Prospective Randomised Open-label Trial to Evaluate risk faCTor management in patients with Unruptured intracranial aneurysms (PROTECT-U)

Phase 3

Recruiting

• Conditions: Intracranial aneurysm - Dilated brain artery; 10002363

• Registration Number: NL-OMON52612
• Lead Sponsor: Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 355

Inclusion 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

Exclusion Criteria

• All non-saccular UIAs or aneurysms related to arteriovenous malformations
• Daily ASA already prescribed for another indication
• Use of a vitamin K antagonist or direct oral anticoagulant (DOAC) at baseline
• History of hypersensitivity 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 ASA or other anti-inflammatory drugs
• Other contra-indications for ASA not yet mentioned, in the dosage of 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 < 30 mL/min/1.73 m2)
• Pregnancy and lactation
• Participation in any other clinical trial
• Life-expectancy <3 years

Study & Design

• Study Type: Interventional
• Study Design: Not specified