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

May 2, 2011 updated by: University of Sao Paulo General Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
      • São Paulo, Brazil, 05445-000
        • Recruiting
        • Hospital das Clínicas
        • Contact:
        • Principal Investigator:
          • Eberval Figueiredo
        • Principal Investigator:
          • Flavio Romero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Statin
Drug: statin
Sinvastatin 80 mg per day - 21 days versus placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage
Time Frame: 6 months
Diference in clinical outcome between patients who will or won't receive sinvastatin.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Eberval Figueiredo, PhD, University of Sao Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Anticipated)

August 1, 2012

Study Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

May 2, 2011

First Posted (Estimate)

May 3, 2011

Study Record Updates

Last Update Posted (Estimate)

May 3, 2011

Last Update Submitted That Met QC Criteria

May 2, 2011

Last Verified

April 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1268/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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