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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by University of California, Los Angeles.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00059332
First received: April 23, 2003
Last updated: December 12, 2011
Last verified: December 2011

April 23, 2003
December 12, 2011
January 2005
June 2013   (final data collection date for primary outcome measure)
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 ]
Not Provided
Complete list of historical versions of study NCT00059332 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Cerebrovascular Accident
  • 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.
  • Experimental: Magnesium Sulfate
    Intervention: Drug: Magnesium Sulfate
  • Placebo Comparator: Normal saline
    Intervention: Drug: Normal Saline
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1700
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
  • Age 40-95, inclusive
  • Last known well time within 2 hours of treatment initiation
  • Deficit present for >/= 15 minutes

Exclusion Criteria:

  • Coma
  • Rapidly improving neurologic deficit
  • Pre-existing neurologic, psychiatric, or advanced systemic disease that would confound the neurological or functional outcome evaluations
  • SBP < 90 or > 220
  • Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
  • Severe respiratory distress (O2 sat < 90% or respiratory rate < 12 or >/= 24)
  • Known second or third degree heart block with no pacemaker in place
  • Major head trauma in the last 24 hours
  • Recent stroke within prior 30 days
  • Patient unable to give informed consent and no available on scene consent or assent provider
Both
40 Years to 95 Years
No
Contact: Jeffrey Saver, M.D. 310-794-6379
United States
 
NCT00059332
U01NS44364, U01NS044364
Yes
Jeffrey L. Saver, University of California, Los Angeles
Jeffrey L. Saver
National Institute of Neurological Disorders and Stroke (NINDS)
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
University of California, Los Angeles
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP