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Nonsteroidal Anti-inflammatory Drug

Aspirin for Unruptured Brain Aneurysm (EVOLVE Trial)

Phase 3

Recruiting

Led By Mohammed A Almekhlafi

Research Sponsored by University of Calgary

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Functionally independent at baseline (modified Rankin scale <3).

Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment.

Must not have

Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants.

Planned complex aneurysm treatment including use of any device that requires post-operative antiplatelet therapy (stent-assisted coiling or flow-diverter device), or endovascular vessel sacrifice.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90 following coiling.

Awards & highlights

Pivotal Trial

Summary

This trial is testing if aspirin is better than placebo at preventing strokes in people with unruptured brain aneurysms.

Who is the study for?

This trial is for adults with unruptured brain aneurysms suitable for coiling-only treatment. They must be functionally independent and able to give consent. Excluded are those needing complex treatments, unable to take oral medication or undergo MRI, have certain medical risks like bleeding disorders, pregnant or breastfeeding women, and anyone on antiplatelet or anticoagulant therapy.

What is being tested?

The study tests if taking acetylsalicylic acid (325 mg/day for 5 days) is better than a placebo in preventing strokes after endovascular coiling of unruptured brain aneurysms. The main goal is to see if there's a stroke at discharge time by clinical exam and MRI, with follow-up functional outcome data collected on Day 90.

What are the potential side effects?

Possible side effects of acetylsalicylic acid include increased risk of bleeding, digestive issues like stomach pain or heartburn, allergic reactions, and potentially liver or kidney problems in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can do most daily activities by myself.

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I have a brain aneurysm that can be treated with coiling.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently on blood thinners.

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I am scheduled for a complex aneurysm treatment that will need blood-thinning medication afterwards.

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I have a dissecting or infected brain aneurysm.

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I am allergic to or cannot take aspirin.

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I cannot take pills by mouth.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90 following coiling.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90 following coiling.

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 following coiling. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Clinical or silent stroke

Secondary study objectives

Peri-operative hemorrhagic complication

Symptomatic stroke

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: ActiveActive Control1 Intervention

Acetylsalicylic acid (ASA) will be given orally at a dose of 324 mg to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.

Group II: ControlPlacebo Group1 Intervention

Lactose100-mg tablets to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.

0 / 7Eligibility criteria met