NCT01831011

Mildronate for Acute Ischemic Stroke

Efficacy and Safety of Mildronate for Acute Ischemic Stroke: a Randomized, Double-blind, Active-controlled Phase II Multicenter Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Mildronate an inhibitor of carnitine-dependent metabolism, is considered an anti-ischemic drug. This study aims to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke.

Detailed description

A randomized, double-blind, multi-center clinical study was made on mildronate injection for treating acute cerebral infarction. 113 cases in the experimental group were given with mildronate injection, while 114 cases in the active-control group were given with cinepazide maleate injection. In addition, both groups were given aspirin as basic treatments. Modified Rankin Scale (mRS) score at 2 weeks and 3 months, National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index score at 2 weeks after treatment, vital signs and adverse events were evaluated.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	mildronate injection
DRUG	cinepazide maleate injection
DRUG	aspirin

Timeline

• Start date: 2008-07-01
• Primary completion: 2010-04-01
• Completion: 2010-04-01
• First posted: 2013-04-12
• Last updated: 2013-04-12

Locations

1 site across 1 country: China