Sildenafil for Prevention of Cerebral Vasospasm (SIPCEVA)

March 24, 2015 updated by: Hospital de Clinicas de Porto Alegre

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035903
        • Hospital de Clínicas de Porto Alegre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo: soluble blue pigment
Soluble blue pigment for placebo controlling.
Drug: Placebo
Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
Experimental: Sildenafil, 75mg daily
Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage.
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.
Other Names:
  • Viagra
Experimental: Sildenafil, 150 mg daily
Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.
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.
Other Names:
  • Viagra

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
New neurological Deficit
Time Frame: From third to 14th day post subarachnoid hemorrhage
Development of clinical symptoms suggestive of vasospasm, which are: afasia, hemiparesis, disorientation, or worsening of consciousness without hydrocephalus or expanding cloth. To access level of consciousness we will use the Glasgow Coma Scale.
From third to 14th day post subarachnoid hemorrhage

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transcranial Ecodoppler
Time Frame: From the third to the 14th day after subarachnoid hemorrhage
Signs of vasospasm in in transcranial ecodoppler.
From the third to the 14th day after subarachnoid hemorrhage
Mortality
Time Frame: From the third to the 14th day before subarachnoid hemorrhage.
General mortality (for any causes).
From the third to the 14th day before subarachnoid hemorrhage.
Side effects
Time Frame: From the third to the 14th day after subarachnoid hemorrhage.
Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.
From the third to the 14th day after subarachnoid hemorrhage.
Time to discharge
Time Frame: From the third day after subarachnoid hemorrhage to discharge.
Time to discharge (period of hospital stay).
From the third day after subarachnoid hemorrhage to discharge.
Rankin Scale
Time Frame: At discharge from the hospital.
Modified Rankin scale at discharge.
At discharge from the hospital.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas de Porto Alegre

Investigators

  • Principal Investigator: André Cerutti Franciscatto, MD, Hospital de Clínicas de Porto Alegre
  • Study Director: Marco Antônio Stefani, DR, Hospital de Clínicas de Porto Alegre
  • Study Chair: Ápio Martins Antunes, DR, Hospital de Clínicas de Porto Alegre
  • Study Chair: Thiago Torres de Ávila, MD, Hospital de Clínicas de Porto Alegre
  • Study Chair: Mateus Lasta Beck, MD, Hospital de Clínicas de Porto Alegre
  • Study Chair: Mateus Franzói, MD, Hospital de Clínicas de Porto Alegre
  • Study Chair: Atahualpa Caue Strapasson, MD, Hospital de Clínicas de Porto Alegre
  • Study Chair: Sílvia Brustolin, DR, Hospital de Clínicas de Porto Alegre
  • Study Chair: Fabiane Backes, MD, Hospital de Clínicas de Porto Alegre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 22, 2010

First Posted (Estimate)

March 24, 2010

Study Record Updates

Last Update Posted (Estimate)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SIPCEVA
  • 09453 (Other Identifier: Etics Comitee of Hospital de Clínicas de Porto Alegre)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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