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Clinical Trials in Canada / NCT04192955
Recruiting Phase 3

Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms

NCT04192955 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2020-07-14
Last updated
2026-09-02

Condition(s) studied

Unruptured Cerebral Aneurysm

Investigational drug(s) / intervention(s)

Acetyl Salicylate

Acetyl Salicylate: Tablets

Study summary

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)

Trial sites (9)

FacilityCityRegionStatus
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 Tours Centre-Val de Loire Recruiting

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Other trials for the same condition

Official registry record

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.

View NCT04192955 on ClinicalTrials.gov ↗ ← All trials in Canada