The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2011
CompletedFirst Submitted
Initial submission to the registry
April 27, 2011
CompletedFirst Posted
Study publicly available on registry
May 3, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMay 3, 2011
April 1, 2011
1.3 years
April 27, 2011
May 2, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Study Arms (1)
Statin
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Age between 18 and 65 years old, Hunt-hess scale \< 3
You may not qualify if:
- Liver disfunction, previous use of statin, hunt-hess scale 4 or 5.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas
São Paulo, São Paulo, 05445-000, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eberval Figueiredo, PhD
University of Sao Paulo
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
April 27, 2011
First Posted
May 3, 2011
Study Start
April 1, 2011
Primary Completion
August 1, 2012
Study Completion
February 1, 2013
Last Updated
May 3, 2011
Record last verified: 2011-04