Effect of Rosuvastatin in Intracerebral Hemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Rosuvastatin on Outcome by NIHSS After Intracerebral Hemorrhage

Conditions
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Intracerebral Hemorrhage, Stroke

Intervention / Treatment
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* Drug: Rosuvastatin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B<br>A, Active B, Historical Register | Drug: Rosuvastatin<br>* 20 mg 10 days daily<br>* Other names: Crestor;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIHSSº |  | basal and discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivor |  | within 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracerebral hemorrhage, statins, rosuvastatin, stroke