NCT01831011

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
227

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

April 10, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2013

Completed
Last Updated

April 12, 2013

Status Verified

April 1, 2013

Enrollment Period

1.8 years

First QC Date

April 10, 2013

Last Update Submit

April 10, 2013

Conditions

Acute Ischemic Stroke

Keywords

randomized trialacute ischemic strokemildronate

Outcome Measures

Primary Outcomes (1)

  • the modified Rankin scale

    3 months

Secondary Outcomes (2)

  • NIHSS scores

    15 days

  • the Barthel index

    15 days

Study Arms (2)

mildronate

EXPERIMENTAL

infusion of mildronate

Drug: mildronate injectionDrug: aspirin

cinepazide maleate

ACTIVE COMPARATOR

infusion of cinepazide maleate

Drug: cinepazide maleate injectionDrug: aspirin

Interventions

mildronate injectionDRUG
Also known as: infusion of mildronate infusion of mildronate(500mg) once a day and for 14 da
mildronate
cinepazide maleate injectionDRUG
Also known as: infusion of plabcebo once a day and for 14 days
cinepazide maleate
aspirinDRUG
Also known as: infusion of aspirin (100mg) once a day for days
cinepazide maleatemildronate

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • (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.

You may not qualify if:

  • (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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Department of Neurology

Xi’an, Shanxi, 710032, China

Location

MeSH Terms

Conditions

Ischemic Stroke

Interventions

3-(2,2,2-trimethylhydrazine)propionatecinepazideWW Domain-Containing OxidoreductaseAspirin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Short Chain Dehydrogenase-ReductasesNAD (+) and NADP (+) Dependent Alcohol OxidoreductasesAlcohol OxidoreductasesOxidoreductasesEnzymesEnzymes and CoenzymesTumor Suppressor ProteinsNeoplasm ProteinsProteinsAmino Acids, Peptides, and ProteinsSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gang Zhao, MD

    the Department of Neurology , Xijing Hospital

    STUDY DIRECTOR

  • Guang Yun Zhang, MD

    the Department of Neurology , Xijing Hospital

    PRINCIPAL INVESTIGATOR

  • Yi Zhu, MD

    the Department of Neurology , Xijing Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2013

First Posted

April 12, 2013

Study Start

July 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

April 12, 2013

Record last verified: 2013-04

Locations

CN(1)