Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke

Study Overview
=================
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.

Official Title
-----------------
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial

Conditions
-----------------
Cerebral Infarction, Stroke, Ischemic Stroke, Nervous System Diseases, Brain Ischemia, Brain Infarction

Intervention / Treatment
-----------------
* Drug: Diterpene ginkgolides meglumine injection
* Drug: Ginaton


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diterpene ginkgolides meglumine injection<br>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. | Drug: Diterpene ginkgolides meglumine injection<br>* Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.<br>* Other names: Ginkgolides Diterpene Lactone Meglumine Injection;|
| Active Comparator: Ginaton<br>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. | Drug: Ginaton<br>* Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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). | 14 post-randomization days, 90days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness