Subarachnoid HemorrhagePhase 1/2NCT00795288
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
A Phase 1/2 study testing Simvastatin, 80 mg/day for 21 days in people with Subarachnoid Hemorrhage, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- Simvastatin, 80 mg/day for 21 days
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Dec 2013
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18
- SAH from ruptured cerebral aneurysm within 48 hours of admission.
- Modified Fisher grade 2,3,or 4
- Planned surgical or endovascular aneurysm repair
Who cannot join
- Pregnancy
- SAH secondary to traumatic or mycotic aneurysms
- Pre-ictal statin therapy
- Contraindication to stain therapy
- WFNS grade 5
- Contraindications to MAP elevation on day 7-10
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.
Read the detailed description
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- Simvastatin, 80 mg/day for 21 days, placebo
- Keywords
- subarachnoid hemorrhage, vasospasm, cerebral blood flow, cerebral metabolism, autoregulation, statin, Vasospasm associated with Subarachnoid hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simvastatin, 80 mg/day for 21 daysDrug
Also called Simvastatin
Active treatment group
placeboDrug
Control group
| Study group | Role | What they receive |
|---|---|---|
| Simvastatin, 80 mg/day | Experimental | Simvastatin, 80 mg/day for 21 days Receives: Drug: Simvastatin, 80 mg/day for 21 days |
| Placebo | Placebo comparator | Placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Measured: 7-10 days after hemorrhage
Cerebral Autoregulation During Peak Period of Vasospasm Risk
Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.
Measured: 7-10 days after hemorrhage
Secondary outcomes (1)
Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.
Measured: 7-10 days after hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2008 (estimated)
- Study startAug 2008
- Primary completionFeb 2013
- Study completionDec 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Diringer, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00795288
- Sponsor's protocol ID
- 3857 - 54118B
- Status last verified
- Feb 2016
- First submitted
- 20 Nov 2008
- Last updated
- 21 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7.
PubMed 26721259
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00795288
- Acronym / sponsor ID
- 3857 - 54118B
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, vasospasm, cerebral blood flow, cerebral metabolism, autoregulation, statin, Vasospasm associated with Subarachnoid hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Nov 2008 (estimated)
- Results
- Posted 16 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.
Detailed description
We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simvastatin, 80 mg/day | Experimental | Drug: Simvastatin, 80 mg/day for 21 daysSimvastatin, 80 mg/day for 21 days |
| Placebo | Placebo comparator | Drug: placeboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age > 18
- SAH from ruptured cerebral aneurysm within 48 hours of admission.
- Modified Fisher grade 2,3,or 4
- Planned surgical or endovascular aneurysm repair
Key exclusion criteria (6 listed)
- Pregnancy
- SAH secondary to traumatic or mycotic aneurysms
- Pre-ictal statin therapy
- Contraindication to stain therapy
- WFNS grade 5
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, 80 mg/day for 21 daysAlso: SimvastatinActive treatment group | Drug | Simvastatin, 80 mg/day |
| placeboControl group | Drug | Placebo |
Primary outcome
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk
Time frame: 7-10 days after hemorrhage
Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Cerebral Autoregulation During Peak Period of Vasospasm Risk
Time frame: 7-10 days after hemorrhage
Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.
1 secondary outcome
Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk
Time frame: 7-10 days after hemorrhage
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 26721259Diringer MN, Dhar R, Scalfani M, Zazulia AR, Chicoine M, Powers WJ, Derdeyn CP. Effect of High-Dose Simvastatin on Cerebral Blood Flow and Static Autoregulation in Subarachnoid Hemorrhage. Neurocrit Care. 2016 Aug;25(1):56-63. doi: 10.1007/s12028-015-0233-7.
- Individual participant dataSharing planned: No
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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.
Michael Diringer, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Simvastatin, 80 mg/day for 21 days in people with Subarachnoid Hemorrhage, run by Washington University School of Medicine 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 21 Mar 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 16 Jan 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?
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk (time frame: 7-10 days after hemorrhage). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00795288, which also lists 1 linked publication.
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 21 Mar 2016.