NCT01800357

Brief Summary

This study seeks to evaluate the efficacy and safety of mildronate injection in treating acute ischemic stroke

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

February 27, 2013

Status Verified

January 1, 2013

Enrollment Period

1.4 years

First QC Date

February 25, 2013

Last Update Submit

February 25, 2013

Conditions

Acute Ischemic Stroke

Keywords

randomized trialacute ischemic strokemildronate

Outcome Measures

Primary Outcomes (1)

  • the modified Rankin scale

    3 months

Secondary Outcomes (4)

  • NIHSS scores

    8 days

  • NIHSS scores

    15 days

  • the Barthel index

    8 days

  • the Barthel index

    15 days

Study Arms (2)

mildronate

EXPERIMENTAL

infusion of mildronate

Drug: infusion of mildronateDrug: aspirin

placebo

PLACEBO COMPARATOR

infusion of placebo mildronate

Drug: placeboDrug: aspirin

Interventions

infusion of mildronateDRUG

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

mildronate
placeboDRUG

infusion of plabcebo once a day and for 14 days

placebo
aspirinDRUG

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

mildronateplacebo

Eligibility Criteria

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

You may qualify if:

  • \- have a clinical diagnosis of acute ischemic stroke have CT or MRI brain imaging NIHSS scores:5\~22 on the first stage

You may not qualify if:

  • \- have other intracranial pathologies are pregnant or nursing have significant drug or alcohol misuse have been in a clinical trial in the past 3 months are unlikely to be available for follow-up have been given thrombolytic therapy or medication forbidden by study protocol have a neurological or psychiatric disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Department of Neurology , Xijing Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Aspirin

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Gang Zhao, MD

    the Department of Neurology , Xijing Hospital

    STUDY DIRECTOR

  • Yi Zhu, MD

    the Department of Neurology , Xijing Hospital

    STUDY CHAIR

Central Study Contacts

Gang Zhao, MD

CONTACT

02984775361zhaogang@fmmu.edu.cn

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

February 25, 2013

First Posted

February 27, 2013

Study Start

January 1, 2013

Primary Completion

June 1, 2014

Study Completion

August 1, 2014

Last Updated

February 27, 2013

Record last verified: 2013-01

Locations

CN(1)