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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Calgary

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Acetyl Salicylate

    Drug

    Tablets

Treatment groups

440 Participants
are divided into 2 treatment groups
Group A: ActiveActive comparator 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinical or silent stroke

Incidence of embolic strokes (clinically or on DWI-MRI)

Time frame
within 2-4 days of completion of the coiling procedure

Secondary outcomes

1

Symptomatic stroke

Clinical thromboembolic events

Time frame
Day 90 following coiling.
2

Death rate

Time frame
within 90 days following coiling
3

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.

Time frame
within 90 days following coiling
4

Count of new DWI lesions on post-coiling MRI

Time frame
within 2-4 days of completion of the coiling procedure

Other outcomes

Sponsors and contacts

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