Sildenafil for Prevention of Cerebral Vasospasm

Subarachnoid Hemorrhage Clinical Trial

— SIPCEVA  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01091870
• Other study ID #: SIPCEVA
• Secondary ID: 09453
• Status: Withdrawn
• Phase: Phase 2
• First received: March 17, 2010
• Last updated: March 24, 2015
• Start date: March 2010

Study information

• Verified date: March 2015
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Hemorrhage
• Intracranial Aneurysm
• Rupture of Intracranial Aneurysm
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Transcranial Ecodoppler	Signs of vasospasm in in transcranial ecodoppler.	From the third to the 14th day after subarachnoid hemorrhage	Yes
Secondary	Mortality	General mortality (for any causes).	From the third to the 14th day before subarachnoid hemorrhage.	Yes
Secondary	Side effects	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.	Yes
Secondary	Time to discharge	Time to discharge (period of hospital stay).	From the third day after subarachnoid hemorrhage to discharge.	No
Secondary	Rankin Scale	Modified Rankin scale at discharge.	At discharge from the hospital.	Yes

External Links

•   Official Site of Hospital de Clínicas de Porto Alegre