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Sponsors and Collaborators: |
Universidad Autonoma de San Luis Potosí Hospital Central "Dr. Ignacio Morones Prieto" AstraZeneca |
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Information provided by: | Universidad Autonoma de San Luis Potosí |
ClinicalTrials.gov Identifier: | NCT00329758 |
The purpose of this study is to determine whether rosuvastatin is effective in the management of moderate head injury by improving amnesia and orientation.
Condition | Intervention | Phase |
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Head Injury |
Drug: rosuvastatin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Single Group Assignment, Efficacy Study |
Official Title: | Phase II Study of Rosuvastatin´s Effect on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Humans With Moderate Head Injury |
Estimated Enrollment: | 20 |
Study Start Date: | July 2006 |
Study Completion Date: | September 2007 |
Arms | Assigned Interventions |
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1, 2: Placebo Comparator
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Drug: rosuvastatin
20 mg oral, during 10 days
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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.
Ages Eligible for Study: | 16 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Mexico | |
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 |
Responsible Party: | Humberto Tapia |
Study ID Numbers: | 26-06ROHI |
Study First Received: | May 23, 2006 |
Last Updated: | February 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00329758 |
Health Authority: | Mexico: National Institute of Public Health, Health Secretariat |
moderate head injury rosuvastatin statin amnesia orientation |
Craniocerebral Trauma Wounds and Injuries Disorders of Environmental Origin Trauma, Nervous System Memory Disorders Cognition Disorders Signs and Symptoms Rosuvastatin |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Neurobehavioral Manifestations Amnesia Delirium |
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents Nervous System Diseases |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |