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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169450
• Other study ID #: TJ2013012
• Status: Completed
• Phase: N/A
• Start date: July 1, 2013
• Est. completion date: April 1, 2014

Study information

• Verified date: December 2021
• Source: Dongzhimen Hospital, Beijing
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 998
• Est. completion date: April 1, 2014
• Est. primary completion date: April 1, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Diterpene ginkgolides meglumine injection
Patients will receive intravenously administered diterpene ginkgolides meglumine injection, combined with guidelines-based standard care.
• Ginaton
Patients will receive intravenously administered Ginaton, combined with guidelines-based standard care.

Locations

Country	Name	City	State
China	Dongzhimen Hospital, Beijing University of Chinese Medicine	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Dongzhimen Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

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