Efficacy and Safety of Mildronate for Acute Ischemic Stroke

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Unknown
Phase 2

Conditions

Acute Ischemic Stroke

Treatments

Drug: infusion of mildronate
Drug: aspirin
Drug: placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT01800357
xijing-007

Details and patient eligibility

About

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

Full 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.

Enrollment

240 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

240 participants in 2 patient groups, including a placebo group

mildronate
Experimental group
Description:
infusion of mildronate
Treatment:
Drug: aspirin
Drug: infusion of mildronate
placebo
Placebo Comparator group
Description:
infusion of placebo mildronate
Treatment:
Drug: placebo
Drug: aspirin

Trial contacts and locations

1

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Central trial contact

Gang Zhao, MD

Data sourced from clinicaltrials.gov

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