Aspirin for Unruptured Brain Aneurysm
(EVOLVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether taking aspirin (acetyl salicylate) before and after a coiling procedure can help prevent strokes in people with unruptured brain aneurysms. Participants will take either aspirin or a placebo (a pill with no active medicine) to determine which is more effective. The goal is to assess if aspirin can reduce the risk of stroke, detectable by a doctor’s exam or MRI scan. This trial may suit individuals with an unruptured brain aneurysm treatable with coiling, who are functionally independent, and can take aspirin. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Is there any evidence suggesting that this treatment is likely to be safe for humans?
Research has shown that aspirin is generally safe for people with brain aneurysms. Studies have found that aspirin can help reduce the risk of an aneurysm enlarging, making it a potential option for preventing aneurysm-related issues.
In studies where participants took aspirin regularly, no major side effects were reported. The research also suggests that aspirin may lower the chance of an aneurysm bursting, which can lead to bleeding.
Overall, aspirin is well-tolerated by patients with unruptured brain aneurysms. Its long history of use has established its safety. However, like any medication, there can be risks, so consulting a doctor before starting any treatment is important.12345Why do researchers think this study treatment might be promising for brain aneurysm?
Aspirin, or acetylsalicylic acid (ASA), is unique because it offers a simple, cost-effective approach to managing unruptured brain aneurysms. Unlike standard treatments that often involve invasive procedures or complex medications, aspirin works by reducing inflammation and preventing blood clots, potentially making coiling procedures safer and more effective. Researchers are excited about this treatment because it could streamline care and reduce risks for patients undergoing these procedures, offering a straightforward addition to existing medical protocols.
What evidence suggests that this treatment might be an effective treatment for unruptured brain aneurysm?
Research has shown that aspirin might help reduce the risk of brain aneurysms growing or bursting. Some studies indicate that taking aspirin can lower the chance of aneurysm growth by up to 80%. Aspirin may reduce inflammation in the blood vessel walls, making them less likely to expand or break. Other research suggests that aspirin can also decrease the risk of aneurysms bursting. In this trial, participants in the active arm will receive acetylsalicylic acid (ASA) to evaluate its effectiveness in preventing complications in people with unruptured brain aneurysms. Overall, these studies support the idea that aspirin could be an effective treatment for this purpose.12345
Who Is on the Research Team?
Craig Doram, PEng
Principal Investigator
University of Calgary
Linda Andersen, PhD
Principal Investigator
University of Calgary
Mohammed A Almekhlafi, MD MSc FRCPC
Principal Investigator
University of Calgary
Mayank Goyal, MD PhD FRCPC
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for adults with unruptured brain aneurysms suitable for coiling-only treatment. They must be functionally independent and able to give consent. Excluded are those needing complex treatments, unable to take oral medication or undergo MRI, have certain medical risks like bleeding disorders, pregnant or breastfeeding women, and anyone on antiplatelet or anticoagulant therapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive oral acetylsalicylic acid or placebo starting 3 days prior to the coiling procedure, on the procedure day, and for one day post-procedure
Follow-up
Participants are monitored for clinical or silent strokes and other complications, with assessments at discharge and Day 90
What Are the Treatments Tested in This Trial?
Interventions
- Acetyl Salicylate
Trial Overview
The study tests if taking acetylsalicylic acid (325 mg/day for 5 days) is better than a placebo in preventing strokes after endovascular coiling of unruptured brain aneurysms. The main goal is to see if there's a stroke at discharge time by clinical exam and MRI, with follow-up functional outcome data collected on Day 90.
How Is the Trial Designed?
2
Treatment groups
Active Control
Placebo Group
Acetylsalicylic acid (ASA) will be given orally at a dose of 324 mg to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.
Lactose100-mg tablets to be taken daily starting 3 days prior to the planned coiling procedure day, on the procedure day, and for one-day post-procedure.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Citations
The Role of Aspirin in the Management of Intracranial ... - PMC
Our results showed that aspirin use, regardless of frequency and duration, was associated with a statistically significant decreased risk of UIA growth (OR 0.25 ...
Aspirin May Decrease Growth of Intracranial Aneurysms
aspirin treatment was associated with an 80 percent lower risk for aneurysm growth compared to an alternative treatment.
Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT).
We have designed this study to test whether there is a measurable reduction in inflammation in walls of brain aneurysms. take aspirin daily for three months, ...
4.
researchgate.net
researchgate.net/publication/51699873_Aspirin_as_a_Promising_Agent_for_Decreasing_Incidence_of_Cerebral_Aneurysm_RuptureAspirin as a Promising Agent for Decreasing Incidence of ...
Findings from several studies also suggested that cerebral aneurysm rupture risk is reduced in patients taking aspirin [44, 45].Though whether ...
Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT) v1
In this study, participants known to have an aneurysm that is not planned for treatment and has not yet burst, take aspirin daily for three months, and have an ...
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