Phase 3
N=1,700
Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
Cerebrovascular Accident
Bottom Line
View on ClinicalTrials.gov: NCT00059332 ↗Enrolled (actual)
1,700
Serious AEs
50.6%
Results posted
Aug 2015
Primary outcome: Primary: Modified Rankin Scale — 2; 2 units on a scale — p=0.28
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Magnesium Sulfate (Drug); Normal Saline (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Jeffrey L. Saver
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Rankin Scale |
2; 2 | 0.28 |
| SECONDARY Modified Rankin Score of 0 or 1 |
311; 313 | 0.87 |
| SECONDARY Modified Rankin Score ≤2 |
445; 449 | 0.87 |
| SECONDARY NIH Stroke Scale |
3; 3 | 0.2760 |
| SECONDARY Barthel Index |
95; 90 | 0.3912 |
| SECONDARY Stroke Impact Scale |
65; 67 | 0.3230 |
| SECONDARY Serious Adverse Events |
422; 439 | 0.95 |
| SECONDARY Symptomatic Intracranial Hemorrhage |
28; 18 | 0.12 |
| SECONDARY Mortality |
131; 132 | 0.95 |
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.
Eligibility 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
- Systolic Blood Pressure (SBP) 220
- Known severe renal dysfunction (on dialysis or known chronic creatinine > 3.0)
- Severe respiratory distress (O2 sat /= 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
Data sourced from ClinicalTrials.gov (NCT00059332). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.