Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Recruitment status was Recruiting
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.
Drug: Magnesium Sulfate
Drug: Normal Saline
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||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|
- The primary endpoint is the modified Rankin Scale global measure of global disability, assessed 90 days after treatment. [ Time Frame: 3 months after stroke onset ] [ Designated as safety issue: No ]
- Barthel Index measure of activities of daily living [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- NIH Stroke Scale measure of neurologic deficit [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Stroke Impact Scale measure of stroke-specific quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
- Symptomatic hemorrhagic transformation [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
- Recurrent ischemic stroke [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2005|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
|Experimental: Magnesium Sulfate||
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.
|Placebo Comparator: Normal saline||
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.
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, 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00059332
|Contact: Jeffrey Saver, M.D.||310-794-6379|
|United States, California|
|The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Jeffrey Saver, M.D. 310-794-6379|
|Principal Investigator: Jeffrey Saver, M.D.|
|Principal Investigator:||Jeffrey Saver, M.D.||UCLA School of Medicine, Study Overall Principal Investigator|
|Principal Investigator:||Sidney Starkman, M.D.||UCLA Stroke Center, Co-Principal Investigator|
|Principal Investigator:||Marc Eckstein, M.D.||Los Angeles City Emergency Medical Service, Co-Principal Investigator|
|Principal Investigator:||Samuel Stratton, MD||Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator|
|Principal Investigator:||Frank Pratt, MD||Los Angeles County Emergency Medical Service, Co-Principal Investigator|