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RECRUITING
NCT04192955
PHASE3

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

Sponsor: University of Calgary

View on ClinicalTrials.gov

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

Interventions

DRUG

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