Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury
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|ClinicalTrials.gov Identifier: NCT00329758|
Recruitment Status : Completed
First Posted : May 25, 2006
Last Update Posted : June 24, 2010
|Condition or disease||Intervention/treatment||Phase|
|Head Injury||Drug: rosuvastatin Drug: Placebo||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury|
|Study Start Date :||July 2006|
|Actual Primary Completion Date :||October 2007|
|Actual Study Completion Date :||October 2007|
|Active Comparator: 1||
20 mg oral, during 10 days
Other Name: Crestor
|Placebo Comparator: 2||Drug: Placebo|
- Galveston Orientation and Amnesia Test [ Time Frame: Days in be positive ]
- Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release) and 3 months ]
- Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ]
- acute renal Insuficience [ Time Frame: Periode of medication (10 days) ]
- Lesion on CT scan [ Time Frame: 72 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00329758
|Hospital Central "Dr. Ignacio Morones Prieto"|
|San Luis Potosi, Mexico, 78240|
|Study Director:||Jaime Torres-Corzo, Neurosurgeon||Hospital Central "Dr. Ignacio Morones Prieto"|
|Principal Investigator:||Humberto Tapia-Perez, MD||Facultad de Medicina UASLP|