Effect of Rosuvastatin on Amnesia and Orientation Through Galveston Outcome Amnesia Test in Moderate Head Injury - Full Text View

Sponsors and Collaborators:	Universidad Autonoma de San Luis Potosí Hospital Central "Dr. Ignacio Morones Prieto" AstraZeneca
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00329758

Purpose

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
Head Injury	Drug: rosuvastatin	Phase II

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Rosuvastatin Rosuvastatin calcium

U.S. FDA Resources

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

Further study details as provided by Universidad Autonoma de San Luis Potosí:

Primary Outcome Measures:

Galveston Orientation and Amnesia Test [ Time Frame: Days in be positive ] [ Designated as safety issue: No ]
Lesion by CT scan [ Time Frame: admission and 72 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes Glasgow Coma Scale [ Time Frame: Basal, 1, 3, 5 days ] [ Designated as safety issue: No ]
Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release) and 3 months ] [ Designated as safety issue: No ]
Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ] [ Designated as safety issue: No ]
acute reanal Insuficience [ Time Frame: Periode of medication (10 days) ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	20
Study Start Date:	July 2006
Study Completion Date:	September 2007

Arms	Assigned Interventions
1, 2: Placebo Comparator Activo Placebo	Drug: rosuvastatin 20 mg oral, during 10 days

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.

Eligibility

Ages Eligible for Study:	16 Years to 50 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman >16 and <50 years with HI less 24 hours in progression and Glasgow between 9 y 12.
Man or woman >16 and <50 years with HI and Glasgow l3, with lesions in TC scan.
Acceptance of family to participate (first grade).

Exclusion Criteria:

History of HI with disability
History of neurological or psychiatric disease with disability.
Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
Existence of systemic injury with life in compromise (massive bleeding, exposition of bone in fracture, hepatic or splenic laceration or in great vessels and shock).
Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters
Existence of intracranial lesion which needs surgery.
Lesions not classifiable or in brainstem.
Allergy to the drug.
Hepatopathy or myopathy (or) history of this, or clinical data of hepatic disease.
Management previous in other Hospital.
Pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00329758

Locations

Mexico
Hospital Central "Dr. Ignacio Morones Prieto"
San Luis Potosi, Mexico, 78240

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Hospital Central "Dr. Ignacio Morones Prieto"

AstraZeneca

Investigators

Study Director:	Jaime Torres-Corzo, Neurosurgeon	Hospital Central "Dr. Ignacio Morones Prieto"
Principal Investigator:	Humberto Tapia-Perez, MD	Facultad de Medicina UASLP

More Information

Publications:

Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo J, Rodriguez-Leyva I, Herrera-Gonzalez LB. [Statins and brain protection mechanisms.] Rev Neurol. 2007 Sep 16-30;45(6):359-64. Spanish.

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

Keywords provided by Universidad Autonoma de San Luis Potosí:

moderate head injury
rosuvastatin
statin
amnesia
orientation

Study placed in the following topic categories:

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

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
Nervous System Diseases

Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009