Back to resultsThe Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Unknown status
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
statin
Sponsored by
About this trial
This is an interventional prevention trial for Aneurysmal Subarachnoid Hemorrhage focused on measuring vasospasm prevention
Eligibility 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.
Sites / Locations
- Hospital das ClínicasRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Statin
Arm Description
Outcomes
Primary Outcome Measures
The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage
Diference in clinical outcome between patients who will or won't receive sinvastatin.
Secondary Outcome Measures
Full Information
NCT ID
NCT01346748
First Posted
April 27, 2011
Last Updated
May 2, 2011
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01346748
Brief Title
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Official Title
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
February 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
Keywords
vasospasm prevention
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Statin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
statin
Intervention Description
Sinvastatin 80 mg per day - 21 days versus placebo
Primary Outcome Measure Information:
Title
The role of statins in preventing cerebral vasospasm secondary to subarachnoid hemorrhage
Description
Diference in clinical outcome between patients who will or won't receive sinvastatin.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavio Romero
Phone
11-34594416
Email
frromero@ig.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Flávio Romero
Phone
11-34594416
Email
frromero@ig.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eberval Figueiredo, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas
City
São Paulo
ZIP/Postal Code
05445-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flávio Romero
Phone
11-34594416
Email
frromero@ig.com.br
First Name & Middle Initial & Last Name & Degree
Eberval Figueiredo
First Name & Middle Initial & Last Name & Degree
Flavio Romero
12. IPD Sharing Statement
Learn more about this trial
The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
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