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

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What is this study about?

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.

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 Treatment assignment

You will be assigned to receive either:

Acetylsalicylic acid (aspirin) tablets for oral use

Placebo tablets (containing lactose monohydrate) for oral use

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 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 Follow-up period – 90 days

You will be monitored for:

Any changes in brain function

Possible complications

Your overall recovery progress

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 Study?

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 Study?

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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Rennes	Rennes	France
Glqqwc Hbxjoddpysh Uonsxfysymuga Plhne Pbytrdqehvz Ek Njxhmkebncfz	Paris	France
Ayynwcsayx Pyvumrlv Hfvxnjcb Dw Mootyhhcy	Marseille	France
Chjhsw Huqhoiwjkwv Rikyjovh Uidfurjprboim De Tsecl	Tours	France
Crlu Dm Nhdcd	Vandoeuvre Les Nancy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	05.05.2023

Trial locations

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.

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 ID:

2024-517674-23-00

Protocol code:

DR220153

NCT ID:

NCT04192955

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?