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

Sponsor:	University of California, Los Angeles
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00059332

Purpose

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.

Condition	Intervention	Phase
Cerebrovascular Accident	Drug: magnesium sulfate Drug: placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
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

Resource links provided by NLM:

MedlinePlus related topics: Emergency Medical Services

Drug Information available for: Magnesium sulfate Magnesium

U.S. FDA Resources

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	1298
Study Start Date:	January 2005
Estimated Study Completion Date:	June 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: magnesium sulfate Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes or matched placebo, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours or matched placebo.
B: Placebo Comparator	Drug: placebo an inactive substance

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, 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.

Eligibility

Ages Eligible for Study:	40 Years to 95 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059332

Contacts

Contact: Jeffrey Saver, M.D.

310-794-6379

Locations

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.

Sponsors and Collaborators

University of California, Los Angeles

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:	Jeffrey Saver, M.D.	University of California, Los Angeles
Investigator:	Sidney Starkman, M.D.	UCLA Stroke Center, co-Principal Investigator
Investigator:	Marc Eckstein, M.D.	Los Angeles City Emergency Medical Service, co-Principal Investigator
Investigator:	Samuel Stratton, MD	Los Angeles Emergency Medical Services Agency, co-Principal Investigator
Investigator:	Frank Pratt, MD	Los Angeles County Emergency Medical Service, Investigator

More Information

Additional Information:

The official FAST-MAG Clinical Trial website This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Geffen School of Medicine at UCLA ( Jeffrey Saver, MD, Professor of Neurology and Director of the UCLA Stroke Center )
Study ID Numbers:	R01NS44364
Study First Received:	April 23, 2003
Last Updated:	May 19, 2009
ClinicalTrials.gov Identifier:	NCT00059332 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:

stroke
brain attack
magnesium sulfate

neuroprotection
prehospital care
emergency medical services

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Cerebral Infarction
Magnesium Sulfate
Physiological Effects of Drugs
Anesthetics
Calcium Channel Blockers
Reproductive Control Agents
Brain Diseases
Cerebrovascular Disorders
Membrane Transport Modulators
Tocolytic Agents
Sensory System Agents
Therapeutic Uses
Brain Ischemia

Cardiovascular Diseases
Analgesics
Anti-Arrhythmia Agents
Nervous System Diseases
Stroke
Vascular Diseases
Central Nervous System Diseases
Central Nervous System Depressants
Cardiovascular Agents
Pharmacologic Actions
Brain Infarction
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on November 30, 2009