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

Tracking Information

First Received Date ^ICMJE

April 23, 2003

Last Updated Date

May 19, 2009

Start Date ^ICMJE

January 2005

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

The primary endpoint is the modified Rankin Scale global measure of functional outcome, assessed 90 days after treatment.

Change History

Complete list of historical versions of study NCT00059332 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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, 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Condition ^ICMJE

Cerebrovascular Accident

Intervention ^ICMJE

Drug: magnesium sulfate
Drug: placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1298

Estimated Completion Date

June 2011

Estimated Primary Completion Date

June 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 95 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jeffrey Saver, M.D.

310-794-6379

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00059332

Responsible Party

Jeffrey Saver, MD, Professor of Neurology and Director of the UCLA Stroke Center, Geffen School of Medicine at UCLA

Study ID Numbers ^ICMJE

R01NS44364

Study Sponsor ^ICMJE

University of California, Los Angeles

Collaborators ^ICMJE

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators ^ICMJE

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

Information Provided By

University of California, Los Angeles

Verification Date

February 2009

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