Subjects undergoing elective endovascular coiling-only (primary or balloon-assisted) repair of unruptured brain aneurysms. MedDRA version: 20.1 Level: LLT Classification code 10002334 Term: Aneurysm cerebral (unruptured) System Organ Class: 100000004852
Conditions
Interventions
Trade Name: SALOSPIR
Product Name: acetylsalicylic acid
Pharmaceutical Form: Capsule
INN or Proposed INN: Acetylsalicylic acid
CAS Number: 69-72-7
Concentration unit: mg milligram(s)
Concentration typ
Sponsors
University of Calgary
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age = 18 years on the day of enrolment. 2. Unruptured intracranial aneurysm suitable for coiling-only (primary coiling or balloon-assisted) as a primary treatment. 3. Functionally independent at baseline (modified Rankin scale =65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria
Exclusion criteria: 1. 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. 2. Planned treatment for dissecting or mycotic brain aneurysm. 3. Any ongoing ischemic symptoms such as transient ischemic attacks, minor strokes, or stroke-in-evolution within 2 weeks before randomization. 4. Allergy or contraindication to ASA . 5. Unable to take the study drug orally for any reason. 6. Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants. 7. Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals). 8. 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. 9. Pregnancy or breastfeeding. 10. Prior enrollment in EVOLVE trial for another aneurysm. 11. 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. 12. Subjects who are under legal protection measure (curatelle/tutelle).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. 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).;Secondary Objective: 1. Clinical thromboembolic events by Day 90 following coiling. 2. Count of new DWI lesions on post-coiling MRI. 3. Frequency of large (> 10 cc volume) strokes on DWI MR. 4. Incidence of cognitive decline from baseline to 90-day follow-up. 5. Incidence of visible thrombus formation during the coiling procedure. 6. Total volume of embolic strokes on DWI MR imaging 7. Death rate within 90 days following coiling in the ASA vs. placebo group. 8.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) trial in the ASA vs. placebo group.;Primary end point(s): 1. Incidence of embolic strokes (clinically or on DWI-MRI);Timepoint(s) of evaluation of this end point: 1. 12-48 hours following coiling procedure | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Clinical thromboembolic events by Day 90 following coiling. 2. Count of new DWI lesions on post-coiling MRI. 3. Frequency of large (> 10 cc volume) strokes on DWI MR. 4. Incidence of cognitive decline from baseline to 90-day follow-up. 5. Incidence of visible thrombus formation during the coiling procedure. 6. Total volume of embolic strokes on DWI MR imaging 7. Death rate within 90 days following coiling in the ASA vs. placebo group. 8. 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) trial in the ASA vs. placebo group.;Timepoint(s) of evaluation of this end point: 1. 90 days following coiling procedure 2. 12-48 hours following coiling procedure 3. 12-48 hours following coiling procedure 4. 90 days following coiling procedure 5. During the coiling procedure 6. 12-48 hours following coiling procedure 7. 90 days following coiling procedure 8. 90 days following coiling procedure | — |
Countries
France
Contacts
Public ContactClinical Trials coordinator
University Hospital of Tours
Outcome results
None listed