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

Dongzhimen Hospital, Beijing998 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

998

Conditions

Stroke Ischemic Stroke Nervous System Diseases

Interventions

Diterpene ginkgolides meglumine injectionDRUG

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.

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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)

Time frame: 90 days

Secondary Outcomes

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

Time frame: 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).