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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Nervous System Diseases; Ischemic Stroke; Brain Ischemia; Cerebral Infarction; Brain Infarction
• Intervention / Treatment: Drug: Diterpene ginkgolides meglumine injection; Drug: Ginaton

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 Type: Interventional
• Enrollment (Actual): 998
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100700
    • Dongzhimen Hospital, Beijing University of Chinese Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excellent functional outcome	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)	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological deficit amelioration	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	14 post-randomization days, 90days
Patient quality of life	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).	14 post-randomization days, 90days

Collaborators and Investigators

• Sponsor: Dongzhimen Hospital, Beijing

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: December 6, 2021
• First Submitted That Met QC Criteria: December 23, 2021
• First Posted (Actual): December 27, 2021

Study Record Updates

• Last Update Posted (Actual): December 27, 2021
• Last Update Submitted That Met QC Criteria: December 23, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: effectiveness; acute ischemic stroke; Diterpene Ginkgolides Meglumine Injection
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Infarction; Stroke; Ischemic Stroke; Brain Ischemia; Ischemia; Nervous System Diseases; Cerebral Infarction; Brain Infarction
• Other Study ID Numbers: TJ2013012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No