Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms

Study Overview
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Brief Summary
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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)

Official Title
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Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms

Conditions
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Unruptured Intracranial Aneurysms

Intervention / Treatment
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* Drug: Acetylsalicylic acid
* Other: intensive blood pressure control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: controlled open trial, randomized 1:1
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acetylsalicylic acid, BP-target 120<br>100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg | Drug: Acetylsalicylic acid<br>* 100 mg daily as one tablet<br>* Other names: aspirin;Other: intensive blood pressure control<br>* 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.<br>|
| No Intervention: standard care<br>blood pressure management according to guidelines | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aneurysm rupture or growth | 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) | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aneurysm volume | 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) | 36 months | 
| new aneurysm | development of de novo aneurysm on serial imaging | 36 months | 
| therapy of aneurysm | clipping/coiling during the study period | 36 months | 
| stroke | any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging | 36 months | 
| myocard infarction | myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography | 36 months | 
| vascular death | vascular death (including fatal stroke, fatal myocardial infarction, sudden death) | 36 months | 
| major bleeding | 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 | 36 months | 
| death | death from all other causes | 36 months | 
| achieved blood pressure | any data on blood pressure management used | 36 months | 
| Incidence of Treatment-Emergent Adverse and Serious Adverse Events | all adverse and serious adverse events related to the experimental intervention | 36 months |