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Evaluating oral peri-operative acetylsalicylic acid in subjects undergoing endovascular coiling-only of unruptured brain aneurysms
EU CTIS ID: 2024-517674-23-00
What this study is testing
To demonstrate lower incidence of stroke in acetylsalicylic acid (ASA) vs placebo arms after coiling.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age ≥ 18 years
- 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
You likely can't join if
- 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
- Planned treatment of more than one aneurysm in the same procedure.
- 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.
- Subjects who are under legal protection measure (curatelle/tutelle)
- Planned treatment for 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
See the full eligibility criteria
- Age ≥ 18 years
- 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
- 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
- Planned treatment of more than one aneurysm in the same procedure.
- 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.
- Subjects who are under legal protection measure (curatelle/tutelle)
- Planned treatment for 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, 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.
- Unable to take the study drug orally for any reason
- Subjects already taking single or dual antiplatelet, warfarin, or any of the non-Vitamin K antagonist oral anticoagulants
- Subjects unable to undergo MRI imaging for any reason (e.g., severe claustrophobia or presence of metals)
- 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.
- Pregnancy or breastfeeding
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.