney dysfunction;
- Known allergies for ingredients in the investigational product;
- Known medical condition likely to limit survival to less than 3 months;
- Known dementia, mental impairment, or unsuitability for participation as judged by the investigators;
- Hemorrhage transformation after infarction, or bleeding tendency;
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 |
|---|---|---|
| Diterpene ginkgolides meglumine injectionAlso: Ginkgolides Diterpene Lactone Meglumine InjectionPatients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care. | Drug | Diterpene ginkgolides meglumine injection |
| GinatonPatients will receive intravenously administered Ginaton, combined with guidelines-based standard care. | Drug | Ginaton |
Primary outcome
Excellent functional outcome
Time frame: 90 days
Excellent functional outcome defined as an Modified Rankin Scale (mRS) score ≤ 1 at 90 days(scores ranged from 0 to 6, with 0 to 1 indicating no disability, 2 to 5 indicating increasing disability, and 6 indicating death)
2 secondary outcomes
Neurological deficit amelioration
Time frame: 14 post-randomization days, 90days
Patient quality of life
Time frame: 14 post-randomization days, 90days
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 27 Dec 2021.
- Resource links provided by the National Library of MedicineLink provided by the sponsor.
- Resource links provided by the National Library of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diterpene ginkgolides meglumine injection and Ginaton in people with Stroke and Ischemic Stroke, run by Dongzhimen Hospital, Beijing 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 4 inclusion and 8 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 27 Dec 2021. 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. 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?
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?
Excellent functional outcome (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 27 Dec 2021.