drugset / Trial / NCT00990028
Effect of Rosuvastatin on Cytokines After Traumatic Brain Injury
Phase 1/2
Completed
40 enrolled
Autonomous University of San Luis Potosí
AstraZeneca · collabHospital Central "Dr. Ignacio Morones Prieto" · collab
RandomizedSingle-groupTriple-blindTreatment
Summary
The purpose of this study is to determine whether rosuvastatin could alter the immunological response after head injury by modulating TNF-alpha,IL6,IL-1.
Timeline
- Start
- 2009-08
- Primary completion
- 2011-07
- Completion
- 2011-08
Outcome
Mixed primary results
paper The best-fit mixed model showed a significant effect of rosuvastatin on the reduction of tumor necrosis factor-α levels (p = 0.004). PMID 23289819 ↗
paper Rosuvastatin treatment did not appear to affect the levels of IL-1β, IL-6, and IL-10. PMID 23289819 ↗
Publications
- Background 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.
- Background Tapia-Perez J, 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. doi: 10.1089/neu.2008.0554.
- Background 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. Cent Eur Neurosurg. 2009 Feb;70(1):15-20. doi: 10.1055/s-0028-1082064. Epub 2009 Feb 5.
- Background Tapia-Perez JH, Sanchez-Aguilar M, Schneider T. The role of statins in neurosurgery. Neurosurg Rev. 2010 Jul;33(3):259-70; discussion 270. doi: 10.1007/s10143-010-0259-4. Epub 2010 Apr 29.
- Sanchez-Aguilar M, Tapia-Perez JH, Sanchez-Rodriguez JJ, Vinas-Rios JM, Martinez-Perez P, de la Cruz-Mendoza E, Sanchez-Reyna M, Torres-Corzo JG, Gordillo-Moscoso A. Effect of rosuvastatin on cytokines after traumatic head injury. J Neurosurg. 2013 Mar;118(3):669-75. doi: 10.3171/2012.12.JNS121084. Epub 2013 Jan 4.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rosuvastatin | Small molecule | 20 mg | Oral |