Clinical trial NCT00364559: Effect of Rosuvastatin in Intracerebral Hemorrhage
Official title: Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Stroke
Keywords: intracerebral hemorrhage
statins
rosuvastatin
stroke
Lead sponsor: Universidad Autonoma de San Luis Potosí
Sponsor class: OTHER
First posted: 2006-08-15
Enrollment: 75
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Men or Women \>16 and \< 80 years with ICH and hospital attention in less 24 hours
* Confirmation by CT scan
* Acceptance by family

Exclusion Criteria:

* History of stroke
* History of neurological disease, head injury o psychiatric disorder with disability
* Glasgow less than 9
* Administration 24 hours before: fibrates, niacin, ciclosporin, azoles, macrolides, inhibitors of protease, nefazodone, verapamil, diltiazem, amiodarone.
* Use before hospital of: mannitol, barbiturates, corticosteroids, calcium antagonists
* Any lesion which needs surgery
* Allergy to drug used
* cerebral death
* Hepatic disease (Child B y C) or myopathy (or) history
* Management in other Hospital
* Pregnancy
* ICH major than 60 ml.
* hypothyroidism

Primary outcomes:
measure: NIHSSº
timeFrame: basal and discharge
Secondary outcomes:
measure: Survivor
timeFrame: within 1 month
Other outcomes:
Locations:
city: San Luis Potosi
country: Mexico
facility: Hospital Central "Dr. Ignacio Morones Prieto"
Study officials:
affiliation: Neurología, Hospital Central "Dr. ignacio Morones Prieto"
name: Ildefonso Rodríguez-Leyva, Neurology
role: STUDY_DIRECTOR
affiliation: Facultad de Medicina UASLP
name: Humberto Tapia-Perez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Tapia-Perez H, Torres-Corzo J, Sanchez-Aguilar M, Gonzalez-Aguirre D, Rodriguez-Leyva I, Teniente-Sanchez AE, Gordillo-Moscoso A. [A clinical-epidemiological approximation to intracerebral hemorrhage in a Mexican hospital: analysis of factors associated to mortality]. Rev Neurol. 2008 Jan 16-31;46(2):67-72. Spanish.
citation: 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.