The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

NCT ID: NCT01346748

Last Updated: 2011-05-03

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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-02-28

Brief Summary

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Delayed ischemia caused by cerebral vasospasm remains a common cause of morbidity and mortality after aneurysmal subarachnoid hemorrhage. A great deal of drugs has been tested in the last years. Phase II randomized clinical trials have demonstrated that statin decreases the incidence of symptomatic cerebral vasospasm after spontaneous subarachnoid hemorrhage. Clinical, double blind, randomized controlled trials with placebo. Discussion: Even though some articles have shown that statins provide better prognosis, some issues remain in debate, e.g., treatment duration and the choice of the statin.

Detailed Description

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Conditions

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Aneurysmal Subarachnoid Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Statin

Group Type EXPERIMENTAL

statin

Intervention Type DRUG

Sinvastatin 80 mg per day - 21 days versus placebo

Interventions

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statin

Sinvastatin 80 mg per day - 21 days versus placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age between 18 and 65 years old, Hunt-hess scale \< 3

Exclusion Criteria

* Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Neurology department of São Paulo University

Principal Investigators

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Eberval Figueiredo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

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Hospital das Clínicas

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Flavio Romero

Role: CONTACT

11-34594416

Flávio Romero

Role: CONTACT

11-34594416

Facility Contacts

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Flávio Romero

Role: primary

11-34594416

Other Identifiers

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1268/09

Identifier Type: -

Identifier Source: org_study_id

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