NCT05169450

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 998 (actual)
• Sponsor: Dongzhimen Hospital, Beijing · Academic / Other
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Ischemic Stroke
• Nervous System Diseases
• Cerebral Infarction
• Brain Ischemia
• Brain Infarction

Interventions

Type	Name	Description
DRUG	Diterpene ginkgolides meglumine injection	Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
DRUG	Ginaton	Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-04-01
• Completion: 2014-04-01
• First posted: 2021-12-27
• Last updated: 2021-12-27

Locations

1 site across 1 country: China