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Sildenafil for Prevention of Cerebral Vasospasm — SIPCEVA  

Subarachnoid Hemorrhage Clinical Trial

Official title:
Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial

Clinical Trial Summary

A Randomized Clinical Trial with security and dose testing of Sildenafil Citrate in patients with subarachnoid hemorrhage due to a rupture of a cerebral aneurism for prevention of cerebral vasospasm. The cerebral vasospasm is a decrease in blood flow that occurs when the intracranial vessels lose their capability of self-control of dilations and contractions. Patients with subarachnoid hemorrhage without neurological deficits who underwent endovascular or surgical correction of the aneurysm can participate in this trial. They will be randomized to a daily doses of 75 mg of Sildenafil, 150 mg of Sildenafil or Placebo from the third to the 14th day post bleeding. Today there is no proven clinical treatment for prevention of cerebral vasospasm.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01091870
Study type Interventional
Source Hospital de Clinicas de Porto Alegre
Contact
Status Withdrawn
Phase Phase 2
Start date March 2010
View Details
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