NCT01800357

Efficacy and Safety of Mildronate for Acute Ischemic Stroke

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

Detailed description

a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	infusion of mildronate	infusion of mildronate(500mg) once a day and for 14 days
DRUG	placebo	infusion of plabcebo once a day and for 14 days
DRUG	aspirin	infusion of aspirin (100mg) once a day for days

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2013-02-27
• Last updated: 2013-02-27

Locations

1 site across 1 country: China