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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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00059332
Acronym
FAST-MAG
Enrollment
1700
Registered
2003-04-24
Start date
2005-01-31
Completion date
2013-03-31
Last updated
2015-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebrovascular Accident

Keywords

stroke, brain attack, magnesium sulfate, neuroprotection, prehospital care, emergency medical services

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, tissue plasminogen activator (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.

Interventions

DRUGMagnesium 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.

DRUGNormal 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.

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Jeffrey L. Saver
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 95 Years
Healthy volunteers
No

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 * Systolic Blood Pressure (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

Design outcomes

Primary

MeasureTime frameDescription
Modified Rankin Scale3 months after stroke onsetModified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Secondary

MeasureTime frameDescription
Modified Rankin Score ≤23 monthsFunctional independence based on modified Rankin score
NIH Stroke Scale3 monthsThe National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention
Barthel Index3 monthsThe Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)
Modified Rankin Score of 0 or 13 monthsMinimal or no disability based on the modified Rankin score
Serious Adverse Events3 months—
Symptomatic Intracranial Hemorrhage3 month—
Mortality3 months—
Stroke Impact Scale3 monthsThe Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes. 1. Physical problems 2. Memory and thinking 3. Mood and emotions 4. Communication, reading and understanding 5. Daily activities 6. Mobility at home and in the community 7. Affected hand use 8. Hobbies and activities participation

Countries

United States

Participant flow

Participants by arm

ArmCount
Normal Saline
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.
843
Magnesium Sulfate
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.
857
Total1,700

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up11
Overall StudyWithdrawal by Subject21

Baseline characteristics

CharacteristicNormal SalineMagnesium SulfateTotal
Age, Continuous69 years
STANDARD_DEVIATION 13.6
69 years
STANDARD_DEVIATION 13.4
69 years
STANDARD_DEVIATION 13.5
Age, Customized
60-75 years of age
284 participants278 participants562 participants
Age, Customized
<60 years of age
239 participants242 participants481 participants
Age, Customized
>75 years of age
320 participants337 participants657 participants
Ethnicity (NIH/OMB)
Hispanic or Latino
206 Participants196 Participants402 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
637 Participants661 Participants1298 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Final Diagnosis
Cerebral Ischemia
613 participants632 participants1245 participants
Final Diagnosis
Cerebrovascular-mimicking condition
37 participants30 participants67 participants
Final Diagnosis
Intracranial Hemorrhage
192 participants195 participants387 participants
Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia205 participants242 participants447 participants
Los Angeles Motor Scale at hospital arrival3.3 units on a scale
STANDARD_DEVIATION 2.2
3.4 units on a scale
STANDARD_DEVIATION 2.3
3.4 units on a scale
STANDARD_DEVIATION 2.3
Medical History
Alcohol use
328 participants326 participants654 participants
Medical History
Atrial fibrillation
175 participants194 participants369 participants
Medical History
Diabetes
188 participants189 participants377 participants
Medical History
Hyperlipidimia
407 participants398 participants805 participants
Medical History
Hypertension
648 participants671 participants1319 participants
Medical History
Myocardial infarction
82 participants94 participants176 participants
Medical History
Tobacco use
158 participants139 participants297 participants
National Institute of Health Stroke Scale (NIHSS) at hospital arrival11.2 units on a scale
STANDARD_DEVIATION 9.8
11.5 units on a scale
STANDARD_DEVIATION 9.9
11.3 units on a scale
STANDARD_DEVIATION 9.9
Prestroke function - Living at home823 participants834 participants1657 participants
Race (NIH/OMB)
American Indian or Alaska Native
5 Participants4 Participants9 Participants
Race (NIH/OMB)
Asian
62 Participants77 Participants139 Participants
Race (NIH/OMB)
Black or African American
113 Participants106 Participants219 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants6 Participants8 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
661 Participants664 Participants1325 Participants
Sex: Female, Male
Female
367 Participants358 Participants725 Participants
Sex: Female, Male
Male
476 Participants499 Participants975 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
331 / 843329 / 857
serious
Total, serious adverse events
422 / 843439 / 857

Outcome results

Primary

Modified Rankin Scale

Modified Rankin Scales (mRS) is a measure of global disability. Total Scale range is 0-6, with lower values indicating better outcomes. 0 No symptoms at all 1. No significant disability despite symptoms; able to carry out all usual duties and activities 2. Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance 3. Moderate disability; requiring some help, but able to walk without assistance 4. Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance 5. Severe disability; bedridden, incontinent and requiring constant nursing care and attention 6. Dead

