A Phase 2 interventional study of rosuvastatin and Placebo in Head Injury, sponsored by Universidad Autonoma de San Luis Potosí. Completed at 1 site in Mexico. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2010-06-24.
Sponsored by Universidad Autonoma de San Luis Potosí · Phase 2, Interventional, and Treatment
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
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.
253 studies on the registry are indexed under Craniocerebral Trauma; 45 are open to participants now.
This study's enrollment of 20 is below the median of 87 across 133 interventional studies indexed under Craniocerebral Trauma.
Browse Craniocerebral Trauma studies →Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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Drug: rosuvastatin
Drug: Placebo
20 mg oral, during 10 days
Also known as: Crestor
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
The record gives a start of Jul 2006, a primary completion of Oct 2007 and a completion of Oct 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Rosuvastatin
Universidad Autonoma de San Luis Potosí