BridgeMD
Prospective Randomized Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U)
EU CTIS ID: 2024-517236-22-00
What this study is testing
The primary aim of this study is to assess the hypothesis that a strategy with low-dose ASA (81-100mg/day) and intensive blood pressure treatment (targeted systolic blood pressure below 120mmHg) with weekly measurements using a home blood pressure measuring device reduces the risk of aneurysm rupture or growth compared with standard care (i.e. no ASA, blood pressure management according to guidelines which usually advise treatment if systolic blood pressure exceeds 140mmHg, and no home device for weekly blood pressure measurements).
- 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
- Patient with at least one intradural, saccular unruptured aneurysm in whom it is decided not to intervene with preventive neurosurgical or endovascular aneurysm repair and who are monitored on a regular basis for aneurysm growth
- 18 years or older
- Last aneurysm imaging with either CTA/MRA within the last 3 months
- Ability of subject to understand character and individual consequences of clinical trial
- Not legally incapacitated
- Written informed consent (must be available before enrolment in the trial)
You likely can't join if
- All non-saccular UIAs or aneurysms related to arteriovenous malformations
- Participation in another interventional clinical trial
- Life-expectancy <3 years
- Daily ASA already prescribed for another indication
- Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) treatment at baseline
- History of hypersensitivity/allergy to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
See the full eligibility criteria
- Patient with at least one intradural, saccular unruptured aneurysm in whom it is decided not to intervene with preventive neurosurgical or endovascular aneurysm repair and who are monitored on a regular basis for aneurysm growth
- 18 years or older
- Last aneurysm imaging with either CTA/MRA within the last 3 months
- Ability of subject to understand character and individual consequences of clinical trial
- Not legally incapacitated
- Written informed consent (must be available before enrolment in the trial)
- For women with childbearing potential adequate contraception.
- All non-saccular UIAs or aneurysms related to arteriovenous malformations
- Participation in another interventional clinical trial
- Life-expectancy <3 years
- Daily ASA already prescribed for another indication
- Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) treatment at baseline
- History of hypersensitivity/allergy to ASA or to any other drug with similar chemical structure or to any excipient present in the pharmaceutical form of ASA
- History of asthma induced by salicylates or other anti-inflammatory drugs
- Other contra-indications for ASA not yet mentioned in the dosage of 81-100 mg/day (e.g. bleeding disorders, gastric ulcers and/or intestinal ulcers, acute liver failure of kidney failure, severe heart failure, treatment with methotrexate in a dosage 15 mg/week or above)
- Use of another platelet aggregation inhibitor, which in combination with ASA would give an unacceptable risk of side effects/complications
- Chronic kidney disease stage IV and V (GFR <30mL/min/1.73m2)
- Pregnancy and lactation
The study team makes the final eligibility decision.
Where it's taking place
- Canada
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, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Canada. Enter your location above to see the nearest site and check your eligibility.
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.