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

Cerebrovascular Accident Clinical Trial

— FAST-MAG  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00059332
• Other study ID #: U01NS044364
• Secondary ID: U01NS044364
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2003
• Last updated: July 24, 2015
• Start date: January 2005
• Est. completion date: March 2013

Study information

• Verified date: June 2015
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 95 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebrovascular Accident
• Stroke

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	The Clinical Coordinating Center is: UCLA School of Medicine, 710 Westwood Plaza	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
Jeffrey L. Saver	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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; No significant disability despite symptoms; able to carry out all usual duties and activities; Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance; Moderate disability; requiring some help, but able to walk without assistance; Moderately severe disability; unable to walk without assistance and unable to attend to own bodily needs without assistance; Severe disability; bedridden, incontinent and requiring constant nursing care and attention; Dead	3 months after stroke onset	No
Secondary	Modified Rankin Score of 0 or 1	Minimal or no disability based on the modified Rankin score	3 months	No
Secondary	Modified Rankin Score =2	Functional independence based on modified Rankin score	3 months	No
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	3 months	No
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)	3 months	No
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.; Physical problems; Memory and thinking; Mood and emotions; Communication, reading and understanding; Daily activities; Mobility at home and in the community; Affected hand use; Hobbies and activities participation	3 months	No
Secondary	Serious Adverse Events		3 months	Yes
Secondary	Symptomatic Intracranial Hemorrhage		3 month	Yes
Secondary	Mortality		3 months	Yes

External Links

•   The official FAST-MAG Clinical Trial website