Clinical trial NCT03063541: Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms
Official title: Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Unruptured Intracranial Aneurysms
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: UMC Utrecht
name: Schwiete Stiftung, Mannheim, Germany
name: KKS Netzwerk
name: University of Hamburg-Eppendorf
First posted: 2017-02-24
Enrollment: 776
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: controlled open trial, randomized 1:1
Primary purpose: PREVENTION

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)


Eligibility criteria: 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

Primary outcomes:
measure: aneurysm rupture or growth
timeFrame: 36 months
Secondary outcomes:
measure: aneurysm volume
timeFrame: 36 months
measure: new aneurysm
timeFrame: 36 months
measure: therapy of aneurysm
timeFrame: 36 months
measure: stroke
timeFrame: 36 months
measure: myocard infarction
timeFrame: 36 months
measure: vascular death
timeFrame: 36 months
measure: major bleeding
timeFrame: 36 months
measure: death
timeFrame: 36 months
measure: achieved blood pressure
timeFrame: 36 months
measure: Incidence of Treatment-Emergent Adverse and Serious Adverse Events
timeFrame: 36 months
Other outcomes:
Locations:
city: Frankfurt am Main
country: Germany
facility: Department of Neurology and Neurosurgery, Goethe University
state: Hessen
city: Aachen
country: Germany
facility: Klinik für Neurochirurgie
city: Berlin
country: Germany
facility: Neurochirurgische Klinik
city: Düsseldorf
country: Germany
facility: Neurochirurgische Klinik
city: Erlangen
country: Germany
facility: Neurolgische Klinik
city: Essen
country: Germany
facility: Klinik für Neurochirurgie
city: Göttingen
country: Germany
facility: Klinik für Neurochirurgie
city: Hamburg
country: Germany
facility: Klinik für Neurochirurgie
city: Heidelberg
country: Germany
facility: Neurologische Universitätsklinik
city: Mannheim
country: Germany
facility: Department of Neurosurgery, University Hospital Mannheim
city: München
country: Germany
facility: Neurochirurgische Klinik und Poliklinik
city: Münster
country: Germany
facility: Universitätsklinikum Münster
city: Amsterdam
country: Netherlands
facility: AMC Department of Neurology
city: Groningen
country: Netherlands
facility: UMCG
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Nijmegen
country: Netherlands
facility: Neurochirurgisch Centrum CWZ
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Utrecht
country: Netherlands
facility: UMC
Study officials:
affiliation: UMM, Department of Neurosurgery
name: Nima Etminan, PD Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht, Department of Neurology and Neurosurgery
name: Mervyn D Vergouwen, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vergouwen MD, Rinkel GJ, Algra A, Fiehler J, Steinmetz H, Vajkoczy P, Rutten FH, Luntz S, Hanggi D, Etminan N. Prospective Randomized Open-label Trial to evaluate risk faCTor management in patients with Unruptured intracranial aneurysms: Study protocol. Int J Stroke. 2018 Dec;13(9):992-998. doi: 10.1177/1747493018790033. Epub 2018 Jul 18.