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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universitätsmedizin Mannheim
• Collaborators: KKS Netzwerk; Schwiete Stiftung, Mannheim, Germany; UMC Utrecht; University of Hamburg; University of Hamburg-Eppendorf
• Treatments: Aspirin

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