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Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms | Clinical Trials | Clareo Health

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

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

NCT03063541•Universitätsmedizin Mannheim

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (18)

Department of Neurology and Neurosurgery, Goethe University

Frankfurt am Main, Hesse, Germany

Klinik für Neurochirurgie

Aachen, Germany

Neurochirurgische Klinik

Berlin, Germany

Neurochirurgische Klinik

Düsseldorf, Germany

Neurolgische Klinik

Erlangen, Germany

Klinik für Neurochirurgie

Essen, Germany

Klinik für Neurochirurgie

Göttingen, Germany

Klinik für Neurochirurgie

Hamburg, Germany

Neurologische Universitätsklinik

Heidelberg, Germany

Department of Neurosurgery, University Hospital Mannheim

Mannheim, Germany

Key Dates

Start Date

September 21, 2017

Primary Completion Date

October 1, 2022

Completion Date

October 1, 2022

Last Updated

January 25, 2019

Enrollment

776

ESTIMATED participants

Conditions

Unruptured Intracranial Aneurysms

Interventions

Acetylsalicylic acid

DRUG

intensive blood pressure control

OTHER

Contacts

Nima Etminan, PD Dr. med.

CONTACT

+49 621 383-2360 Nima.Etminan@umm.de

Mervyn DI Vergouwen, M.D., Ph.D.

CONTACT

+31 88 75 50455 M.D.I.Vergouwen@umcutrecht.nl

Analysis of Thrombo-embolic Complications After Endovascular Treatment of Unruptured Intracranial Aneurysms

NCT02862756

Unruptured Intracranial Aneurysms

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 25, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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