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CompletedNCT00364559Updated Mar 26, 2009

Effect of Rosuvastatin in Intracerebral Hemorrhage

A Phase 2 interventional study of Rosuvastatin in Intracerebral Hemorrhage and Stroke, sponsored by Universidad Autonoma de San Luis Potosí. Completed at 1 site in Mexico. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-03-26.

Sponsored by Universidad Autonoma de San Luis Potosí · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Non-randomized
Ages
16 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Intracerebral Hemorrhage
  • Stroke

Keywords

  • intracerebral hemorrhage
  • statins
  • rosuvastatin
  • stroke
03

In context

Cerebral Hemorrhage

476 studies on the registry are indexed under Cerebral Hemorrhage; 181 are open to participants now.

This study's enrollment of 75 is below the median of 100 across 287 interventional studies indexed under Cerebral Hemorrhage.

Browse Cerebral Hemorrhage studies →

Lead sponsor

Universidad Autonoma de San Luis Potosí is the lead sponsor of 40 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
75 participants (actual)

Study arms

  • Experimental
    B

    A, Active B, Historical Register

    Drug: Rosuvastatin

Interventions

  • DrugRosuvastatin

    20 mg 10 days daily

    Also known as: Crestor

06

What researchers measure

Primary outcomes

  1. NIHSSº

    Time frame: basal and discharge

Secondary outcomes

  1. Survivor

    Time frame: within 1 month

07

Study locations

1 site
  • Hospital Central "Dr. Ignacio Morones Prieto"
    San Luis Potosi, 78240, Mexico
08

References and documents

Publications

  • 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. PubMed 17899518 ↗
  • 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. PubMed 18247276 ↗
  • 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. PubMed 19197830 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 26, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00364559
Lead sponsor
Universidad Autonoma de San Luis Potosí
First posted
Aug 15, 2006
Start date
Aug 2006
Primary completion
Dec 2006
Completion
Dec 2006
Last update
Mar 26, 2009

Study contacts

Ildefonso Rodríguez-Leyva, Neurology
study director · Neurología, Hospital Central "Dr. ignacio Morones Prieto"
Humberto Tapia-Perez, MD
principal investigator · Facultad de Medicina UASLP
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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