Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00059332
Status:
COMPLETED
Last Update Posted:
2015-08-21
First Post:
2003-04-23
Brief Title:
Field Administration of Stroke Therapy - Magnesium FAST-MAG Trial
Sponsor:
Jeffrey L Saver
Organization:
University of California Los Angeles
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FAST-MAG
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 750000 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01NS044364 | NIH | None | httpsreporternihgovquickSearchU01NS044364 |