NCT00059332

Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial

Field Administration of Stroke Therapy-Magnesium Trial: A Randomized, Double-Blind, Placebo Controlled Trial of Neuroprotective Magnesium Sulfate Therapy for Acute Stroke Initiated Within 2 Hours of Onset by Paramedics in the Field

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,700 (actual)
• Sponsor: Jeffrey L. Saver · Academic / Other
• Sex: All
• Age: 40 Years – 95 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.

Detailed description

Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke. Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage. The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.

Conditions

• Cerebrovascular Accident

Interventions

Type	Name	Description
DRUG	Magnesium Sulfate	Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
DRUG	Normal Saline	Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.

Timeline

• Start date: 2005-01-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2003-04-24
• Last updated: 2015-08-21
• Results posted: 2015-08-21

Locations

1 site across 1 country: United States