Intracranial AneurysmPhase 2UIAATNCT03661463
Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).
A Phase 2 study testing Aspirin in people with Intracranial Aneurysm and Inflammation, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Does Aspirin reduce inflammation in the walls of unruptured brain aneurysms? Brain aneurysms are balloon-like outpouchings of a blood vessel resulting from a weakness in the vessel wall. They generally cause no symptoms, but can burst and cause a bleed in the brain, resulting in death or disability. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intracranial Aneurysm, Inflammation
- What is being tested?
- Aspirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2019to Dec 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who will be eligible for inclusion in the study will:
- Have a saccular unruptured intracranial aneurysm identified on imaging (CT, MRI or DSA),
- Aneurysm ≥5mm
- Be aged 18 or over
- Male or female
- Capable of giving written informed consent
- Females of childbearing potential must have a negative pregnancy test. Patients of childbearing potential must agree to use an effective birth control method to avoid pregnancy for the duration of the study.
Who cannot join
- Participants will be ineligible for inclusion in the study if they have any of the following:-
- aneurysms smaller than 5mm in size.
- Aneurysm types of the following nature:
- Fusiform aneurysms
- Dissecting aneurysm
- Traumatic aneurysms
Show all 31Show fewer
- Cavernous aneurysms
- Thrombosed aneurysm
- MRI contraindications:
- Metallic implant
- Contrast allergy
- Claustrophobia
- Aspirin contraindications (or increased risk):
- Peptic ulceration
- Bleeding disorder
- Haemophilia
- Previous peptic ulceration
- Severe cardiac failure
- Severe hepatic dysfunction
- Severe renal failure
- Allergy to aspirin or NSAIDs
- Pregnancy
- Breastfeeding
- Alcoholism
- Steroid usage
- Severe asthma
- Gout
- Current warfarin or other anticoagulant use
- Current aspirin or clopidogrel use
- Current NSAID use more than once a month
- Planned treatment of the aneurysm within 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampto NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Rossana Dr Romani, rossana.romani@uhs.nhs.uk
About this study
Official title: A Randomised Controlled Trial of Aspirin Versus no Treatment to Reduce Aneurysm Wall Inflammation in Unruptured Intracranial Aneurysms.
Does Aspirin reduce inflammation in the walls of unruptured brain aneurysms?
Brain aneurysms are balloon-like outpouchings of a blood vessel resulting from a weakness in the vessel wall. They generally cause no symptoms, but can burst and cause a bleed in the brain, resulting in death or disability. Aneurysms occur in 1 in 30 people, but rarely burst, with 1 in 10,000 people having a brain bleed.
Read more
Ideally, aneurysms would be treated before they burst to prevent bleeding in the brain. The two ways of treating aneurysms currently are both risky and invasive, and no medications have been shown to reduce the risk of aneurysms bursting.
Aspirin is one of the most common medications, used worldwide to treat pain, fever and inflammation, and for the prevention of strokes and heart attacks. Its anti-inflammatory properties may be beneficial for patients with aneurysms. We know that the walls of burst aneurysms and aneurysms that are about to burst, are more inflamed than those that do not burst. Therefore, a drug that reduces inflammation may reduce the risk of an aneurysm bursting.
We have designed this study to test whether there is a measurable reduction in inflammation in walls of brain aneurysms.
In this study, participants known to have an aneurysm that is not planned for treatment and has not yet burst, take aspirin daily for three months, and have an MRI scan before and after to look for a reduction in inflammation.
If this study is successful it would be the first step towards developing the first medication to help treat patients with aneurysms, representing a huge advance for the 2.1 million people in the UK with this condition.
Read the detailed description
The Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT) is a single centre, randomised, single blind, open label trial of 300mg aspirin daily versus no treatment for 3 months. 58 patients with an intracranial aneurysm diagnosed on imaging will be recruited - potential participants will be approached by their consultant neurosurgeon or a member of their direct clinical care team.
