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

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01346748
• Other study ID #: 1268/09
• Status: Recruiting
• Phase: Phase 4
• First received: April 27, 2011
• Last updated: May 2, 2011
• Start date: April 2011
• Est. completion date: February 2013

Study information

• Verified date: April 2011
• Source: University of Sao Paulo General Hospital
• Contact: Flavio Romero
• Phone: 11-34594416
• Email: frromero[@]ig.com.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• statin
Sinvastatin 80 mg per day - 21 days versus placebo

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes