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

Universitätsmedizin Mannheim776 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

776

Conditions

Unruptured Intracranial Aneurysms

Interventions

Acetylsalicylic acidDRUG

100 mg daily as one tablet

intensive blood pressure controlOTHER

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Department of Neurology and Neurosurgery, Goethe University

Frankfurt am Main, Hesse, Germany

RECRUITING

Klinik für Neurochirurgie

Outcomes

Primary Outcomes

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)

Time frame: 36 months

Secondary Outcomes

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)

Time frame: 36 months

new aneurysm

development of de novo aneurysm on serial imaging

Time frame: 36 months

therapy of aneurysm

clipping/coiling during the study period

Time frame: 36 months

stroke

any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging

Time frame: 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

Time frame: 36 months

vascular death

vascular death (including fatal stroke, fatal myocardial infarction, sudden death)

Time frame: 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

Central Contacts

Nima Etminan, PD Dr. med.

CONTACT

+49 621 383-2360 Nima.Etminan@umm.de

Mervyn DI Vergouwen, M.D., Ph.D.

CONTACT

+31 88 75 50455 M.D.I.Vergouwen@umcutrecht.nl

Data from ClinicalTrials.gov

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