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

Not Applicable

Completed

• Conditions: Cerebral Infarction; Brain Ischemia; Brain Infarction; Stroke; Nervous System Diseases; Ischemic Stroke
• Interventions: Drug: Ginaton; Drug: Diterpene ginkgolides meglumine injection

• Registration Number: NCT05169450
• Lead Sponsor: Dongzhimen Hospital, Beijing

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.

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 Timeline

• Study Start: 2013-07-01
• Primary Completion: 2014-04-01
• Study Completion: 2014-04-01
• Status Verified: 2021-12
• Study First Submitted: 2021-12-06
• Study First Submitted QC: 2021-12-23
• Last Update Submitted: 2021-12-23
• Study First Posted: 2021-12-27
• Last Update Posted: 2021-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 998

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ginaton	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.
Diterpene ginkgolides meglumine injection	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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).
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

Trial Locations

Locations (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine; 🇨🇳 Beijing, China