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

Last updated: January 23, 2019
Sponsor: Universitätsmedizin Mannheim
Overall Status: Active - Recruiting

Phase

3

Condition

Aneurysm

Treatment

N/A

Clinical Study ID

NCT03063541
PROTECT-U_V2.2_20_Feb_2017
2017-000514-35
  • Ages > 18
  • All Genders

Study 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

Inclusion Criteria:

  • Patients 18 years or older with an intradural, saccular unruptured aneurysm (UIA) inwhom it is decided not to intervene with preventive endovascular or neurosurgicalrepair 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

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 oralanticoagulant (DOAC) treatment at baseline

  • Contra-indication for ASA

  • History of hypersensitivity to ASA or to any other drug with similar chemicalstructure 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

Study Design

Total Participants: 776
Study Start date:
September 21, 2017
Estimated Completion Date:
October 31, 2022

Connect with a study center

  • Department of Neurology and Neurosurgery, Goethe University

    Frankfurt am Main, Hessen
    Germany

    Active - Recruiting

  • Klinik für Neurochirurgie

    Aachen, 52074
    Germany

    Active - Recruiting

  • Neurochirurgische Klinik

    Berlin, 13353
    Germany

    Active - Recruiting

  • Neurochirurgische Klinik

    Düsseldorf, 40225
    Germany

    Active - Recruiting

  • Neurolgische Klinik

    Erlangen, 91054
    Germany

    Active - Recruiting

  • Klinik für Neurochirurgie

    Essen, 45147
    Germany

    Active - Recruiting

  • Klinik für Neurochirurgie

    Göttingen, 37037
    Germany

    Active - Recruiting

  • Klinik für Neurochirurgie

    Hamburg, 20246
    Germany

    Active - Recruiting

  • Neurologische Universitätsklinik

    Heidelberg, 69120
    Germany

    Active - Recruiting

  • Department of Neurosurgery, University Hospital Mannheim

    Mannheim, 68167
    Germany

    Active - Recruiting

  • Neurochirurgische Klinik und Poliklinik

    München, 81675
    Germany

    Site Not Available

  • Universitätsklinikum Münster

    Münster, 48149
    Germany

    Active - Recruiting

  • AMC Department of Neurology

    Amsterdam, 1105AZ
    Netherlands

    Active - Recruiting

  • UMCG

    Groningen,
    Netherlands

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, 2300 RC
    Netherlands

    Active - Recruiting

  • Neurochirurgisch Centrum CWZ

    Nijmegen, 6500 GS
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, 3015 GD
    Netherlands

    Active - Recruiting

  • UMC

    Utrecht,
    Netherlands

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.