Clinical trial NCT00059332: Field Administration of Stroke Therapy - Magnesium (FAST-MAG) Trial
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cerebrovascular Accident
Keywords: stroke
brain attack
magnesium sulfate
neuroprotection
prehospital care
emergency medical services
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2003-04-24
Enrollment: 1700
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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) \< 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

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 3 months after stroke onset
Secondary outcomes:
measure: Modified Rankin Score of 0 or 1
timeFrame: 3 months
measure: Modified Rankin Score ≤2
timeFrame: 3 months
measure: NIH Stroke Scale
timeFrame: 3 months
measure: Barthel Index
timeFrame: 3 months
measure: Stroke Impact Scale
timeFrame: 3 months
measure: Serious Adverse Events
timeFrame: 3 months
measure: Symptomatic Intracranial Hemorrhage
timeFrame: 3 month
measure: Mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza
state: California
Study officials:
affiliation: UCLA School of Medicine, Study Overall Principal Investigator
name: Jeffrey Saver, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UCLA Stroke Center, Co-Principal Investigator
name: Sidney Starkman, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Angeles City Emergency Medical Service, Co-Principal Investigator
name: Marc Eckstein, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Angeles and Orange County Emergency Medical Services Agencies, Co-Principal Investigator
name: Samuel Stratton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Los Angeles County Emergency Medical Service, Co-Principal Investigator
name: Frank Pratt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naidech AM, Shkirkova K, Villablanca JP, Sanossian N, Liebeskind DS, Sharma L, Eckstein M, Stratton S, Conwit R, Hamilton S, Saver JL; FAST-MAG Investigators and Coordinators. Magnesium Sulfate and Hematoma Expansion: An Ancillary Analysis of the FAST-MAG Randomized Trial. Stroke. 2022 May;53(5):1516-1519. doi: 10.1161/STROKEAHA.121.037999. Epub 2022 Apr 5.
citation: Shkirkova K, Wang TT, Vartanyan L, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Conwit R, Saver JL, Sanossian N. Quality of Acute Stroke Care at Primary Stroke Centers Before and After Certification in Comparison to Never-Certified Hospitals. Front Neurol. 2020 Jan 22;10:1396. doi: 10.3389/fneur.2019.01396. eCollection 2019.
citation: Shkirkova K, Schuberg S, Balouzian E, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Sharma L, Liebeskind DS, Conwit R, Saver JL, Sanossian N; FAST-MAG Investigators and Coordinators. Paramedic Global Impression of Change During Prehospital Evaluation and Transport for Acute Stroke. Stroke. 2020 Mar;51(3):784-791. doi: 10.1161/STROKEAHA.119.026392. Epub 2020 Jan 20.
citation: Shkirkova K, Saver JL, Starkman S, Wong G, Weng J, Hamilton S, Liebeskind DS, Eckstein M, Stratton S, Pratt F, Conwit R, Sanossian N; FAST-MAG Trial Coordinators and Investigators. Frequency, Predictors, and Outcomes of Prehospital and Early Postarrival Neurological Deterioration in Acute Stroke: Exploratory Analysis of the FAST-MAG Randomized Clinical Trial. JAMA Neurol. 2018 Nov 1;75(11):1364-1374. doi: 10.1001/jamaneurol.2018.1893.
citation: Chung PW, Kim JT, Sanossian N, Starkmann S, Hamilton S, Gornbein J, Conwit R, Eckstein M, Pratt F, Stratton S, Liebeskind DS, Saver JL; FAST-MAG Investigators and Coordinators. Association Between Hyperacute Stage Blood Pressure Variability and Outcome in Patients With Spontaneous Intracerebral Hemorrhage. Stroke. 2018 Feb;49(2):348-354. doi: 10.1161/STROKEAHA.117.017701. Epub 2018 Jan 4.
citation: Sanossian N, Rosenberg L, Liebeskind DS, Starkman S, Eckstein M, Stratton S, Pratt FD, Hamilton S, Kim-Tenser M, Sharma LK, Restrepo L, Valdes-Suieras M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. A Dedicated Spanish Language Line Increases Enrollment of Hispanics Into Prehospital Clinical Research. Stroke. 2017 May;48(5):1389-1391. doi: 10.1161/STROKEAHA.117.014745. Epub 2017 Apr 7.
citation: Sanossian N, Apibunyopas KC, Liebeskind DS, Starkman S, Burgos AM, Conwit R, Eckstein M, Pratt F, Stratton S, Hamilton S, Saver JL; FAST-MAG (Field Administration of Stroke Therapy-Magnesium) Investigators and Coordinators. Characteristics and Outcomes of Very Elderly Enrolled in a Prehospital Stroke Research Study. Stroke. 2016 Nov;47(11):2737-2741. doi: 10.1161/STROKEAHA.116.013318. Epub 2016 Sep 27.
citation: Kim DH, Saver JL, Starkman S, Liebeskind DS, Ali LK, Restrepo L, Kim-Tenser M, Valdes-Sueiras M, Eckstein M, Pratt F, Stratton S, Hamilton S, Conwit R, Sanossian N; Field Administration of Stroke Therapy-Magnesium (FAST-MAG) Trial Nurse-Coordinators and Investigators. Enrollment Yield and Reasons for Screen Failure in a Large Prehospital Stroke Trial. Stroke. 2016 Jan;47(1):232-5. doi: 10.1161/STROKEAHA.115.011687. Epub 2015 Dec 10.
citation: Sanossian N, Liebeskind DS, Eckstein M, Starkman S, Stratton S, Pratt FD, Koenig W, Hamilton S, Kim-Tenser M, Conwit R, Saver JL; FAST-MAG Investigators and Coordinators. Routing Ambulances to Designated Centers Increases Access to Stroke Center Care and Enrollment in Prehospital Research. Stroke. 2015 Oct;46(10):2886-90. doi: 10.1161/STROKEAHA.115.010264. Epub 2015 Aug 11.
citation: Saver JL, Starkman S, Eckstein M, Stratton SJ, Pratt FD, Hamilton S, Conwit R, Liebeskind DS, Sung G, Kramer I, Moreau G, Goldweber R, Sanossian N; FAST-MAG Investigators and Coordinators. Prehospital use of magnesium sulfate as neuroprotection in acute stroke. N Engl J Med. 2015 Feb 5;372(6):528-36. doi: 10.1056/NEJMoa1408827.