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

• Sponsor: University of Sao Paulo General Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT01346748
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arm: 1
• Duration (Months): 22.1
• Patients Per Site Per Month: 3.6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aneurysmal Subarachnoid Hemorrhage	Drug: statin	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Role of Statins in Preventing Cerebral Vasospasm Secondary to Subarachnoid Hemorrhage
• Study Start Date: Apr 1, 2011
• Anticipated Primary Completion Date: Aug 1, 2012
• Anticipated Study Completion Date: Feb 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital das Clínicas	São Paulo		Brazil	05445-000

Sponsors and Collaborators

• University of Sao Paulo General Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01346748
• Other Study ID Numbers: 1268/09
• First Posted: May 3, 2011
• Last Update Posted: May 3, 2011
• Last Verified: Apr 1, 2011

• Keywords provided by , ,: vasospasm prevention
• Additional relevant MeSH terms: Subarachnoid Hemorrhage; Vasospasm, Intracranial; Hemorrhage

Study Results

No Results Posted as of May 3, 2011