Effect of Rosuvastatin in Intracerebral Hemorrhage
Information source: Universidad Autonoma de San Luis Potosí
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Intracerebral Hemorrhage; Stroke
Intervention: Rosuvastatin (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Universidad Autonoma de San Luis Potosí Official(s) and/or principal investigator(s):
Ildefonso Rodríguez-Leyva, Neurology, Study Director, Affiliation: Neurología, Hospital Central "Dr. ignacio Morones Prieto"
Humberto Tapia-Perez, MD, Principal Investigator, Affiliation: Facultad de Medicina UASLP
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.
Clinical Details
Official title: Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage
Study design: Treatment, Non-Randomized, Single Blind (Investigator), Historical Control, Single Group Assignment, Efficacy Study
Primary outcome: NIHSSº
Secondary outcome: Survivor
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 o 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 for demonstrate if the administration of rosuvastatin in the
first 24 hours and by 14 days has improvement in outcome.
Eligibility
Minimum age: 16 Years.
Maximum age: 80 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Man o Wome >16 and < 80 years with ICH and hospital attention in less 24 hours
- Confirmation by CT scan 3. 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
Locations and Contacts
Hospital Central "Dr. Ignacio Morones Prieto", San Luis Potosi 78240, Mexico
Additional Information
Starting date: August 2006
Ending date: December 2006
Last updated: February 25, 2008
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