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Completed

NCT Number: NCT01831011

Mildronate for Acute Ischemic Stroke

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

the Department of Neurology

Xi’an, Shanxi, 710032, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

mildronate injection

Drug

Other names: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da

cinepazide maleate injection

Drug

Other names: infusion of plabcebo once a day and for 14 days

Aspirin

Drug

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

Primary outcomes

  1. the modified Rankin scale

    Time frame: 3 months

Secondary outcomes

  1. NIHSS scores

    Time frame: 15 days

  2. the Barthel index

    Time frame: 15 days

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 12, 2013
Registry last updated
Apr 12, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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