Sildenafil for Prevention of Cerebral Vasospasm

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Subarachnoid Hemorrhage Cerebral Vasospasm Rupture of Intracranial Aneurysm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo: soluble blue pigment

Soluble blue pigment for placebo controlling.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.

Sildenafil, 75mg daily

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

Group Type EXPERIMENTAL

Sildenafil Citrate, 25 mg, 3 times a day.

Intervention Type DRUG

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Sildenafil, 150 mg daily

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

Group Type EXPERIMENTAL

Sildenafil Citrate 50 mg, 3 times a day

Intervention Type DRUG

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Interventions

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Placebo

Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.

Intervention Type DRUG

Sildenafil Citrate, 25 mg, 3 times a day.

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Intervention Type DRUG

Sildenafil Citrate 50 mg, 3 times a day

Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.

Intervention Type DRUG

Other Intervention Names

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Viagra Viagra

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR