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

NCT04192955 Phase 3 UNKNOWN

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.

Details

Lead sponsor	University of Calgary
Phase	Phase 3
Status	UNKNOWN
Enrolment	440
Start date	2020-07-14
Completion	2024-12

Conditions

• Unruptured Cerebral Aneurysm

Interventions

• Acetyl Salicylate

Primary outcomes

• Clinical or silent stroke — within 2-4 days of completion of the coiling procedure
  Incidence of embolic strokes (clinically or on DWI-MRI)

Countries

Canada, France