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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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. completion date
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


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
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