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Effect of Rosuvastatin in Intracerebral Hemorrhage

Primary Purpose

Intracerebral Hemorrhage, Stroke

Status
Completed
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Rosuvastatin
Sponsored by
Universidad Autonoma de San Luis Potosí
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intracerebral Hemorrhage focused on measuring intracerebral hemorrhage, statins, rosuvastatin, stroke

Eligibility Criteria

16 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Central "Dr. Ignacio Morones Prieto"

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

B

Arm Description

A, Active B, Historical Register

Outcomes

Primary Outcome Measures

NIHSSº

Secondary Outcome Measures

Survivor

Full Information

First Posted
August 14, 2006
Last Updated
March 25, 2009
Sponsor
Universidad Autonoma de San Luis Potosí
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1. Study Identification

Unique Protocol Identification Number
NCT00364559
Brief Title
Effect of Rosuvastatin in Intracerebral Hemorrhage
Official Title
Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universidad Autonoma de San Luis Potosí

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intracerebral Hemorrhage, Stroke
Keywords
intracerebral hemorrhage, statins, rosuvastatin, stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
B
Arm Type
Experimental
Arm Description
A, Active B, Historical Register
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Crestor
Intervention Description
20 mg 10 days daily
Primary Outcome Measure Information:
Title
NIHSSº
Time Frame
basal and discharge
Secondary Outcome Measure Information:
Title
Survivor
Time Frame
within 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ildefonso Rodríguez-Leyva, Neurology
Organizational Affiliation
Neurología, Hospital Central "Dr. ignacio Morones Prieto"
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Humberto Tapia-Perez, MD
Organizational Affiliation
Facultad de Medicina UASLP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Central "Dr. Ignacio Morones Prieto"
City
San Luis Potosi
ZIP/Postal Code
78240
Country
Mexico

12. IPD Sharing Statement

Citations:
PubMed Identifier
17899518
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.
Results Reference
background
PubMed Identifier
18247276
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.
Results Reference
background
PubMed Identifier
19197830
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.
Results Reference
result

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Effect of Rosuvastatin in Intracerebral Hemorrhage

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