About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment.
Functionally independent at baseline (modified Rankin scale <3).
Informed consent and availability of the subject for the entire study period.
Disqualifiers
Planned complex aneurysm treatment including use of any device that requires post-operative antiplatelet therapy (stent-assisted coiling or flow-diverter device), or endovascular vessel sacrifice.
Dissecting or mycotic brain aneurysm.
Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization.
Allergy or contraindication to ASA.
Trial design
Parallel
Treatments tested in this trial
Acetyl Salicylate
DrugTablets
Treatment groups
Trial outcomes
Primary outcomes
Clinical or silent stroke
Incidence of embolic strokes (clinically or on DWI-MRI)
Secondary outcomes
Symptomatic stroke
Clinical thromboembolic events
Death rate
Peri-operative hemorrhagic complication
intracranial hemorrhage, retroperitoneal hematoma, upper or lower gastrointestinal bleeding, or any bleeding stratified as major according to thrombolysis in myocardial infarction (TIMI) definition.
Count of new DWI lesions on post-coiling MRI
Sponsors and contacts
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