Efficacy and Safety of Mildronate for Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Interventions
- Registration Number
- NCT01800357
- Lead Sponsor
- Xijing Hospital
- Brief 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 240
- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5~22 on the first stage
- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description mildronate infusion of mildronate infusion of mildronate mildronate aspirin infusion of mildronate placebo placebo infusion of placebo mildronate placebo aspirin infusion of placebo mildronate
- Primary Outcome Measures
Name Time Method the modified Rankin scale 3 months
- Secondary Outcome Measures
Name Time Method NIHSS scores 15 days the Barthel index 15 days
Trial Locations
- Locations (1)
the Department of Neurology , Xijing Hospital
🇨🇳Xi'an, Shaanxi, China