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Mildronate for Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status

Completed

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

mildronate injection

cinepazide maleate injection

aspirin

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke focused on measuring randomized trial, acute ischemic stroke, mildronate

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

the Department of Neurology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mildronate

cinepazide maleate

Arm Description

infusion of mildronate

infusion of cinepazide maleate

Outcomes

Primary Outcome Measures

the modified Rankin scale

Secondary Outcome Measures

NIHSS scores

the Barthel index

Full Information

NCT ID

NCT01831011

First Posted

April 10, 2013

Last Updated

April 10, 2013

Sponsor

Xijing Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01831011

Brief Title

Mildronate for Acute Ischemic Stroke

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

July 2008 (undefined)

Primary Completion Date

April 2010 (Actual)

Study Completion Date

April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Xijing Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Ischemic Stroke

Keywords

randomized trial, acute ischemic stroke, mildronate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

227 (Actual)

8. Arms, Groups, and Interventions

Arm Title

mildronate

Arm Type

Experimental

Arm Description

infusion of mildronate

Arm Title

cinepazide maleate

Arm Type

Active Comparator

Arm Description

infusion of cinepazide maleate

Intervention Type

Drug

Intervention Name(s)

mildronate injection

Other Intervention Name(s)

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

Intervention Type

Drug

Intervention Name(s)

cinepazide maleate injection

Other Intervention Name(s)

infusion of plabcebo once a day and for 14 days

Intervention Type

Drug

Intervention Name(s)

aspirin

Other Intervention Name(s)

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

Primary Outcome Measure Information:

Title

the modified Rankin scale

Time Frame

3 months

Secondary Outcome Measure Information:

Title

NIHSS scores

Time Frame

15 days

Title

the Barthel index

Time Frame

15 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gang Zhao, MD

Organizational Affiliation

the Department of Neurology , Xijing Hospital

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Guang Yun Zhang, MD

Organizational Affiliation

the Department of Neurology , Xijing Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yi Zhu, MD

Organizational Affiliation

the Department of Neurology , Xijing Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

the Department of Neurology

City

Xi an

State/Province

Shanxi

ZIP/Postal Code

710032

Country

China

12. IPD Sharing Statement

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Mildronate for Acute Ischemic Stroke

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