Mildronate for Acute Ischemic Stroke

Air Force Military Medical University of People's Liberation Army

Status and phase: Completed; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: aspirin; Drug: cinepazide maleate injection; Drug: mildronate injection

Study type: Interventional

Funder types: Other

Identifiers

NCT01831011

xijing-008

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 227 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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227 participants in 2 patient groups

mildronate

Experimental group

Description:

infusion of mildronate

Treatment:

Drug: mildronate injection

Drug: aspirin

cinepazide maleate

Active Comparator group

Description:

infusion of cinepazide maleate

Treatment:

Drug: cinepazide maleate injection

Drug: aspirin