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

• Status: Completed
• Trial end date: 2014-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongzhimen Hospital, Beijing

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.