Effect of Rosuvastatin in Intracerebral Hemorrhage

Phase 2

Completed

• Conditions: Intracerebral Hemorrhage; Stroke
• Interventions: Drug: Rosuvastatin

• Registration Number: NCT00364559
• Lead Sponsor: Universidad Autonoma de San Luis Potosí

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.

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.

Study Timeline

• Study Start: 2006-08
• Study First Submitted: 2006-08-14
• Study First Submitted QC: 2006-08-14
• Study First Posted: 2006-08-15
• Primary Completion: 2006-12
• Study Completion: 2006-12
• Status Verified: 2009-03
• Last Update Submitted: 2009-03-25
• Last Update Posted: 2009-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
B	Rosuvastatin	A, Active B, Historical Register

Primary Outcome Measures

Name	Time	Method
NIHSSº	basal and discharge

Secondary Outcome Measures

Name	Time	Method
Survivor	within 1 month

Trial Locations

Locations (1)

Hospital Central "Dr. Ignacio Morones Prieto"; 🇲🇽 San Luis Potosi, Mexico