Subarachnoid HaemorrhagePhase 3STASHNCT00731627
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
A Phase 3 study testing simvastatin in people with Subarachnoid Haemorrhage, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites in United States.
Trial summary
Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Subarachnoid Haemorrhage
- What is being tested?
- simvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 803 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Feb 2014
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients (age 18 - 65 yr) in which the admitting neurosurgeon has confirmatory evidence of an aneurysm, either by CT angiography, MR angiography or DSA.
- Any clinical grade accepted provided a reasonable prospect of survival.
- Delay to randomisation and initiation of trial medication from the time of the presenting ictus does not exceed 96 hours.
Who cannot join
- Unsalvageable patients:Fixed and dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy.
- Already taking statin therapy.
- Those taking Warfarin - type drugs.
- Pregnancy.
- Known renal or hepatic impairment
- Suspected or known additional disease process, which threatens life expectancy (e.g.malignancy).
- Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to 6 month follow up.
- Those already taking amiodarone, verapamil or potent CYP3A4 inhibitors.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dept of Neurological Surgery, University of Florida
Gainesville, Florida, 32610
Mayo Clinic
Jacksonville, Florida, 32224
About this study
Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH.
The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).
- Conditions
- Subarachnoid Haemorrhage
- Being tested
- placebo, simvastatin
- Keywords
- intracranial aneurysm
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
Also called placebo tablet
one tablet a day for up to 21 days
simvastatinDrug
Also called ritechol
simvastatin 40mg once a day for a maximum of 21 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | placebo Receives: Drug: placebo |
| 11 | Active comparator | simvastatin Receives: Drug: simvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Rankin Disability Score (mRS) at 6 months
Measured: 6-12 months
Secondary outcomes (5)
Need and intensity of delayed ischaemic deficit rescue therapy
Measured: 1-3 months
Incidence and duration of delayed ischaemic deficits
Measured: 1-3 months
Incidence and severity of sepsis
Measured: 1-3 months
Length of intensive care and total acute hospital stay
Measured: 1-3 months
Discharge destination
Measured: 1-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HaemorrhageStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 803 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Principal investigator, Mr PJ Kirkpatrick, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731627
- Sponsor's protocol ID
- 2006-000277-30
- Other IDs
- ISRCTN75948817
- Acronym
- STASH
- Status last verified
- Jun 2014
- First submitted
- 7 Aug 2008
- Last updated
- 25 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Budohoski KP, Czosnyka M, Kirkpatrick PJ. The Role of Monitoring Cerebral Autoregulation After Subarachnoid Hemorrhage. Neurosurgery. 2015 Aug;62 Suppl 1:180-4. doi: 10.1227/NEU.0000000000000808. No abstract available.
PubMed 26181941
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00731627
- Acronym / sponsor ID
- STASH / 2006-000277-30
- Conditions
- Subarachnoid Haemorrhage
- Keywords
- intracranial aneurysm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 803 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- Jan 2007
- Primary completion
- Sep 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 11 Aug 2008 (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.
Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH.
The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Drug: placeboplacebo |
| 11 | Active comparator | Drug: simvastatinsimvastatin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients (age 18 - 65 yr) in which the admitting neurosurgeon has confirmatory evidence of an aneurysm, either by CT angiography, MR angiography or DSA.
- Any clinical grade accepted provided a reasonable prospect of survival.
- Delay to randomisation and initiation of trial medication from the time of the presenting ictus does not exceed 96 hours.
Key exclusion criteria (8 listed)
- Unsalvageable patients:Fixed and dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy.
- Already taking statin therapy.
- Those taking Warfarin - type drugs.
- Pregnancy.
- Known renal or hepatic impairment
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 |
|---|---|---|
| placeboAlso: placebo tabletone tablet a day for up to 21 days | Drug | 1 |
| simvastatinAlso: ritecholsimvastatin 40mg once a day for a maximum of 21 days | Drug | 11 |
Primary outcome
Modified Rankin Disability Score (mRS) at 6 months
Time frame: 6-12 months
5 secondary outcomes
Need and intensity of delayed ischaemic deficit rescue therapy
Time frame: 1-3 months
Incidence and duration of delayed ischaemic deficits
Time frame: 1-3 months
Incidence and severity of sepsis
Time frame: 1-3 months
Length of intensive care and total acute hospital stay
Time frame: 1-3 months
Discharge destination
Time frame: 1-3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2014.
- Derived from this study: PubMed 26181941Budohoski KP, Czosnyka M, Kirkpatrick PJ. The Role of Monitoring Cerebral Autoregulation After Subarachnoid Hemorrhage. Neurosurgery. 2015 Aug;62 Suppl 1:180-4. doi: 10.1227/NEU.0000000000000808. No abstract available.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing simvastatin in people with Subarachnoid Haemorrhage, run by Cambridge University Hospitals NHS Foundation Trust at 2 sites 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 3 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: finished, as of the sponsor's last update on 25 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Modified Rankin Disability Score (mRS) at 6 months (time frame: 6-12 months). 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 NCT00731627, 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 25 Jun 2014.