Could a 5-Day aspirin course shield the brain from Post-Coiling strokes?
NCT ID NCT04192955
First seen Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time
Summary
This phase 3 trial tests whether taking aspirin for five days around the time of brain aneurysm coiling can prevent strokes. About 440 adults with an unruptured brain aneurysm scheduled for coiling-only treatment will receive either aspirin or a placebo. Researchers will check for strokes, both silent and symptomatic, using brain scans and clinical exams before discharge, and follow up at day 90 to assess recovery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- acetylsalicylic acid (aspirin) tablets
- What this could lead to
- If aspirin works, it could offer a simple, low-cost way to prevent strokes in people undergoing coiling for unruptured brain aneurysms.
- What could go wrong
- The trial is still testing this idea, and aspirin may not reduce stroke risk or could increase bleeding complications. Results are not yet available.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
About 440 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Jul 2020
- Expected to finish
-
Jul 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment. * Functionally independent at baseline (modified Rankin scale \<3). * Informed consent and availability of the subject for the entire study period. Exclusion Criteria: 1. 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. 2. Dissecting or mycotic brain aneurysm. 3. Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization. 4. Allergy or contraindication to ASA. 5. Unable to take study drug orally for any reason. 6. Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants. 7. Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals). 8. Any other medical condition that the site investigator deems would put the subject at excessive risk by participation in the study (e.g. active bleeding, symptomatic peptic ulcer disease, liver or kidney failure, thrombocytopenia or coagulopathy) or an expected life expectancy less than one year, or that would result in an inability to collect radiological outcomes and clinical outcomes at 90 days. 9. Pregnancy or breastfeeding. 10. Prior enrollment in EVOLVE trial for another aneurysm. 11. Participation in another clinical trial of an investigational drug, device or procedure if the subject received the trial drug, device or procedure in the preceding 30 days from the anticipated coiling date.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Unruptured cerebral aneurysm are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
9 sites in 2 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Centre Hospitalier Régional Universitaire de Tours
RECRUITINGTours, Centre-Val de Loire, France
-
Dalhousie University
RECRUITINGHalifax, Nova Scotia, Canada
-
Foothills Medical Center
RECRUITINGCalgary, Alberta, T2N 2T9, Canada
-
McGill University
RECRUITINGMontreal, Quebec, Canada
-
McMaster University
RECRUITINGHamilton, Ontario, Canada
-
Toronto St Michael's Hospital
RECRUITINGToronto, Ontario, Toronto, Canada
-
Toronto Western Hospital
RECRUITINGToronto, Ontario, Canada
-
U of Alberta
RECRUITINGEdmonton, Alberta, Canada
-
University of Saskatchewan
RECRUITINGSaskatoon, Saskatchewan, Canada
More trials for these conditions
Other studies related to the condition(s) this trial covers.