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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Sao Paulo General Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01346748
First received: April 27, 2011
Last updated: May 2, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Aneurysmal Subarachnoid Hemorrhage
Drug: statin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Diference in clinical outcome between patients who will or won't receive sinvastatin.


Estimated Enrollment: 80
Study Start Date: April 2011
Estimated Study Completion Date: February 2013
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Statin Drug: statin
Sinvastatin 80 mg per day - 21 days versus placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346748

Contacts
Contact: Flavio Romero 11-34594416 frromero@ig.com.br
Contact: Flávio Romero 11-34594416 frromero@ig.com.br

Locations
Brazil
Hospital das Clínicas Recruiting
São Paulo, Brazil, 05445-000
Contact: Flávio Romero    11-34594416    frromero@ig.com.br   
Principal Investigator: Eberval Figueiredo         
Principal Investigator: Flavio Romero         
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Eberval Figueiredo, PhD University of São Paulo
  More Information

No publications provided

Responsible Party: Eberval Gadelha Figueiredo, Neurology department of São Paulo University
ClinicalTrials.gov Identifier: NCT01346748     History of Changes
Other Study ID Numbers: 1268/09
Study First Received: April 27, 2011
Last Updated: May 2, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
vasospasm prevention

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Enzyme Inhibitors
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014