Intracranial aneurysm - Dilated brain artery
Conditions
Interventions
Patients will be randomized to either:
- a strategy with ASA 100mg/day and intensive blood pressure treatment
(targeted systolic blood pressure below 120 mm Hg) with daily measurements
using a home
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty Mannheim
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be aneurysm rupture or growth on serial imaging (MR- or CT-angiography). Aneurysm growth is defined as an increase in any aneurysm diameter by >= 1mm at 36±6 months on the intervention. Aneurysm rupture or growth will be assessed centrally by two independent trial radiologists, who will be blinded to the treatment allocation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Any growth or rupture of aneurysm during follow-up irrespective of the duration of trial participation 2. Difference of aneurysm volume (defined as increase of aneurysm volume in computerized measurements from source images by >10% and >3mm3) or aneurysm shape (e.g. development of daughter sac) 3. Development of de novo aneurysm on serial imaging 4. Clipping/coiling during the study period 5. Any ischemic or hemorrhagic stroke, defined as clinical symptoms of stroke AND a compatible lesion on imaging 6. Myocardial infarction defined as increase of Troponin, CKMB and/or presence of new significant Q waves obtained in ECG 7. Vascular death (including fatal stroke, fatal myocardial infarction, sudden death) 8. Death from all other causes 9. Major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates 10. Blood pressure; any data on blood pressure management used 11. Safety aspects (adverse and serious adverse events) 12. Quality of life | — |
Countries
Netherlands
Outcome results
None listed