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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

998 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-01

Study Completion Date

2014-04-01

Brief Summary

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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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Detailed Description

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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.

Conditions

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Stroke Ischemic Stroke Nervous System Diseases Cerebral Infarction Brain Ischemia Brain Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Diterpene ginkgolides meglumine injection

Intervention Type DRUG

Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.

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.

Group Type ACTIVE_COMPARATOR

Ginaton

Intervention Type DRUG

Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.

Interventions

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Diterpene ginkgolides meglumine injection

Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.

Intervention Type DRUG

Ginaton

Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.

Intervention Type DRUG

Other Intervention Names

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Ginkgolides Diterpene Lactone Meglumine Injection

Eligibility Criteria

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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.

Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No