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Sildenafil for Prevention of Cerebral Vasospasm (SIPCEVA)

Primary Purpose

Subarachnoid Hemorrhage, Cerebral Vasospasm, Rupture of Intracranial Aneurysm

Status
Withdrawn
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Placebo
Sildenafil Citrate, 25 mg, 3 times a day.
Sildenafil Citrate 50 mg, 3 times a day
Sponsored by
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Subarachnoid Hemorrhage focused on measuring Aneurysm, Vasospasm, sildenafil, Viagra

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital de Clínicas de Porto Alegre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo: soluble blue pigment

Sildenafil, 75mg daily

Sildenafil, 150 mg daily

Arm Description

Soluble blue pigment for placebo controlling.

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

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

Outcomes

Primary Outcome Measures

New neurological Deficit
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.

Secondary Outcome Measures

Transcranial Ecodoppler
Signs of vasospasm in in transcranial ecodoppler.
Mortality
General mortality (for any causes).
Side effects
Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.
Time to discharge
Time to discharge (period of hospital stay).
Rankin Scale
Modified Rankin scale at discharge.

Full Information

First Posted
March 17, 2010
Last Updated
March 24, 2015
Sponsor
Hospital de Clinicas de Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT01091870
Brief Title
Sildenafil for Prevention of Cerebral Vasospasm
Acronym
SIPCEVA
Official Title
Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Absence of inclusion criteria
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subarachnoid Hemorrhage, Cerebral Vasospasm, Rupture of Intracranial Aneurysm
Keywords
Aneurysm, Vasospasm, sildenafil, Viagra

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo: soluble blue pigment
Arm Type
Placebo Comparator
Arm Description
Soluble blue pigment for placebo controlling.
Arm Title
Sildenafil, 75mg daily
Arm Type
Experimental
Arm Description
Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage.
Arm Title
Sildenafil, 150 mg daily
Arm Type
Experimental
Arm Description
Sildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate, 25 mg, 3 times a day.
Other Intervention Name(s)
Viagra
Intervention Description
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Intervention Type
Drug
Intervention Name(s)
Sildenafil Citrate 50 mg, 3 times a day
Other Intervention Name(s)
Viagra
Intervention Description
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
Primary Outcome Measure Information:
Title
New neurological Deficit
Description
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.
Time Frame
From third to 14th day post subarachnoid hemorrhage
Secondary Outcome Measure Information:
Title
Transcranial Ecodoppler
Description
Signs of vasospasm in in transcranial ecodoppler.
Time Frame
From the third to the 14th day after subarachnoid hemorrhage
Title
Mortality
Description
General mortality (for any causes).
Time Frame
From the third to the 14th day before subarachnoid hemorrhage.
Title
Side effects
Description
Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.
Time Frame
From the third to the 14th day after subarachnoid hemorrhage.
Title
Time to discharge
Description
Time to discharge (period of hospital stay).
Time Frame
From the third day after subarachnoid hemorrhage to discharge.
Title
Rankin Scale
Description
Modified Rankin scale at discharge.
Time Frame
At discharge from the hospital.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
André Cerutti Franciscatto, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marco Antônio Stefani, DR
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ápio Martins Antunes, DR
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Thiago Torres de Ávila, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mateus Lasta Beck, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mateus Franzói, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Atahualpa Caue Strapasson, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sílvia Brustolin, DR
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Fabiane Backes, MD
Organizational Affiliation
Hospital de Clínicas de Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90035903
Country
Brazil

12. IPD Sharing Statement

Links:
URL
http://www.hcpa.ufrgs.br
Description
Official Site of Hospital de Clínicas de Porto Alegre

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Sildenafil for Prevention of Cerebral Vasospasm

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