ACETYLSALICYLIC ACID for Unruptured intracranial aneurysm

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment\n- Functionally independent at baseline (modified Rankin scale <3)\n- Informed consent and availability of the subject for the entire study period"}

Exclusion criteria

• {"criterion_text":"- 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\n- Planned treatment of more than one aneurysm in the same procedure.\n- Participation in another clinical trial of an investigational drug, device or procedure if the subject received the trial drug, device or procedure in the preceding 30 days from the anticipated coiling date.\n- Subjects who are under legal protection measure (curatelle/tutelle)\n- Planned treatment for dissecting or mycotic brain aneurysm\n- Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization\n- Allergy, hypersensitivity, or contraindication to ASA or their risk markers as: a) A history of asthma caused by salicylates or substances with similar effect. b) Severe hepatic or renal impairment. c) Severe cardiac insufficiency. d) Patients already receiving therapeutic heparin treatment. e) Patients with cross-hypersensitivity to other NSAIDs (indomethacin, phenylbutazone, ibuprofen, diflunisal). e) Methotrexate in doses higher than 15 mg/week.\n- Unable to take the study drug orally for any reason\n- Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants\n- Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals)\n- Any other medical condition that the site investigator deems would put the subject at excessive risk by participation in the study (e.g. active bleeding, symptomatic peptic ulcer disease, liver or kidney failure, thrombocytopenia or coagulopathy) or an expected life expectancy less than one year, or that would result in an inability to collect radiological outcomes and clinical outcomes at 90 days.\n- Pregnancy or breastfeeding"}

Primary endpoints

• {"endpoint_text":"- Incidence of embolic strokes (clinically or on DWI-MRI) in ASA vs placebo on Day 5 of the study (12-48 hours following coiling procedure).","definition_or_measurement_approach":"Occurrence of embolic strokes identified clinically or by diffusion-weighted MRI performed on Day 5 (12-48 hours post-coiling)."}

Secondary endpoints

• {"endpoint_text":"- Clinical thromboembolic events by Day 90 following coiling","definition_or_measurement_approach":"Assessment of clinically evident thromboembolic events occurring within 90 days after coiling."}
• {"endpoint_text":"- Count of new DWI lesions on post-coiling MRI","definition_or_measurement_approach":"Number of new diffusion-weighted imaging lesions detected on MRI after the coiling procedure."}
• {"endpoint_text":"- Frequency of large (> 10 cc volume) strokes on DWI MR","definition_or_measurement_approach":"Frequency/count of diffusion-weighted MRI lesions with volume >10 cc."}
• {"endpoint_text":"- Incidence of cognitive decline from baseline to 90-day follow-up","definition_or_measurement_approach":"Change in cognitive assessments from baseline to Day 90, reporting incidence of decline."}
• {"endpoint_text":"- Incidence of visible thrombus formation during the coiling procedure","definition_or_measurement_approach":"Recording whether visible thrombus formation was observed during the endovascular coiling procedure."}
• {"endpoint_text":"- Total volume of embolic strokes on DWI MR imaging","definition_or_measurement_approach":"Summed volume of embolic lesions measured on diffusion-weighted MRI."}
• {"endpoint_text":"- Death rate within 90 days following coiling in the ASA vs. placebo group","definition_or_measurement_approach":"All-cause mortality within 90 days post-procedure, compared between arms."}
• {"endpoint_text":"- Any peri-operative hemorrhagic complication (intracranial hemorrhage, retroperitoneal hematoma, upper or lower gastrointestinal bleeding, or any bleeding stratified as major according to TIMI (Thrombolysis in Myocardial Infarction))","definition_or_measurement_approach":"Recording of peri-operative hemorrhagic events, including intracranial, retroperitoneal, GI bleeding, or TIMI-major bleeding."}
• {"endpoint_text":"- To assess whether treatment with ASA is associated with better short- and long-term cognitive and neuropsychiatric outcomes up to 1-year post-procedure","definition_or_measurement_approach":"Cognitive and neuropsychiatric outcome measures assessed up to 1 year post-procedure (exploratory follow-up assessments)."}
• {"endpoint_text":"- To examine these outcomes in patients with different burdens of iatrogenic brain infarcts, and assess how any treatment effects of ASA are mediated by this infarct burden","definition_or_measurement_approach":"Subgroup analyses by burden of iatrogenic brain infarcts to assess mediation of treatment effects."}
• {"endpoint_text":"- To assess whether ASA is associated with better cognitive-related activities of daily living (ADLs) and health-related quality of life up to 1-year post-procedure","definition_or_measurement_approach":"Assessment of ADLs and health-related quality of life measures up to 1 year after procedure."}

France

Earliest CTIS Part Ii Submission Date

09-10-2024

Latest Decision Or Authorization Date

17-03-2026

Processing Time Days

524

Number Of Sites

7

Number Of Participants

200

Primary sponsor

Full Name

University Of Calgary

Organisation Type

Educational Institution

Country Of Registered Address

Canada