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

Sponsor:	Jeffrey L. Saver
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):	Jeffrey L. Saver, 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: Normal Saline	Phase III

Study Type:	Interventional
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

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:	1700
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)

Arms	Assigned Interventions
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.

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

Jeffrey L. Saver

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

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

More Information

Additional Information:

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

No publications provided

Responsible Party:	Jeffrey L. Saver, Professor of Neurology, University of California, Los Angeles
ClinicalTrials.gov Identifier:	NCT00059332 History of Changes
Other Study ID Numbers:	U01NS44364, U01NS044364
Study First Received:	April 23, 2003
Last Updated:	December 12, 2011
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:

Cerebral Infarction
Stroke
Brain Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Magnesium Sulfate
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics
Central Nervous System Depressants
Anti-Arrhythmia Agents
Cardiovascular Agents
Anticonvulsants
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Tocolytic Agents
Reproductive Control Agents

ClinicalTrials.gov processed this record on February 12, 2012