Subarachnoid HemorrhagePhase 2SIPCEVANCT01091870
Sildenafil for Prevention of Cerebral Vasospasm
A Phase 2 study testing Sildenafil Citrate, 25 mg, 3 times a day. and Sildenafil Citrate 50 mg, 3 times a day in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Rupture of Intracranial Aneurysm
- What is being tested?
- Sildenafil Citrate, 25 mg, 3 times a day. and Sildenafil Citrate 50 mg, 3 times a day
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2010to Dec 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- Previous use of drugs witch can interact with sildenafil (specially nitrates).
- Pregnancy.
- Known hypersensibility to Sildenafil.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
About this study
Official title: Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial
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.
- Being tested
- Placebo, Sildenafil Citrate, 25 mg, 3 times a day., Sildenafil Citrate 50 mg, 3 times a day
- Keywords
- Aneurysm, Vasospasm, sildenafil, Viagra
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
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.Drug
Also called Viagra
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 dayDrug
Also called Viagra
Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
| Study group | Role | What they receive |
|---|---|---|
| Placebo: soluble blue pigment | Placebo comparator | Soluble blue pigment for placebo controlling. Receives: Drug: Placebo |
| Sildenafil, 75mg daily | Experimental | Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage. Receives: 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. Receives: Drug: Sildenafil Citrate 50 mg, 3 times a day |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From third to 14th day post subarachnoid hemorrhage
Secondary outcomes (5)
Transcranial Ecodoppler
Signs of vasospasm in in transcranial ecodoppler.
Measured: From the third to the 14th day after subarachnoid hemorrhage
Mortality
General mortality (for any causes).
Measured: From the third to the 14th day before subarachnoid hemorrhage.
Side effects
Drug side effect: hypotension, visual blurring, nasal congestion, angina pectoris, asthma crisis, AV block, digestive bleeding, and priapism.
Measured: From the third to the 14th day after subarachnoid hemorrhage.
Time to discharge
Time to discharge (period of hospital stay).
Measured: From the third day after subarachnoid hemorrhage to discharge.
Rankin Scale
Modified Rankin scale at discharge.
Measured: At discharge from the hospital.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2012 (estimated)
Why it stopped: Absence of inclusion criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- André Cerutti Franciscatto, MD, Principal investigator, Hospital de Clinicas de Porto AlegreMarco Antônio Stefani, DR, Study director, Hospital de Clinicas de Porto AlegreÁpio Martins Antunes, DR, Study chair, Hospital de Clinicas de Porto AlegreThiago Torres de Ávila, MD, Study chair, Hospital de Clinicas de Porto AlegreMateus Lasta Beck, MD, Study chair, Hospital de Clinicas de Porto AlegreMateus Franzói, MD, Study chair, Hospital de Clinicas de Porto AlegreAtahualpa Caue Strapasson, MD, Study chair, Hospital de Clinicas de Porto AlegreSílvia Brustolin, DR, Study chair, Hospital de Clinicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091870
- Sponsor's protocol ID
- SIPCEVA
- Other IDs
- 09453
- Acronym
- SIPCEVA
- Status last verified
- Mar 2015
- First submitted
- 17 Mar 2010
- Last updated
- 25 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sildenafil for Prevention of Cerebral Vasospasm Secondary to Subarachnoid Haemorrhage - Phase II Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01091870
- Acronym / sponsor ID
- SIPCEVA / SIPCEVA
- Keywords
- Aneurysm, Vasospasm, sildenafil, Viagra
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Absence of inclusion criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Dec 2012 (estimated)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo: soluble blue pigment | Placebo comparator | Drug: PlaceboSoluble blue pigment for placebo controlling. |
| Sildenafil, 75mg daily | Experimental | Drug: Sildenafil Citrate, 25 mg, 3 times a day.Sildenafil citrate, 75 mg daily divided in 3 doses. From third to 14th day after subarachnoid hemorrhage. |
| Sildenafil, 150 mg daily | Experimental | Drug: Sildenafil Citrate 50 mg, 3 times a daySildenafil citrate, 150 mg daily divided in 3 doses from third to 14th day after subarachnoid hemorrhage. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboSoluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage. | Drug | Placebo: soluble blue pigment |
| Sildenafil Citrate, 25 mg, 3 times a day.Also: ViagraSildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage. | Drug | Sildenafil, 75mg daily |
| Sildenafil Citrate 50 mg, 3 times a dayAlso: ViagraSildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage. | Drug | Sildenafil, 150 mg daily |
Primary outcome
New neurological Deficit
Time frame: From third to 14th day post subarachnoid hemorrhage
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.
5 secondary outcomes
Transcranial Ecodoppler
Time frame: From the third to the 14th day after subarachnoid hemorrhage
Mortality
Time frame: From the third to the 14th day before subarachnoid hemorrhage.
Side effects
Time frame: From the third to the 14th day after subarachnoid hemorrhage.
Time to discharge
Time frame: From the third day after subarachnoid hemorrhage to discharge.
Rankin Scale
Time frame: At discharge from the hospital.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2015.
- Official Site of Hospital de Clínicas de Porto AlegreLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
André Cerutti Franciscatto, MD principal investigator
Hospital de Clinicas de Porto Alegre
Marco Antônio Stefani, DR study director
Hospital de Clinicas de Porto Alegre
Ápio Martins Antunes, DR study chair
Hospital de Clinicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil Citrate, 25 mg, 3 times a day. and Sildenafil Citrate 50 mg, 3 times a day in people with Subarachnoid Hemorrhage and Cerebral Vasospasm, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 25 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New neurological Deficit (time frame: From third to 14th day post subarachnoid hemorrhage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2015.