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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01346748

Enrollment

Registered

2011-05-03

Start date

2011-04-30

Completion date

2013-02-28

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aneurysmal Subarachnoid Hemorrhage

Keywords

vasospasm prevention

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.

Interventions

DRUGstatin

Sinvastatin 80 mg per day - 21 days versus placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Brazil

Contacts

Primary ContactFlavio Romero

frromero@ig.com.br11-34594416

Backup ContactFlávio Romero