Patient interviews will take place at Wessex Neurological Centre to coincide wherever possible with standard appointments. Participants will be screened for eligibility and consented during this interview. Following consent, baseline data will be taken to include participants' baseline characteristics, other medications, and comorbidities.
The patients will then undergo a baseline MRI including VWI imaging, and then be randomised to either the 'aspirin 300mg daily' or 'no treatment' arms.
All participants will then be called by a member of the trial team between days 7 and 21 after being commenced in either arm of the trial, to review any issues with taking the medication if they are on that arm, whether they are using their drug diary, and to check for any adverse reactions or events.
Following three months of their allocated treatment, patients will undergo a second, identical MRI scan, to assess whether there is any reduction in the inflammation in the vessel walls of the aneurysms. Patients will be reviewed at this time with their drug dairy, for drug reconciliation and recording of any adverse events. This will be the end of their participation in the trial.
The study topic and design was discussed at a meeting to set research priorities advertised via the Wessex Subarachnoid Haemorrhage group that was convened by a consultant neurosurgeon and a subarachnoid haemorrhage specialist nurse with patients with unruptured and ruptured aneurysms and their carers. At this meeting the investigators clearly identified that it would be beneficial for more research into medical treatments for unruptured aneurysms and felt that with the evidence that the group would be happy to undergo the main two items required for participation in the study - treatment with aspirin and increased scanning frequency and were very supportive of the study design. Indeed the group saw the additional scanning as a strong attraction to participating in the study.
- Conditions
- Intracranial Aneurysm, Inflammation
- Being tested
- Aspirin
- Keywords
- Aspirin, Magnetic Resonance Vessel Wall Imaging
- Medical subject headings
- Intracranial Aneurysm, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AspirinDrug
Also called acetylsalicylic acid
Drug
| Study group | Role | What they receive |
|---|---|---|
| Aspirin | Experimental | Aspirin (Acetylsalicylic Acid [ASA]) tablets, 300mg once a day, for 90 days. Receives: Drug: Aspirin |
| No Treatment | No intervention | No medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
A reduction in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI).
A reduction in aneurysm wall enhancement index of at least 20% on MRI vessel wall imaging (VWI) at the end of 3 months of aspirin 300mg daily treatment, compared to no treatment.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start24 Oct 2019
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial AneurysmStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 Parallel Arms - one with the intervention (Aspirin 300mg OD), and one with no treatment. 29 patients each arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Diederik Bulters, FRCS (SN), Principal investigator, Wessex Neurological Centre, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03661463
- Sponsor's protocol ID
- RHM NEU 0341
- Acronym
- UIAAT
- Status last verified
- Aug 2019
- First submitted
- 12 Jul 2018
- Last updated
- 28 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Aspirin Versus no Treatment to Reduce Aneurysm Wall Inflammation in Unruptured Intracranial Aneurysms.
- ClinicalTrials.gov ID
- NCT03661463
- Acronym / sponsor ID
- UIAAT / RHM NEU 0341
- Conditions
- Intracranial Aneurysm, Inflammation
- Keywords
- Aspirin, Magnetic Resonance Vessel Wall Imaging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Sep 2018 (actual)
- 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.
Does Aspirin reduce inflammation in the walls of unruptured brain aneurysms?
Brain aneurysms are balloon-like outpouchings of a blood vessel resulting from a weakness in the vessel wall. They generally cause no symptoms, but can burst and cause a bleed in the brain, resulting in death or disability. Aneurysms occur in 1 in 30 people, but rarely burst, with 1 in 10,000 people having a brain bleed.
Ideally, aneurysms would be treated before they burst to prevent bleeding in the brain. The two ways of treating aneurysms currently are both risky and invasive, and no medications have been shown to reduce the risk of aneurysms bursting.
Aspirin is one of the most common medications, used worldwide to treat pain, fever and inflammation, and for the prevention of strokes and heart attacks. Its anti-inflammatory properties may be beneficial for patients with aneurysms. We know that the walls of burst aneurysms and aneurysms that are about to burst, are more inflamed than those that do not burst. Therefore, a drug that reduces inflammation may reduce the risk of an aneurysm bursting.
