Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).

• Status: Unknown status
• Trial end date: 2019-12-01
• Target enrollment: 0
• Participant gender: All

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. 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Southampton NHS Foundation Trust
• Treatments: Aspirin

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

• 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