Stroke, Ischemic Stroke, Nervous System Diseases, Cerebral Infarction, Brain Ischemia, Brain Infarction
Conditions
Keywords
Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness
Brief 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. 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.
Interventions
DRUGDiterpene ginkgolides meglumine injection
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
DRUGGinaton
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.
Sponsors
Dongzhimen Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excellent functional outcome | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurological deficit amelioration | 14 post-randomization days, 90days | 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 |
| Patient quality of life | 14 post-randomization days, 90days | 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). |
Countries
China
Outcome results
None listed