Aneurysmal Subarachnoid HemorrhageNCT00487461
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
A study testing Simvastatin 40 mg and Simvastatin 80 mg in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by University of Illinois Chicago at 1 site in United States.
Trial summary
The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
- What is being tested?
- Simvastatin 40 mg and Simvastatin 80 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Jun 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-85 years old inclusive
- Subarachnoid hemorrhage diagnosed by CT on admission
- Randomizable within 732 hours of subarachnoid hemorrhage
- Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
- Surgical or endovascular obliteration
- Able to obtain written informed consent from patient or surrogate
Who cannot join
- Pregnancy, as confirmed by routine urine test on admission
- Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
- On Statins, niacin, or fibrate therapy within 30 days of presentation
- Any vasospasm on the initial diagnostic angiogram
- Glasgow Coma Scale 5 or less at the time of randomization
- History of liver disease or active liver disease
- Hypersensitivity to statins
- Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Illinois at Chicago, Dept of Neurosurgery
Chicago, Illinois, 60612
About this study
Official title: Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.
Read the detailed description
Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.
- Being tested
- Simvastatin 40 mg, Placebo, Simvastatin 80 mg
- Keywords
- SAH, Vasospasm
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin 40 mgDrug
Also called Zocor
Comparing two doses of Simvastatin to placebo
PlaceboDrug
Also called dummy pill, sugar pill
Placebo tablet
Simvastatin 80 mgDrug
Also called Zocor
Comparing two doses of Simvastatin to placebo
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Placebo tablet Receives: Drug: Placebo |
| Study Group #1 | Experimental | Simvastatin 40 mg Receives: Drug: Simvastatin 40 mg |
| Study Group #2 | Experimental | Simvastatin 80 mg Receives: Drug: Simvastatin 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH
Measured: 21 days
Secondary outcomes (1)
To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up
Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2007 (estimated)
- Study startMay 2007
- Primary completionFeb 2009
- Study completionJun 2009
Why it stopped: Study PI left the institution and study was stopped at that time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Alaraj, University of Illinois Chicago
- Investigators
- Ben Z. Roitberg, MD, Principal investigator, Assnt Prof. Univ. of Illinois at Chicago, Dept of NeurosurgeryAli Alaraj, MD, Principal investigator, Clinical Fellow Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00487461
- Sponsor's protocol ID
- 2005-0857
- Status last verified
- Oct 2015
- First submitted
- 15 Jun 2007
- Last updated
- 25 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00487461
- Acronym / sponsor ID
- 2005-0857
- Keywords
- SAH, Vasospasm
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study PI left the institution and study was stopped at that time.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 18 Jun 2007 (estimated)
- Results
- Posted 25 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.
Detailed description
Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: PlaceboPlacebo tablet |
| Study Group #1 | Experimental | Drug: Simvastatin 40 mgSimvastatin 40 mg |
| Study Group #2 | Experimental | Drug: Simvastatin 80 mgSimvastatin 80 mg |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-85 years old inclusive
- Subarachnoid hemorrhage diagnosed by CT on admission
- Randomizable within 732 hours of subarachnoid hemorrhage
- Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
- Surgical or endovascular obliteration
Key exclusion criteria (8 listed)
- Pregnancy, as confirmed by routine urine test on admission
- Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
- On Statins, niacin, or fibrate therapy within 30 days of presentation
- Any vasospasm on the initial diagnostic angiogram
- Glasgow Coma Scale 5 or less at the time of randomization
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 |
|---|---|---|
| Simvastatin 40 mgAlso: ZocorComparing two doses of Simvastatin to placebo | Drug | Study Group #1 |
| PlaceboAlso: dummy pill, sugar pillPlacebo tablet | Drug | Control Group |
| Simvastatin 80 mgAlso: ZocorComparing two doses of Simvastatin to placebo | Drug | Study Group #2 |
Primary outcome
To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH
Time frame: 21 days
1 secondary outcome
To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Ben Z. Roitberg, MD principal investigator
Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery
Ali Alaraj, MD principal investigator
Clinical Fellow Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin 40 mg and Simvastatin 80 mg in people with Aneurysmal Subarachnoid Hemorrhage and Cerebral Vasospasm, run by University of Illinois Chicago at 1 site in United States.
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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 25 Nov 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 United States. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH (time frame: 21 days). 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 Nov 2015.