Mildronate for Acute Ischemic Stroke

Phase 2

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: mildronate injection; Drug: cinepazide maleate injection; Drug: aspirin

• Registration Number: NCT01831011
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2008-07
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2013-04
• Study First Submitted: 2013-04-10
• Study First Submitted QC: 2013-04-10
• Last Update Submitted: 2013-04-10
• Study First Posted: 2013-04-12
• Last Update Posted: 2013-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 227

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
mildronate	mildronate injection	infusion of mildronate
mildronate	aspirin	infusion of mildronate
cinepazide maleate	cinepazide maleate injection	infusion of cinepazide maleate
cinepazide maleate	aspirin	infusion of cinepazide maleate

Primary Outcome Measures

Name	Time	Method
the modified Rankin scale	3 months

Secondary Outcome Measures

Name	Time	Method
NIHSS scores	15 days
the Barthel index	15 days

Trial Locations

Locations (1)

the Department of Neurology; 🇨🇳 Xi an, Shanxi, China