This trial is a is a prospective, randomized (1:1) placebo-controlled, clinical trial with blinded endpoint assessment of 440 participants with unruptured brain aneurysm planned for endovascular treatment using coiling-only approach (primary coiling or using balloon-assistance but not stenting) to test if oral acetylsalicylic acid (325 mg/ day for a total of 5 days) is superior placebo in preventing clinical and silent strokes. The primary outcome is a clinical or silent stroke at the time of discharge assessed by clinical examination and MRI brain. Participants will return to the clinic or be contacted by phone for the end of study procedures on Day 90 to collect functional outcome data.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Clinical or silent stroke — within 2-4 days of completion of the coiling procedure Incidence of embolic strokes (clinically or on DWI-MRI)
Trial sites (9)
Facility
City
Region
Status
Foothills Medical Center
Calgary
Alberta
Recruiting
U of Alberta
Edmonton
Alberta
Recruiting
Dalhousie University
Halifax
Nova Scotia
Recruiting
McMaster University
Hamilton
Ontario
Recruiting
Toronto St Michael's Hospital
Toronto
Ontario
Recruiting
Toronto Western Hospital
Toronto
Ontario
Recruiting
McGill University
Montreal
Quebec
Recruiting
University of Saskatchewan
Saskatoon
Saskatchewan
Recruiting
Centre Hospitalier Régional Universitaire de Tours
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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