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

Primary Purpose

Stroke, Ischemic Stroke, Nervous System Diseases

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Diterpene ginkgolides meglumine injection
Ginaton
Sponsored by
Dongzhimen Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Dongzhimen Hospital, Beijing University of Chinese Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Diterpene ginkgolides meglumine injection

Ginaton

Arm 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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
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).

Full Information

First Posted
December 6, 2021
Last Updated
December 23, 2021
Sponsor
Dongzhimen Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT05169450
Brief Title
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke
Official Title
Efficacy of Diterpene Ginkgolides Meglumine Injection in Elderly Patients With Ischemic Stroke: A Post Hoc Analysis of a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2013 (Actual)
Primary Completion Date
April 1, 2014 (Actual)
Study Completion Date
April 1, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dongzhimen Hospital, Beijing

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic Stroke, Nervous System Diseases, Cerebral Infarction, Brain Ischemia, Brain Infarction
Keywords
Diterpene Ginkgolides Meglumine Injection, acute ischemic stroke, effectiveness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
998 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diterpene ginkgolides meglumine injection
Arm Type
Experimental
Arm 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.
Arm Title
Ginaton
Arm Type
Active Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Diterpene ginkgolides meglumine injection
Other Intervention Name(s)
Ginkgolides Diterpene Lactone Meglumine Injection
Intervention Description
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
Intervention Type
Drug
Intervention Name(s)
Ginaton
Intervention Description
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.
Primary Outcome Measure Information:
Title
Excellent functional outcome
Description
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)
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Neurological deficit amelioration
Description
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
Time Frame
14 post-randomization days, 90days
Title
Patient quality of life
Description
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).
Time Frame
14 post-randomization days, 90days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Dongzhimen Hospital, Beijing University of Chinese Medicine
City
Beijing
ZIP/Postal Code
100700
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://druginfo.nlm.nih.gov/drugportal/name/Meglumine
Description
Resource links provided by the National Library of Medicine
URL
https://druginfo.nlm.nih.gov/drugportal/name/Ginkgo+biloba
Description
Resource links provided by the National Library of Medicine

Learn more about this trial

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

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