Dongzhimen Hospital, Beijing University of Chinese Medicine
Beijing, 100700, China
NCT Number: NCT05169450
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.
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Notify Me35 year and older
All sexes
Interventional
Not applicable
Beijing, 100700, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
Other names: Ginkgolides Diterpene Lactone Meglumine Injection
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.
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)
Time frame: 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
Time frame: 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).
Dongzhimen Hospital, Beijing
Other
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
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