We have designed this study to test whether there is a measurable reduction in inflammation in walls of brain aneurysms.
In this study, participants known to have an aneurysm that is not planned for treatment and has not yet burst, take aspirin daily for three months, and have an MRI scan before and after to look for a reduction in inflammation.
If this study is successful it would be the first step towards developing the first medication to help treat patients with aneurysms, representing a huge advance for the 2.1 million people in the UK with this condition.
Detailed description
The Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT) is a single centre, randomised, single blind, open label trial of 300mg aspirin daily versus no treatment for 3 months. 58 patients with an intracranial aneurysm diagnosed on imaging will be recruited - potential participants will be approached by their consultant neurosurgeon or a member of their direct clinical care team.
Patient interviews will take place at Wessex Neurological Centre to coincide wherever possible with standard appointments. Participants will be screened for eligibility and consented during this interview. Following consent, baseline data will be taken to include participants' baseline characteristics, other medications, and comorbidities.
The patients will then undergo a baseline MRI including VWI imaging, and then be randomised to either the 'aspirin 300mg daily' or 'no treatment' arms.
All participants will then be called by a member of the trial team between days 7 and 21 after being commenced in either arm of the trial, to review any issues with taking the medication if they are on that arm, whether they are using their drug diary, and to check for any adverse reactions or events.
Following three months of their allocated treatment, patients will undergo a second, identical MRI scan, to assess whether there is any reduction in the inflammation in the vessel walls of the aneurysms. Patients will be reviewed at this time with their drug dairy, for drug reconciliation and recording of any adverse events. This will be the end of their participation in the trial.
The study topic and design was discussed at a meeting to set research priorities advertised via the Wessex Subarachnoid Haemorrhage group that was convened by a consultant neurosurgeon and a subarachnoid haemorrhage specialist nurse with patients with unruptured and ruptured aneurysms and their carers. At this meeting the investigators clearly identified that it would be beneficial for more research into medical treatments for unruptured aneurysms and felt that with the evidence that the group would be happy to undergo the main two items required for participation in the study - treatment with aspirin and increased scanning frequency and were very supportive of the study design. Indeed the group saw the additional scanning as a strong attraction to participating in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 2 Parallel Arms - one with the intervention (Aspirin 300mg OD), and one with no treatment. 29 patients each arm.
| Arm | Type | Receives |
|---|---|---|
| Aspirin | Experimental | Drug: AspirinAspirin (Acetylsalicylic Acid [ASA]) tablets, 300mg once a day, for 90 days. |
| No Treatment | No intervention | –No medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Have a saccular unruptured intracranial aneurysm identified on imaging (CT, MRI or DSA),
- Aneurysm ≥5mm
- Be aged 18 or over
- Male or female
- Capable of giving written informed consent
Key exclusion criteria (31 listed)
- Participants will be ineligible for inclusion in the study if they have any of the following:-
- aneurysms smaller than 5mm in size.
- Aneurysm types of the following nature:
- MRI contraindications:
- Aspirin contraindications (or increased risk):
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 |
|---|---|---|
| AspirinAlso: acetylsalicylic acidDrug | Drug | Aspirin |
Primary outcome
A reduction in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI).
Time frame: 3 months
A reduction in aneurysm wall enhancement index of at least 20% on MRI vessel wall imaging (VWI) at the end of 3 months of aspirin 300mg daily treatment, compared to no treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2019.
- 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.
Diederik Bulters, FRCS (SN) principal investigator
Wessex Neurological Centre, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust
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 Aspirin in people with Intracranial Aneurysm and Inflammation, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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 7 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 28 Oct 2019. 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 Kingdom. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sharon Davies-Dear (+44-(0)23-8120 5664, sharon.davies-dear@uhs.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A reduction in aneurysm wall inflammation as measured by MRI vessel wall imaging (VWI). (time frame: 3 months). 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 28 Oct 2019.