NCT00364559

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

March 26, 2009

Status Verified

March 1, 2009

Enrollment Period

4 months

First QC Date

August 14, 2006

Last Update Submit

March 25, 2009

Conditions

Intracerebral HemorrhageStroke

Keywords

intracerebral hemorrhagestatinsrosuvastatinstroke

Outcome Measures

Primary Outcomes (1)

  • NIHSSº

    basal and discharge

Secondary Outcomes (1)

  • Survivor

    within 1 month

Study Arms (1)

B

EXPERIMENTAL

A, Active B, Historical Register

Drug: Rosuvastatin

Interventions

RosuvastatinDRUG

20 mg 10 days daily

Also known as: Crestor
B

Eligibility Criteria

Age16 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Central "Dr. Ignacio Morones Prieto"

San Luis Potosí City, San Luis Potosí, 78240, Mexico

Location

Related Publications (3)

  • 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.

    PMID: 17899518BACKGROUND

  • 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.

    PMID: 18247276BACKGROUND

  • 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.

    PMID: 19197830RESULT

MeSH Terms

Conditions

Cerebral HemorrhageStroke

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ildefonso Rodríguez-Leyva, Neurology

    Neurología, Hospital Central "Dr. ignacio Morones Prieto"

    STUDY DIRECTOR

  • Humberto Tapia-Perez, MD

    Facultad de Medicina UASLP

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 14, 2006

First Posted

August 15, 2006

Study Start

August 1, 2006

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

March 26, 2009

Record last verified: 2009-03

Locations

ME(1)