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

This study has been completed.
Sponsor:
Collaborator:
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  
Number of Participants  
[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)  
National Institute of Health Stroke Scale (NIHSS) at hospital arrival [2]
[units: units on a scale]
Mean (Standard Deviation)
  11.2  (9.8)     11.5  (9.9)     11.3  (9.9)  
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  
[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.
[2]

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




  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


No publications provided by University of California, Los Angeles

Publications automatically indexed to this study:

Responsible Party: Jeffrey L. Saver, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00059332     History of Changes
Other Study ID Numbers: U01NS44364, U01NS044364
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