Mildronate for Acute Ischemic Stroke

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Drug: mildronate injection
* Drug: cinepazide maleate injection
* Drug: aspirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (i) had a clinical diagnosis of acute ischaemic stroke ,on the first episode within the previous 7 days, and confirmed on CT or MRI brain imaging.(ii) were between 18 to 80 years of age (patients >= 70 years were not combined with any other poor physical condition except ischaemic stroke )(iii)had a score of 5-22 on the National Institutes of Health Stroke Scale (NIHSS).(iv)had a report that liver and kedney function were less than 1.5 folds of normal value. Exclusion Criteria: (i) had other intracranial pathologies (e.g. cerebral hemorrhage, tumour, infection), (ii) were pregnant or nursing ;(iii) had a neurological or psychiatric disease ;(iv) had significant drug or alcohol misuse, (v)had been given thrombolytic therapy or medication forbidden by study protocol; (vi)participated in a clinical trial in the past 3 months.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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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: mildronate injection<br> <br> * Other names: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da;Drug: aspirin<br> <br> * Other names: infusion of aspirin (100mg) once a day for days;|
| Active Comparator: cinepazide maleate<br>infusion of cinepazide maleate | Drug: cinepazide maleate injection<br> <br> * Other names: infusion of plabcebo once a day and for 14 days;Drug: aspirin<br> <br> * Other names: infusion of aspirin (100mg) once a day for days;|

What is the study measuring?
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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 |  | 15 days | 
| the Barthel index |  | 15 days | 

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