Sildenafil for Prevention of Cerebral Vasospasm

NCT01091870 | Withdrawn Phase 2 DMC

• 2 other identifiers: SIPCEVA09453
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Subarachnoid Hemorrhage; Cerebral Vasospasm; Rupture of Intracranial Aneurysm

Keywords

Aneurysm; Vasospasm; sildenafil; Viagra

Outcome Measures

Primary Outcomes (1)

• 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.

  From third to 14th day post subarachnoid hemorrhage

Secondary Outcomes (5)

• Transcranial Ecodoppler

  From the third to the 14th day after subarachnoid hemorrhage

• Mortality

  From the third to the 14th day before subarachnoid hemorrhage.

• Side effects

  From the third to the 14th day after subarachnoid hemorrhage.

• Time to discharge

  From the third day after subarachnoid hemorrhage to discharge.

• Rankin Scale

  At discharge from the hospital.

Study Arms (3)

Placebo: soluble blue pigment

PLACEBO COMPARATOR

Soluble blue pigment for placebo controlling.

Drug: Placebo

Sildenafil, 75mg daily

EXPERIMENTAL

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, 150 mg daily

EXPERIMENTAL

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

Interventions

Placebo DRUG

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

Placebo: soluble blue pigment

Sildenafil Citrate, 25 mg, 3 times a day. DRUG

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

Also known as: Viagra

Sildenafil, 75mg daily

Sildenafil Citrate 50 mg, 3 times a day DRUG

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

Also known as: Viagra

Sildenafil, 150 mg daily

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035903, Brazil

Location

Related Links

• Official Site of Hospital de Clínicas de Porto Alegre

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial; Aneurysm

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• André Cerutti Franciscatto, MD

  Hospital de Clínicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

• Marco Antônio Stefani, DR

  Hospital de Clínicas de Porto Alegre

  STUDY DIRECTOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: March 1, 2010
• Primary Completion: December 1, 2012
• Last Updated: March 25, 2015

Record last verified: 2015-03

Locations

BR (1)