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

NCT ID: NCT05169450

Last Updated: 2021-12-27

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.

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

Keywords

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Diterpene Ginkgolides Meglumine Injection acute ischemic stroke effectiveness

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

Sponsors

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Dongzhimen Hospital, Beijing

OTHER

Sponsor Role lead

Responsible Party

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Ying Gao

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, , China

Site Status

Countries

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China

Related Links

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https://druginfo.nlm.nih.gov/drugportal/name/Meglumine

Resource links provided by the National Library of Medicine

https://druginfo.nlm.nih.gov/drugportal/name/Ginkgo+biloba

Resource links provided by the National Library of Medicine

Other Identifiers

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TJ2013012

Identifier Type: -

Identifier Source: org_study_id