Oral aspirin around the time of endovascular coiling for unruptured brain aneurysms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 3, randomized, placebo-controlled trial enrolling about 440 participants with unruptured intracranial aneurysms treated with coiling-only approaches. Participants are randomly assigned 1:1 to receive aspirin or placebo for five days surrounding the procedure, with blinded endpoint assessment. The primary outcome is the occurrence of a clinical or silent stroke at discharge, evaluated clinically and by MRI, with follow-up functional outcomes collected at 90 days. The study aims to determine if short-term aspirin prophylaxis reduces thromboembolic events during endovascular treatment. Eligible participants are functionally independent at baseline and suitable for coiling-only management; those requiring stents, with thromboembolic symptoms soon before randomization, or with contraindications to aspirin are excluded.

Why it matters

Who can join: the full rules

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.

Where it's running

• Foothills Medical Center
  Calgary, Alberta, Canada Recruiting
• U of Alberta
  Edmonton, Alberta, Canada Recruiting
• Dalhousie University
  Halifax, Nova Scotia, Canada Recruiting
• McMaster University
  Hamilton, Ontario, Canada Recruiting
• Toronto St Michael's Hospital
  Toronto, Ontario, Canada Recruiting
• Toronto Western Hospital
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Mohammed A Almekhlafi, MD MSc FRCPC — University of Calgary
• Study coordinator: Mohammed A Almekhlafi, MD MSc FRCPC
• Email: mohammed.almekhlafi1@ucalgary.ca
• Phone: 403-944-3458

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.