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

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00059332
First received: April 23, 2003
Last updated: July 24, 2015
Last verified: June 2015
Results First Received: June 9, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cerebrovascular Accident
Interventions: Drug: Magnesium Sulfate
Drug: Normal Saline

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
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.
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.

Participant Flow:   Overall Study
    Normal Saline   Magnesium Sulfate
STARTED   843   857 
COMPLETED   840   855 
NOT COMPLETED   3   2 
Withdrawal by Subject                2                1 
Lost to Follow-up                1                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
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.
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.
Total Total of all reporting groups

Baseline Measures
   Normal Saline   Magnesium Sulfate   Total 
Overall Participants Analyzed 
[Units: Participants]
 843   857   1700 
Age 
[Units: Years]
Mean (Standard Deviation)
 69  (13.6)   69  (13.4)   69  (13.5) 
Age, Customized 
[Units: Participants]
     
<60 years of age   239   242   481 
60-75 years of age   284   278   562 
>75 years of age   320   337   657 
Gender 
[Units: Participants]
     
Female   367   358   725 
Male   476   499   975 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   206   196   402 
Not Hispanic or Latino   637   661   1298 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   5   4   9 
Asian   62   77   139 
Native Hawaiian or Other Pacific Islander   2   6   8 
Black or African American   113   106   219 
White   661   664   1325 
More than one race   0   0   0 
Unknown or Not Reported   0   0   0 
Medical History 
[Units: Participants]
     
Hypertension   648   671   1319 
Diabetes   188   189   377 
Hyperlipidimia   407   398   805 
Atrial fibrillation   175   194   369 
Myocardial infarction   82   94   176 
Tobacco use   158   139   297 
Alcohol use   328   326   654 
Prestroke function - Living at home 
[Units: Participants]
 823   834   1657 
Los Angeles Motor Scale at hospital arrival [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 3.3  (2.2)   3.4  (2.3)   3.4  (2.3) 
[1] The Los Angeles Motor Scale (LAMS) Facial droop (sub score is 0-1) Absent 0 Present 1 Arm drift (sub score range is 0-2) Absent 0 Drifts down 1 Falls rapidly 2 Grip strength (sub score range is 0-2) Normal 0 Weak grip 1 No grip 2 The sub scales are summed to obtain a total score. Total Score Range is 0-5. Lower values on the scale represent better outcomes and Higher values on the scale represent worse outcomes.
National Institute of Health Stroke Scale (NIHSS) at hospital arrival [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 11.2  (9.8)   11.5  (9.9)   11.3  (9.9) 
[1]

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

Intravenous tissue plasminogen activator (t-PA) in patients with cerebral ischemia 
[Units: Participants]
 205   242   447 
Final Diagnosis 
[Units: Participants]
     
Cerebral Ischemia   613   632   1245 
Intracranial Hemorrhage   192   195   387 
Cerebrovascular-mimicking condition   37   30   67 


  Outcome Measures
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1.  Primary:   Modified Rankin Scale   [ Time Frame: 3 months after stroke onset ]

2.  Secondary:   Modified Rankin Score of 0 or 1   [ Time Frame: 3 months ]

3.  Secondary:   Modified Rankin Score ≤2   [ Time Frame: 3 months ]

4.  Secondary:   NIH Stroke Scale   [ Time Frame: 3 months ]

5.  Secondary:   Barthel Index   [ Time Frame: 3 months ]

6.  Secondary:   Stroke Impact Scale   [ Time Frame: 3 months ]

7.  Secondary:   Serious Adverse Events   [ Time Frame: 3 months ]

8.  Secondary:   Symptomatic Intracranial Hemorrhage   [ Time Frame: 3 month ]

9.  Secondary:   Mortality   [ Time Frame: 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Jeffrey Saver
Organization: UCLA, David Geffen School of Medicine
phone: 310-794-6379
e-mail: jsaver@mednet.ucla.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00059332     History of Changes
Other Study ID Numbers: U01NS044364 ( US NIH Grant/Contract Award Number )
Study First Received: April 23, 2003
Results First Received: June 9, 2015
Last Updated: July 24, 2015
Health Authority: United States: Food and Drug Administration