Efficacy and Safety of Mildronate for Acute Ischemic Stroke

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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01800357

Enrollment

240

Registered

2013-02-27

Start date

2013-01-31

Completion date

2014-08-31

Last updated

2013-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Ischemic Stroke

Keywords

randomized trial, acute ischemic stroke, mildronate

Brief summary

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

Detailed description

a randomized, double-blind, placebo-controlled phase II multicenter trial is conducted to evaluate the efficacy and safety of mildronate injection in patients with acute ischemic stroke. patients will be randomized to receive a 14-day treatment of placebo or mildronate (500mg/5ml/each).Primary end-point is the modified Rankin scale at 3 monthes. Secondary end-point is the NIHSS scores and the Barthel index at 8 days and 15days. The safety end-point is defined as the incidence of adverse events, the change of Samples for routine laboratory tests and vital signs. Analysis is by intention to treat.

Interventions

DRUGinfusion of mildronate

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

DRUGplacebo

infusion of plabcebo once a day and for 14 days

DRUGaspirin

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

\- 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

Design outcomes

Primary

Measure	Time frame
the modified Rankin scale	3 months

Secondary

Measure	Time frame
NIHSS scores	8 days
the Barthel index	8 days

Countries

China

Contacts

Primary ContactGang Zhao, MD

zhaogang@fmmu.edu.cn02984775361

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026