Effect of Rosuvastatin in Intracerebral Hemorrhage
The purpose of this study is to determine whether rosuvastatin is effective in the management of acute phase of intracerebral hemorrhage and if it impact outcome by NIHSS.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|Official Title:||Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage|
- NIHSSº [ Time Frame: basal and discharge ] [ Designated as safety issue: No ]
- Survivor [ Time Frame: within 1 month ] [ Designated as safety issue: No ]
|Study Start Date:||August 2006|
|Study Completion Date:||December 2006|
|Primary Completion Date:||December 2006 (Final data collection date for primary outcome measure)|
A, Active B, Historical Register
20 mg 10 days daily
Other Name: Crestor
The intracerebral hemorrhage (ICH) is a frequent problem of health, with high morbid-mortality. In addition it originates expensive expenses in health care systems.
ICH produces damage by mass effect, then by biochemical ways which are activated and they carry to secondary damage. Many studies have been conducted for explaining secondary injury, now we know there are ischemic changes related maybe with changes in cerebral flow and metabolism, in addition to activate inflammatory ways. Many drugs and measures has been ineffective for getting best outcome, without success.
Statins or inhibitors of HMG CoA reductase are drugs used in dyslipidemia, frequently for reduction in LDL. Experimental and clinical studies in stroke and ICH 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 to demonstrate if the administration of rosuvastatin in the first 24 hours and by 14 days has improvement in outcome.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00364559
|Hospital Central "Dr. Ignacio Morones Prieto"|
|San Luis Potosi, Mexico, 78240|
|Study Director:||Ildefonso Rodríguez-Leyva, Neurology||Neurología, Hospital Central "Dr. ignacio Morones Prieto"|
|Principal Investigator:||Humberto Tapia-Perez, MD||Facultad de Medicina UASLP|