Effect of Rosuvastatin in Intracerebral Hemorrhage

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2006-12-31

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.

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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.

Conditions

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Intracerebral Hemorrhage Stroke

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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B

A, Active B, Historical Register

Group Type EXPERIMENTAL

Rosuvastatin

Intervention Type DRUG

20 mg 10 days daily

Interventions

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Rosuvastatin

20 mg 10 days daily

Intervention Type DRUG

Other Intervention Names

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Crestor

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

Minimum Eligible Age

16 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No