Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).

NCT03661463 | Unknown Phase 2 DMC

• 1 other identifier: RHM NEU 0341
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intracranial Aneurysm; Inflammation

Keywords

Aspirin; Magnetic Resonance Vessel Wall Imaging

Outcome Measures

Primary Outcomes (1)

• 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.

  3 months

Study Arms (2)

Aspirin

EXPERIMENTAL

Aspirin (Acetylsalicylic Acid \[ASA\]) tablets, 300mg once a day, for 90 days.

Drug: Aspirin

No Treatment

NO INTERVENTION

No medical treatment

Interventions

Aspirin DRUG

Drug

Also known as: acetylsalicylic acid

Aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital Southampton NHS Foundation Trust: lead

Study Sites (1)

University Hospital Southampto NHS Foundation Trust

Southampton, Hampshire, SO16 6YD, United Kingdom

RECRUITING

MeSH Terms

Conditions

Intracranial Aneurysm; Inflammation

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Diederik Bulters, FRCS (SN)

  Wessex Neurological Centre, Southampton General Hospital, University Hospital Southampton NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sharon Davies-Dear

CONTACT

+44-(0)23-8120 5664; sharon.davies-dear@uhs.nhs.uk

Emily Watkins

CONTACT

+44-(0)23-8120 4862; emily.watkins@uhs.nhs.uk

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessor of radiological outcomes will be blinded to which arm of the trial patients were randomised to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 2 Parallel Arms - one with the intervention (Aspirin 300mg OD), and one with no treatment. 29 patients each arm.

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: September 7, 2018
• Study Start: October 24, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)