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

  • STATUS
    Recruiting
  • End date
    Oct 22, 2022
  • participants needed
    776
  • sponsor
    Universitätsmedizin Mannheim
Updated on 22 January 2021

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)

Details
Condition Unruptured Intracranial Aneurysms
Treatment Acetylsalicylic acid, intensive blood pressure control
Clinical Study IdentifierNCT03063541
SponsorUniversitätsmedizin Mannheim
Last Modified on22 January 2021

Eligibility

Yes No Not Sure

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
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