Sildenafil for Prevention of Cerebral Vasospasm (SIPCEVA)

Hospital de Clinicas de Porto Alegre

Status and phase: Withdrawn; Phase 2

Conditions: Subarachnoid Hemorrhage; Rupture of Intracranial Aneurysm; Cerebral Vasospasm

Treatments: Drug: Sildenafil Citrate 50 mg, 3 times a day; Drug: Placebo; Drug: Sildenafil Citrate, 25 mg, 3 times a day.

Study type: Interventional

Funder types: Other

Identifiers

NCT01091870

SIPCEVA

09453 (Other Identifier)

Details and patient eligibility

About

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.

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females between 20 and 80 years old
• Subarachnoid hemorrhage confirmed by CT with Fisher III or IV criteria (blood in cisterns larger than 1 mm with or without blood in the ventricular system).
• Aneurysm detected in the conventional angiography, or angio-CT or angio - MRI.
• Patient underwent surgery for clipping or endovascular treatment in the first 72 hours after the ictus.
• Consent form signed by the patient or legal responsible.

Exclusion criteria

• Patient (or legal responsible) refuses to participate.
• Impossibility to collect consent form.
• Hemodynamical instability.
• Previous cardiac ischemic disease.
• History of cardiac arrhythmia within the last 6 months.
• History of Retinitis Pigmentosa.
• Previous use of drugs witch can interact with sildenafil (specially nitrates).
• Pregnancy.
• Known hypersensibility to Sildenafil.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 3 patient groups, including a placebo group

Placebo: soluble blue pigment

Placebo Comparator group

Description:

Soluble blue pigment for placebo controlling.

Treatment:

Drug: Placebo

Sildenafil, 75mg daily

Experimental group

Description:

Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage.

Treatment:

Drug: Sildenafil Citrate, 25 mg, 3 times a day.

Sildenafil, 150 mg daily

Experimental group

Description:

Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.

Treatment:

Drug: Sildenafil Citrate 50 mg, 3 times a day