Effect of Rosuvastatin in Intracerebral Hemorrhage - Full Text View

Sponsor:	Universidad Autonoma de San Luis Potosí
Information provided by:	Universidad Autonoma de San Luis Potosí
ClinicalTrials.gov Identifier:	NCT00364559

Purpose

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.

Condition	Intervention	Phase
Intracerebral Hemorrhage Stroke	Drug: Rosuvastatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Single Blind (Investigator), Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Resource links provided by NLM:

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:

NIHSSº [ Time Frame: basal and discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survivor [ Time Frame: within 1 month ] [ Designated as safety issue: No ]

Enrollment:	75
Study Start Date:	August 2006
Study Completion Date:	December 2006
Primary Completion Date:	December 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
B: Experimental A, Active B, Historical Register	Drug: Rosuvastatin 20 mg 10 days daily

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

Ages Eligible for Study:	16 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00364559

Locations

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

Sponsors and Collaborators

Universidad Autonoma de San Luis Potosí

Investigators

Study Director:	Ildefonso Rodríguez-Leyva, Neurology	Neurología, Hospital Central "Dr. ignacio Morones Prieto"
Principal Investigator:	Humberto Tapia-Perez, MD	Facultad de Medicina UASLP

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

Publications:

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.

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-Pérez H, Torres-Corzo J, Sanchez-Aguilar M, González-Aguirre D, Rodríguez-Leyva I, Teniente-Sánchez 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.

Responsible Party:	Humberto Tapia
Study ID Numbers:	29-09 ROICH
Study First Received:	August 14, 2006
Last Updated:	March 25, 2009
ClinicalTrials.gov Identifier:	NCT00364559 History of Changes
Health Authority:	Mexico: National Institute of Public Health, Health Secretariat

Keywords provided by Universidad Autonoma de San Luis Potosí:

intracerebral hemorrhage
statins
rosuvastatin
stroke

Additional relevant MeSH terms:

Antimetabolites
Cerebral Hemorrhage
Molecular Mechanisms of Pharmacological Action
Antilipemic Agents
Stroke
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Intracranial Hemorrhages
Hemorrhage
Brain Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Cerebrovascular Disorders
Pharmacologic Actions
Pathologic Processes
Rosuvastatin
Therapeutic Uses
Cardiovascular Diseases

ClinicalTrials.gov processed this record on February 08, 2010