Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329758
Status:
COMPLETED
Last Update Posted:
2010-06-24
First Post:
2006-05-23
Brief Title:
Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
Sponsor:
Universidad Autonoma de San Luis PotosÃ
Organization:
Universidad Autonoma de San Luis PotosÃ
Study Overview
Official Title:
Phase II Study of Rosuvastatins Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury
Status:
COMPLETED
Status Verified Date:
2009-03
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:
None
Brief Summary:
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation
Detailed Description:
The head injury is a frequent problem of health which produces high morbid-mortality Today is the main cause of death and disability between 18 and 40 years In addition it originates expensive expenses in health care systems
Head injury produces damage by primary mechanisms related to impact then by biochemical ways which are activated and they carry to secondary damage Many studies have been conducted for explaining secondary injury the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism The management today is trying to avoid progression in secondary damage without good outcome Many drugs and measures has been ineffective
In the last years has been demonstrated in head injury microvascular damage like stroke Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia frequently for reduction in LDL Experimental and clinical studies in stroke have shown improvement in outcome The toxicity related to statin is myopathy and hepatopathy both with low incidence without fatal cases Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins
We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation furthermore outcome
Head injury produces damage by primary mechanisms related to impact then by biochemical ways which are activated and they carry to secondary damage Many studies have been conducted for explaining secondary injury the majority conclude there is a kind of ischemic lesion related maybe with changes in cerebral flow and metabolism The management today is trying to avoid progression in secondary damage without good outcome Many drugs and measures has been ineffective
In the last years has been demonstrated in head injury microvascular damage like stroke Statins o inhibitors of HMG CoA reductase are drugs used in dyslipidemia frequently for reduction in LDL Experimental and clinical studies in stroke have shown improvement in outcome The toxicity related to statin is myopathy and hepatopathy both with low incidence without fatal cases Rosuvastatin has been postulated be the most powerful with longest life and toxicity similar to another statins
We have designed this study for demonstrate if the administration of rosuvastatin in the first 24 hours and by 10 days has improvement in amnesia and orientation furthermore outcome
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