Mildronate for Acute Ischemic Stroke

Sponsor

Xijing Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01831011

Collaborator

(none)

227

Enrollment

Location

Arms

Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Ischemic Stroke	Drug: mildronate injection Drug: cinepazide maleate injection Drug: aspirin	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

227 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

Apr 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: mildronate infusion of mildronate	Drug: mildronate injection Other Names: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da Drug: aspirin Other Names: infusion of aspirin (100mg) once a day for days
Active Comparator: cinepazide maleate infusion of cinepazide maleate	Drug: cinepazide maleate injection Other Names: infusion of plabcebo once a day and for 14 days Drug: aspirin Other Names: infusion of aspirin (100mg) once a day for days

Arm

Intervention/Treatment

Experimental: mildronate

infusion of mildronate

Drug: mildronate injection

Other Names:

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

Drug: aspirin

Other Names:

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

Active Comparator: cinepazide maleate

infusion of cinepazide maleate

Drug: cinepazide maleate injection

Other Names:

infusion of plabcebo once a day and for 14 days

Drug: aspirin

Other Names:

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

Outcome Measures

Primary Outcome Measures

the modified Rankin scale [3 months]

Secondary Outcome Measures

NIHSS scores [15 days]
the Barthel index [15 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	the Department of Neurology	Xi an	Shanxi	China	710032

Sponsors and Collaborators

Xijing Hospital

Investigators

Study Director: Gang Zhao, MD, the Department of Neurology , Xijing Hospital
Principal Investigator: Guang Yun Zhang, MD, the Department of Neurology , Xijing Hospital
Principal Investigator: Yi Zhu, MD, the Department of Neurology , Xijing Hospital