CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,700 enrolled
Drug / intervention
Magnesium Sulfate +1 moredrug
Likely dose
Magnesium sulfate: loading dose 4 grams IV over 15 minutes, followed by maintenance dose 16 grams IV over 24 hoursAI-extracted
Key inclusion· 4
  • ✓Suspected stroke identified by the Los Angeles Prehospital Stroke Screen
  • ✓Age 40–95 years, inclusive
  • ✓Last known well time within 2 hours of treatment initiation
  • ✓Neurologic deficit present for at least 15 minutes
Key exclusion· 9
  • ✕Coma at presentation
  • ✕Rapidly improving neurologic deficit
  • ✕Systolic Blood Pressure <90 or >220 mmHg
  • ✕Severe renal dysfunction (on dialysis or serum creatinine >3.0 mg/dL)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00059332
NCT00059332Phase 3Completed
CompareCT.gov

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

Jeffrey L. Saver·interventional·Posted Apr 24, 2003·Updated Aug 21, 2015

In Brief

A Phase 3 clinical trial evaluating Magnesium Sulfate and Normal Saline for Cerebrovascular Accident. Completed, enrolled 1,700 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCerebrovascular Accident
CountriesUnited States
CollaboratorsNational Institute of Neurological Disorders and Stroke (NINDS)

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 24, 2003
Enrollment StartJan 1, 2005
Primary CompletionMar 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8.2 yearsPosted 23.2 years ago

Interventions

Magnesium Sulfatedrug

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 Salinedrug

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.