Effect of Rosuvastatin in Intracerebral Hemorrhage

Universidad Autonoma de San Luis Potosí

Status and phase: Completed; Phase 2

Conditions: Stroke; Intracerebral Hemorrhage

Treatments: Drug: Rosuvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00364559

29-09 ROICH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 patients

Sex: All

Ages: 16 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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75 participants in 1 patient group

B

Experimental group

Description:

A, Active B, Historical Register

Treatment:

Drug: Rosuvastatin