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

U

University of Sao Paulo General Hospital

Status and phase

Unknown
Phase 4

Conditions

Aneurysmal Subarachnoid Hemorrhage

Treatments

Drug: statin

Study type

Interventional

Funder types

Other

Identifiers

NCT01346748
1268/09

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

80 participants in 1 patient group

Statin
Experimental group
Treatment:
Drug: statin

Trial contacts and locations

1

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Central trial contact

Flávio Romero; Flavio Romero

Data sourced from clinicaltrials.gov

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