NCT05169450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
998

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
7.7 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

9 months

First QC Date

December 6, 2021

Last Update Submit

December 23, 2021

Conditions

StrokeIschemic StrokeNervous System DiseasesCerebral InfarctionBrain IschemiaBrain Infarction

Keywords

Diterpene Ginkgolides Meglumine Injectionacute ischemic strokeeffectiveness

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Neurological deficit amelioration

    14 post-randomization days, 90days

  • Patient quality of life

    14 post-randomization days, 90days

Study Arms (2)

Diterpene ginkgolides meglumine injection

EXPERIMENTAL

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

Ginaton

ACTIVE COMPARATOR

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

Interventions

Diterpene ginkgolides meglumine injectionDRUG

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

Also known as: Ginkgolides Diterpene Lactone Meglumine Injection
Diterpene ginkgolides meglumine injection
GinatonDRUG

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

Ginaton

Eligibility Criteria

Age35 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, 100700, China

Location

Related Links

MeSH Terms

Conditions

StrokeIschemic StrokeNervous System DiseasesCerebral InfarctionBrain IschemiaBrain Infarction

Interventions

ginaton

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 6, 2021

First Posted

December 27, 2021

Study Start

July 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)