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ClinicalTrials.gov ID

NCT03063541

Lead Sponsor

Universitätsmedizin MannheimOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Phase 3

Enrollment

776Estimated

Last Update Posted

Jan 25, 2019Actual

Start Date

Sep 21, 2017Actual

Primary Completion Date

Oct 2022Estimated

Completion Date

Oct 2022Estimated

Official Title

Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms

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)

• Unruptured Intracranial Aneurysms

• Acetylsalicylic acid
• intensive blood pressure control

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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 Purpose

Prevention

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

Universitätsmedizin MannheimOTHER

Collaborators

UMC UtrechtOTHER

Schwiete Stiftung, Mannheim, GermanyUNKNOWN

KKS NetzwerkNETWORK

University of Hamburg-EppendorfOTHER

m.uyttenboogaart@umcg.nl

M.D.I.Vergouwen@umcutrecht.nl+31 (0)88 755 0455