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

Sponsor

Dongzhimen Hospital, Beijing (Other)

Overall Status

Completed

CT.gov ID

NCT05169450

Collaborator

(none)

998

Enrollment

Location

Arms

Actual Duration (Months)

110.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke Ischemic Stroke Nervous System Diseases Cerebral Infarction Brain Ischemia Brain Infarction	Drug: Diterpene ginkgolides meglumine injection Drug: Ginaton	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

998 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jul 1, 2013

Actual Primary Completion Date :

Apr 1, 2014

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Diterpene ginkgolides meglumine injection Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care. Other Names: Ginkgolides Diterpene Lactone Meglumine Injection
Active Comparator: 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.	Drug: Ginaton Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.

Arm

Intervention/Treatment

Experimental: 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.

Drug: Diterpene ginkgolides meglumine injection

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

Other Names:

Ginkgolides Diterpene Lactone Meglumine Injection

Active Comparator: 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.

Drug: Ginaton

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

Outcome Measures

Primary Outcome Measures

Excellent functional outcome [90 days]
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)

Secondary Outcome Measures

Neurological deficit amelioration [14 post-randomization days, 90days]
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
Patient quality of life [14 post-randomization days, 90days]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years and Older

Sexes Eligible for Study:

All

Accepts 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.