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Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms
Sponsor: University of Calgary
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.
Official title: Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms(EVOLVE): A Phase 3 Multicenter Randomized Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
440
Start Date
2020-07-14
Completion Date
2027-07
Last Updated
2026-09-02
Healthy Volunteers
No
Conditions
Interventions
Acetyl Salicylate
Tablets
Locations (9)
Foothills Medical Center
Calgary, Alberta, Canada
U of Alberta
Edmonton, Alberta, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
McMaster University
Hamilton, Ontario, Canada
Toronto St Michael's Hospital
Toronto, Ontario, Canada
Toronto Western Hospital
Toronto, Ontario, Canada
McGill University
Montreal, Quebec, Canada
University of Saskatchewan
Saskatoon, Saskatchewan, Canada
Centre Hospitalier Régional Universitaire de Tours
Tours, Centre-Val de Loire, France