Unruptured Intracranial Aneurysms
Conditions
Brief summary
Purpose of this study is to assess the hypothesis that a strategy with acetylsalicylic acid (ASA) 100 mg/day, intensive blood pressure treatment (targeted systolic blood pressure below 120 mmHg), and a 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 standard blood pressure management, no blood pressure measuring device)
Interventions
DRUGAcetylsalicylic acid
100 mg daily as one tablet
Patients are encouraged to seek any therapy to have a systolic blood pressure of 120 or below. They will be provided with a blood pressure measurement device and are advised to control blood pressure daily.
Sponsors
UMC Utrecht
Schwiete Stiftung, Mannheim, Germany
KKS Netzwerk
University of Hamburg-Eppendorf
Universitätsmedizin Mannheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
observer blinding
Intervention model description
controlled open trial, randomized 1:1
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older with an intradural, saccular unruptured aneurysm (UIA) in whom it is decided not to intervene with preventive endovascular or neurosurgical repair of the aneurysm and who are monitored on a regular base for aneurysm growth * Last aneurysm imaging with either CTA/MRA/DSA within the last 3 months
Exclusion criteria
* All non-saccular UIAs or aneurysms related to arteriovenous malformations * Frequent ASA use and/or indication for a vitamin K antagonist, or direct oral anticoagulant (DOAC) treatment at baseline * Contra-indication for ASA * 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 * Chronic kidney disease stage IV and V (GFR \< 30 mL/min/1.73 m2) * Pregnancy and lactation * Participation in another clinical trial or observation period of competing trials, respectively * Life-expectancy \<3 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| aneurysm rupture or growth | 36 months | aneurysm rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH) or growth (increase in any aneurysm diameter by ≥1mm) on serial imaging (either two MR or CT angiographies) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| new aneurysm | 36 months | development of de novo aneurysm on serial imaging |
| therapy of aneurysm | 36 months | clipping/coiling during the study period |
| stroke | 36 months | any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging |
| myocard infarction | 36 months | myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography |
| aneurysm volume | 36 months | difference of aneurysm volume (in computerized measurements defined as increase of aneurysm volume in computerized measurements by \>10% and \>3mm3 or aneurysm shape (e.g. development of daughter sac) |
| major bleeding | 36 months | 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 |
| death | 36 months | death from all other causes |
| achieved blood pressure | 36 months | any data on blood pressure management used |
| Incidence of Treatment-Emergent Adverse and Serious Adverse Events | 36 months | all adverse and serious adverse events related to the experimental intervention |
| vascular death | 36 months | vascular death (including fatal stroke, fatal myocardial infarction, sudden death) |
Countries
Germany, Netherlands
Contacts
Primary ContactNima Etminan, PD Dr. med.
Backup ContactMervyn DI Vergouwen, M.D., Ph.D.
Outcome results
None listed