Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 998
- 试验地点
- 1
- 主要终点
- Excellent functional outcome
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Diterpene ginkgolides meglumine injection
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.
干预措施: Diterpene ginkgolides meglumine injection (Drug)
Ginaton
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.
干预措施: Ginaton (Drug)
结局指标
主要结局
Excellent functional outcome
时间窗: 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)
次要结局
- Patient quality of life(14 post-randomization days, 90days)
- Neurological deficit amelioration(14 post-randomization days, 90days)
研究者
Ying Gao
Professor
Dongzhimen Hospital, Beijing