drugset / Trial / NCT04192955

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

NCT04192955 ↗

Phase 3 Unknown 440 enrolled University of Calgary
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2020-07-14
Primary completion
2024-09
Completion
2024-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Aspirin Small molecule 325 mg Oral

Indications