Time frame: 3 months after stroke onset

ArmMeasureValue (MEDIAN)
Normal SalineModified Rankin Scale2 units on a scale
Magnesium SulfateModified Rankin Scale2 units on a scale
Comparison: For the primary efficacy analysis, data were analyzed to test the null hypothesis that the distribution of scores over all 7 levels of the modified Rankin Scale at Day 90 was identical in the magnesium sulfate and placebo groups, vs. the one-sided alternative that the distribution of scores is shifted lower in the active magnesium sulfate therapy group. The statistic used to test the primary hypothesis was the Cochran-Mantel-Haenszel test statistic stratified by transport vehicle.p-value: 0.28Cochran-Mantel-Haenszel
Secondary

Barthel Index

The Barthel Index is a measure of activities of daily living. Total score is calculated by addition of subscale scores. Total score range is 0-100, with higher scores indicating better outcomes. The ten subitems are: FEEDING (Subscale range is 0-10) BATHING (Subscale range is 0-5) GROOMING (Subscale range is 0-5) DRESSING (Subscale range is 0-10) BOWELS (Subscale range is 0-10) BLADDER (Subscale range is 0-10) TOILET USE (Subscale range is 0-10) TRANSFERS (Subscale range is 0-15) MOBILITY (Subscale range is 0-15) STAIRS (Subscale range is 0-10)

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Normal SalineBarthel Index95 units on a scale
Magnesium SulfateBarthel Index90 units on a scale
p-value: 0.3912Wilcoxon (Mann-Whitney)
Secondary

Modified Rankin Score ≤2

Functional independence based on modified Rankin score

Time frame: 3 months

ArmMeasureValue (NUMBER)
Normal SalineModified Rankin Score ≤2445 participants
Magnesium SulfateModified Rankin Score ≤2449 participants
p-value: 0.8795% CI: [0.81, 1.19]Chi-squared
Secondary

Modified Rankin Score of 0 or 1

Minimal or no disability based on the modified Rankin score

Time frame: 3 months

ArmMeasureValue (NUMBER)
Normal SalineModified Rankin Score of 0 or 1311 participants
Magnesium SulfateModified Rankin Score of 0 or 1313 participants
p-value: 0.8795% CI: [0.81, 1.2]Chi-squared
Secondary

Mortality

Time frame: 3 months

ArmMeasureValue (NUMBER)
Normal SalineMortality131 participants
Magnesium SulfateMortality132 participants
p-value: 0.9595% CI: [0.76, 1.29]Chi-squared
Secondary

NIH Stroke Scale

The National Institute of Health Stroke Scale (NIHSS) is a measure of neurologic deficit. Total Score range 0-42, with higher scores indicating greater severity. The 11 domains assessed are: 1a-c Level of consciousness 2. Best Gaze 3. Visual 4. Facial Palsy 5a. Motor left arm 5b. Motor right arm 6a. Motor left leg 6b. Motor right leg 7. Limb Ataxia 8. Sensory 9. Best Language 10. Dysarthria 11. Extinction and Inattention

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Normal SalineNIH Stroke Scale3 units on a scale
Magnesium SulfateNIH Stroke Scale3 units on a scale
p-value: 0.276Wilcoxon (Mann-Whitney)
Secondary

Serious Adverse Events

Time frame: 3 months

ArmMeasureValue (NUMBER)
Normal SalineSerious Adverse Events422 participants
Magnesium SulfateSerious Adverse Events439 participants
p-value: 0.9595% CI: [0.87, 1.27]Chi-squared
Secondary

Stroke Impact Scale

The Stroke Impact Scale (SIS) is a measure of stroke-specific quality of life. The scale assesses 8 domains. Scores for each domain range from 0-100, with higher scores indicating better outcomes. 1. Physical problems 2. Memory and thinking 3. Mood and emotions 4. Communication, reading and understanding 5. Daily activities 6. Mobility at home and in the community 7. Affected hand use 8. Hobbies and activities participation

Time frame: 3 months

ArmMeasureValue (MEDIAN)
Normal SalineStroke Impact Scale65 units on a scale
Magnesium SulfateStroke Impact Scale67 units on a scale
p-value: 0.323Wilcoxon (Mann-Whitney)
Secondary

Symptomatic Intracranial Hemorrhage

Time frame: 3 month

ArmMeasureValue (NUMBER)
Normal SalineSymptomatic Intracranial Hemorrhage28 participants
Magnesium SulfateSymptomatic Intracranial Hemorrhage18 participants
p-value: 0.1295% CI: [0.34, 1.14]Chi-squared

Source: ClinicalTrials.gov · Data processed: Mar 18, 2026