Efficacy and Safety of Mildronate for Acute Ischemic Stroke

Study Overview
=================
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.

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

Conditions
-----------------
Acute Ischemic Stroke

Intervention / Treatment
-----------------
* Drug: infusion of mildronate
* Drug: placebo
* Drug: aspirin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5 22 on the first stage Exclusion Criteria: - 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: mildronate<br>infusion of mildronate | Drug: infusion of mildronate<br>* infusion of mildronate(500mg) once a day and for 14 days<br>Drug: aspirin<br>* infusion of aspirin (100mg) once a day for days<br>|
| Placebo Comparator: placebo<br>infusion of placebo mildronate | Drug: placebo<br>* infusion of plabcebo once a day and for 14 days<br>Drug: aspirin<br>* infusion of aspirin (100mg) once a day for days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the modified Rankin scale |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSS scores |  | 8 days | 
| NIHSS scores |  | 15 days | 
| the Barthel index |  | 8 days | 
| the Barthel index |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized trial, acute ischemic stroke, mildronate