NCT04192955 Evaluating Oral Peri-operative Acetylsalicylic Acid in Subjects Undergoing Endovascular Coiling-only of Unruptured Brain Aneurysms
| NCT ID | NCT04192955 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of Calgary |
| Condition | Unruptured Cerebral Aneurysm |
| Study Type | INTERVENTIONAL |
| Enrollment | 440 participants |
| Start Date | 2020-07-14 |
| Primary Completion | 2027-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 440 participants in total. It began in 2020-07-14 with a primary completion date of 2027-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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. 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. 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 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.
Contact & Investigator
Mohammed A Almekhlafi, MD MSc FRCPC
PRINCIPAL INVESTIGATOR
University of Calgary
Frequently Asked Questions
Who can join the NCT04192955 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Unruptured Cerebral Aneurysm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04192955 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 440 participants.
Is NCT04192955 currently recruiting?
Yes, NCT04192955 is actively recruiting participants. Contact the research team at mohammed.almekhlafi1@ucalgary.ca for enrollment information.
Where is the NCT04192955 trial being conducted?
This trial is being conducted at Calgary, Canada, Edmonton, Canada, Halifax, Canada, Hamilton, Canada and 5 additional locations.
Who is sponsoring the NCT04192955 clinical trial?
NCT04192955 is sponsored by University of Calgary. The principal investigator is Mohammed A Almekhlafi, MD MSc FRCPC at University of Calgary. The trial plans to enroll 440 participants.