Recruiting
Phase 3

Acetylsalicylic Acid

Sponsor:

University of Calgary

Code:

NCT04192955

Conditions

Unruptured Cerebral Aneurysm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Acetyl Salicylate

Study Details

Brief 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.

Conditions

Unruptured Cerebral Aneurysm

Study ID

NCT04192955

Start date

Jul 14, 2020

Status verified date

Aug, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

440 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Active

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.

placebo comparator: Control

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.

Interventions

Acetyl Salicylate

Tablets

Primary outcome measure

  • Clinical or silent stroke [ Time Frame: within 2-4 days of completion of the coiling procedure ]

Central Contacts and Locations

Central contacts

Mohammed A Almekhlafi, MD MSc FRCPC

403-944-3458mohammed.almekhlafi1@ucalgary.ca

Karla Ryckborst, RN BN CCRP

karla.ryckborst@albertahealthservices.ca

Locations

Foothills Medical Center

Recruiting

Calgary, Alberta, Canada, T2N 2T9

Contacts

U of Alberta

Recruiting

Edmonton, Alberta, Canada

Dalhousie University

Recruiting

Halifax, Nova Scotia, Canada

McMaster University

Recruiting

Hamilton, Ontario, Canada

Toronto St Michael's Hospital

Recruiting

Toronto, Ontario, Canada, Toronto

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada

McGill University

Recruiting

Montreal, Quebec, Canada

University of Saskatchewan

Recruiting

Saskatoon, Saskatchewan, Canada

More Information

Sponsor

University of Calgary

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Calgary on 2026-09-02.