Sildenafil for Prevention of Cerebral Vasospasm (SIPCEVA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Hospital de Clinicas de Porto Alegre.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01091870
First received: March 17, 2010
Last updated: March 22, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention Phase
Subarachnoid Hemorrhage
Cerebral Vasospasm
Rupture of Intracranial Aneurysm
Drug: Placebo
Drug: Sildenafil Citrate, 25 mg, 3 times a day.
Drug: Sildenafil Citrate 50 mg, 3 times a day
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • New neurological Deficit [ Time Frame: From third to 14th day post subarachnoid hemorrhage ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: From the third to the 14th day after subarachnoid hemorrhage ] [ Designated as safety issue: Yes ]
    Signs of vasospasm in in transcranial ecodoppler.

  • Mortality [ Time Frame: From the third to the 14th day before subarachnoid hemorrhage. ] [ Designated as safety issue: Yes ]
    General mortality (for any causes).

  • Side effects [ Time Frame: From the third to the 14th day after subarachnoid hemorrhage. ] [ Designated as safety issue: Yes ]
    Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.

  • Time to discharge [ Time Frame: From the third day after subarachnoid hemorrhage to discharge. ] [ Designated as safety issue: No ]
    Time to discharge (period of hospital stay).

  • Rankin Scale [ Time Frame: At discharge from the hospital. ] [ Designated as safety issue: Yes ]
    Modified Rankin scale at discharge.


Estimated Enrollment: 18
Study Start Date: March 2010
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Viagra

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01091870

Contacts
Contact: André Cerutti Franciscatto, MD +55 51 99653833 andre@franciscatto.com
Contact: Sílvia Brustolin, Doctor +55 51 82210024 silviabrustolin@hotmail.com

Locations
Brazil
Hospital de Clínicas de Porto Alegre Recruiting
Porto Alegre, Rio Grande do Sul, Brazil, 90035903
Contact: André Cerutti Franciscatto, MD    +55 51 99653833    andre@franciscatto.com   
Contact: Sílvia Brustolin, DR    +55 51 82210024    silviabrustolin@hotmail.com   
Principal Investigator: Marco Antônio Stefani, MD, DR         
Principal Investigator: André Cerutti Franciscatto, MD         
Sub-Investigator: Ápio Martins Antunes, MD, DR         
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: André Cerutti Franciscatto, Hospital de Clínicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01091870     History of Changes
Other Study ID Numbers: SIPCEVA, 09453
Study First Received: March 17, 2010
Last Updated: March 22, 2010
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Aneurysm
Vasospasm
sildenafil
Viagra

Additional relevant MeSH terms:
Intracranial Aneurysm
Aneurysm
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
Rupture
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathologic Processes
Intracranial Hemorrhages
Wounds and Injuries
Citric Acid
Sildenafil
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Cardiovascular Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on April 16, 2014