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Study of acetylsalicylic acid to prevent stroke in patients undergoing brain aneurysm coiling procedure

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial focuses on patients with unruptured brain aneurysms who are scheduled to undergo a procedure called endovascular coiling, which is a minimally invasive treatment to prevent aneurysm rupture. The study aims to determine if using acetylsalicylic acid (commonly known as aspirin) around the time of the procedure can reduce the occurrence of strokes compared to placebo treatment.

The study medication, Salospir, contains acetylsalicylic acid and will be given by mouth. Participants will receive either acetylsalicylic acid or a placebo in identical-looking capsules. The treatment will last for 5 days, with participants taking one dose daily. The medication or placebo will be given before and after the coiling procedure.

During the study, doctors will monitor participants for any signs of stroke or other complications. Brain imaging using MRI will be performed to check for any small areas of stroke that might not be noticeable to the patient. The study will also track participants' recovery and brain function for up to one year after the procedure to understand how the treatment affects their overall outcomes.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial evaluation

    Your eligibility for the study will be evaluated based on the following criteria:

    You must be 18 years or older

    You must have an unruptured brain aneurysm that can be treated with a procedure called coiling

    You need to be functionally independent in daily activities

    The study will continue until May 5, 2027

  2. Step 2

    Treatment assignment

    You will be assigned to receive either:

    Acetylsalicylic acid (aspirin) tablets for oral use

    Or

    Placebo tablets (containing lactose monohydrate) for oral use

  3. Step 3

    Brain aneurysm procedure

    You will undergo a coiling procedure to treat the brain aneurysm

    This involves placing tiny coils in the aneurysm through blood vessels

  4. Step 4

    Follow-up examination - Day 5

    12-48 hours after the coiling procedure, you will have a brain MRI scan

    The scan will check for any small areas affected by the procedure

  5. Step 5

    Follow-up period - 90 days

    You will be monitored for:

    Any changes in brain function

    Possible complications

    Your overall recovery progress

  6. Step 6

    Long-term follow-up - 1 year

    Your cognitive abilities will be evaluated

    Your daily living activities will be assessed

    Your overall quality of life will be monitored

Who can join the trial?

8 criteria

  • Must be at least 18 years old
  • Have an unruptured brain aneurysm (a bulge in a blood vessel in the brain that has not burst) that can be treated with a procedure called coiling (a minimally invasive technique where tiny metal coils are inserted into the aneurysm)
  • Be able to perform daily activities independently, as measured by a modified Rankin scale score less than 3 (this means the person can care for themselves with minimal assistance)
  • Must be willing and able to:
    • Sign an informed consent form
    • Participate in all required study visits and procedures
    • Complete the entire duration of the study
    • Can be either male or female
    • Must be scheduled for elective endovascular coiling (planned, non-emergency procedure to treat the aneurysm)

Who cannot join the trial?

14 criteria

  • History of allergic reactions or intolerance to aspirin or similar medications
  • Active bleeding disorders or significant risk of bleeding
  • Recent major surgery within the last 30 days
  • Current use of blood-thinning medications (anticoagulants) that cannot be safely stopped
  • Pregnant women or women planning to become pregnant during the study period
  • History of stomach ulcers or gastrointestinal bleeding
  • Severe kidney or liver disease
  • Previous stroke (a condition where blood flow to part of the brain is interrupted) within the last 6 months
  • Uncontrolled high blood pressure
  • Participation in another clinical trial within the last 30 days
  • Inability to provide informed consent
  • Known bleeding in the brain (intracranial hemorrhage)
  • Severe heart disease or recent heart attack
  • Age under 18 or over 75 years
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Investigated drugs

Acetylsalicylic acid (ASA) is a common medication also known as aspirin. It helps prevent blood clots by making blood platelets less sticky. In this trial, it is being studied to see if it can reduce the risk of stroke in patients who are undergoing a brain procedure called endovascular coiling for unruptured brain aneurysms. This medication is taken by mouth and has been used for many years to prevent heart attacks and strokes in people at risk for these conditions.

What is already known about the treatment

Acetylsalicylic acid (ASA) - A widely used oral medication commonly known as aspirin, which belongs to the class of nonsteroidal anti-inflammatory drugs (NSAIDs). This medication is administered in tablet form and works by inhibiting platelet aggregation and reducing blood clotting by blocking the production of thromboxane. In neurosurgical procedures, particularly in endovascular coiling of brain aneurysms, ASA is being studied for its potential to reduce the risk of stroke and thromboembolic complications during and after the procedure by preventing blood clot formation. The medication has a well-established safety profile and is commonly used in cardiovascular disease prevention, making it a promising candidate for perioperative stroke prevention in neurovascular procedures.

Investigated diseases

  • Brain Aneurysm

    A brain aneurysm is a bulge or ballooning in a blood vessel in the brain, occurring when the vessel wall becomes weak and expands outward. This condition develops at points where blood vessels branch or divide, most commonly at the base of the brain. The aneurysm can remain stable for years without causing symptoms. When unruptured, a brain aneurysm may exert pressure on surrounding brain tissue or nerves. Some aneurysms can grow larger over time, increasing the risk of complications.

  • Embolic Stroke

    A type of stroke that occurs when a blood clot (embolus) forms in one part of the body and travels through the bloodstream to the brain. These clots can block blood vessels, cutting off blood supply to parts of the brain tissue. The blockage prevents oxygen and nutrients from reaching brain cells in the affected area. Embolic strokes can develop suddenly and may cause immediate symptoms.

  • Cognitive Decline

    A condition characterized by a noticeable decrease in mental abilities, including memory, thinking speed, language, and judgment. It involves deterioration in cognitive functions beyond what is expected from normal aging. The decline can affect daily activities and social functioning. The condition can develop gradually and may vary in severity.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517674-23-00Protocol codeDR220153Estimated enrolment200 patientsSponsorUniversity Of Calgary

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).