Efficacy and Safety of Mildronate for Acute Ischemic Stroke

Air Force Military Medical University of People's Liberation Army

Status and phase: Unknown; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Drug: placebo; Drug: infusion of mildronate; Drug: aspirin

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

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240 participants in 2 patient groups, including a placebo group

mildronate

Experimental group

Description:

infusion of mildronate

Treatment:

Drug: infusion of mildronate

Drug: aspirin

placebo

Placebo Comparator group

Description:

infusion of placebo mildronate

Treatment:

Drug: aspirin

Drug: placebo