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

Dongzhimen Hospital, Beijing

Status: Completed

Conditions: Brain Ischemia; Cerebral Infarction; Ischemic Stroke; Stroke; Brain Infarction; Nervous System Diseases

Treatments: Drug: Ginaton; Drug: Diterpene ginkgolides meglumine injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05169450

TJ2013012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 998 patients

Sex: All

Ages: 35+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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998 participants in 2 patient groups

Diterpene ginkgolides meglumine injection

Experimental group

Description:

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.

Treatment:

Drug: Diterpene ginkgolides meglumine injection

Ginaton

Active Comparator group

Description:

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.

Treatment:

Drug: Ginaton