Efficacy and Safety of Mildronate for Acute Ischemic Stroke

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-08-31

Brief Summary

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

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Detailed Description

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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

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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mildronate

infusion of mildronate

Group Type EXPERIMENTAL

infusion of mildronate

Intervention Type DRUG

infusion of mildronate(500mg) once a day and for 14 days

aspirin

Intervention Type DRUG

infusion of aspirin (100mg) once a day for days

placebo

infusion of placebo mildronate

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

infusion of plabcebo once a day and for 14 days

aspirin

Intervention Type DRUG

infusion of aspirin (100mg) once a day for days

Interventions

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infusion of mildronate

infusion of mildronate(500mg) once a day and for 14 days

Intervention Type DRUG

placebo

infusion of plabcebo once a day and for 14 days

Intervention Type DRUG

aspirin

infusion of aspirin (100mg) once a day for days

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No