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Completed

NCT Number: NCT05169450

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

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.

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Key information

Age range

35 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongzhimen Hospital, Beijing University of Chinese Medicine

Beijing, 100700, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Diterpene ginkgolides meglumine injection

Drug

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

Other names: Ginkgolides Diterpene Lactone Meglumine Injection

Ginaton

Drug

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

Primary outcomes

  1. Excellent functional outcome

    Time frame: 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 outcomes

  1. Neurological deficit amelioration

    Time frame: 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

  2. Patient quality of life

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Dongzhimen Hospital, Beijing

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 27, 2021
Registry last updated
Dec 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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