Effect of Rosuvastatin on Cytokins After Traumatic Brain Injury - Full Text View

Sponsor:	Universidad Autonoma de San Luis Potosí
Collaborators:	Hospital Central "Dr. Ignacio Morones Prieto" AstraZeneca
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00990028

Purpose

The purpose of this study is to determine whether rosuvastatin coudl affect the immunological response after head injury by modulating TNF-alphaa,IL6,IL-1.

Condition	Intervention	Phase
Head Injury	Drug: Rosuvastatin Drug: Placebo	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Effect of Rosuvastatin on Immunological Markes After Traumatic Brain Injury: Clinical Randomized Double Blind Study Phase 2

Resource links provided by NLM:

MedlinePlus related topics: Traumatic Brain Injury

Drug Information available for: Rosuvastatin calcium Rosuvastatin

U.S. FDA Resources

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

Primary Outcome Measures:

Cytosines (Il-1B, IL-6, TNF-alfa) [ Time Frame: Basal and day 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Galveston Orientation and Amnesia Test [ Time Frame: Days until positive ] [ Designated as safety issue: No ]
Functional outcome by Disability Rating Scale [ Time Frame: at 0 (release), 3 and 6 months ] [ Designated as safety issue: No ]
Lesion on CT scan [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Determination of CK, AST, ALT [ Time Frame: 0, 3, 7 days after randimization ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	40
Study Start Date:	August 2009
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Rosuvastatin: Experimental 20 mg oral during 10 days	Drug: Rosuvastatin 20 mg oral, for 10 days
Placebo: Placebo Comparator	Drug: Placebo 20 mg vehicle

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. All these changes are associated to a immunological response. Up to now some drugs are direted to modulate the immunological system, altough many of them have been ineffective.

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. Many studies have suggested an important immunodulator effect after statins administration, We have previously demonstrated the possible effect of statin on amnesia and disorientation improvement with patients who suffered a moderated head injury (Glasgow 9-13). The aim of this new study is to analyze the possible immunodulator role of statins on head injury.

Eligibility

Ages Eligible for Study:	16 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Man or woman >16 and <60 years with HI less 24 hours in progression and Glasgow between <13
Acceptance of family to participate (first grade).

Exclusion Criteria:

Previous head injury with severe disability
History of neurological or psychiatric disease with severe disability.
Administration 24 hrs previous of: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem,amiodarone.
Very poor possibilities for survival
Use of Administration of THAM, mannitol, barbiturates, corticosteroids, scavengers of free radicals, inhibitors of lipidic peroxidation, indometacin, calcium antagonist, antagonists of neurotransmitters before radomization
isolated lesions 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: NCT00990028

Contacts

Contact: Martin Sanchez-Aguilar, MSc

52 444 82 62 350 ext 519

jemarsan7@hotmail.com

Locations

Mexico
Hospital Central "Dr. Ignacio Morones Prieto"	Recruiting
San Luis Potosi, Mexico, 78420
Contact: Martin Sanchez-Aguilar, MSc 52 444 82 62 350 ext 519 jemarsan7@hotmail.com
Principal Investigator: Jaime G Torres-Corzo, MD
Sub-Investigator: Juan M Vinas-Rios, MD
Sub-Investigator: Patricia Martinez-Perez, MSc

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Hospital Central "Dr. Ignacio Morones Prieto"

AstraZeneca

Investigators

Study Chair:	Antonio Gordillo-Moscoso, PhD	Clinical Epidemiology UASLP
Principal Investigator:	Martin Sanchez-Aguilar, MSc	Clinical epidemiology 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.

Tapia-Perez JH, Sanchez-Aguilar M, Torres-Corzo JG, Gordillo-Moscoso A, Martinez-Perez P, Madeville P, de la Cruz-Mendoza E, Chalita-Williams J. Effect of rosuvastatin on amnesia and disorientation after traumatic brain injury (NCT003229758). J Neurotrauma. 2008 Aug;25(8):1011-7.

Tapia-Perez H, Sanchez-Aguilar M, Torres-Corzo JG, Rodriguez-Leyva I, Gonzalez-Aguirre D, Gordillo-Moscoso A, Chalita-Williams C. Use of statins for the treatment of spontaneous intracerebral hemorrhage: results of a pilot study. Zentralbl Neurochir. 2009 Feb;70(1):15-20. Epub 2009 Feb 5.

Responsible Party:	Clinical Epidemiology UASLP ( Dr. Martin Sanchez )
Study ID Numbers:	28-09ROHI
Study First Received:	October 5, 2009
Last Updated:	October 5, 2009
ClinicalTrials.gov Identifier:	NCT00990028 History of Changes
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

Additional relevant MeSH terms:

Craniocerebral Trauma
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Nervous System Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
Enzyme Inhibitors

Trauma, Nervous System
Anticholesteremic Agents
Brain Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions
Rosuvastatin
Therapeutic Uses
Brain Injuries

ClinicalTrials.gov processed this record on February 08, 2010