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

Phase 4

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Drug: statin

• Registration Number: NCT01346748
• Lead Sponsor: University of Sao Paulo General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-04
• Study Start: 2011-04
• Study First Submitted: 2011-04-27
• Study First Submitted QC: 2011-05-02
• Last Update Submitted: 2011-05-02
• Study First Posted: 2011-05-03
• Last Update Posted: 2011-05-03
• Primary Completion: 2012-08
• Study Completion: 2013-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Statin	statin	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

Hospital das Clínicas; 🇧🇷 São Paulo, Brazil