RecruitingPhase 3NCT04192955

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

Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms(EVOLVE): A Phase 3 Multicenter Randomized Study


Sponsor

University of Calgary

Enrollment

440 participants

Start Date

Jul 14, 2020

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Acetyl Salicylate for people with unruptured cerebral aneurysm. The study is currently recruiting participants at 9 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAcetyl 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

View Full Details on ClinicalTrials.gov

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NCT04192955


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