Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms
PROTECT-U
Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
2 other identifiers
interventional
776
2 countries
18
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2017
Longer than P75 for phase_3
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2017
CompletedFirst Posted
Study publicly available on registry
February 24, 2017
CompletedStudy Start
First participant enrolled
September 21, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJanuary 25, 2019
January 1, 2019
5 years
February 20, 2017
January 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
aneurysm rupture or growth
aneurysm rupture (i.e. aneurysmal subarachnoid hemorrhage, SAH) or growth (increase in any aneurysm diameter by ≥1mm) on serial imaging (either two MR or CT angiographies)
36 months
Secondary Outcomes (10)
aneurysm volume
36 months
new aneurysm
36 months
therapy of aneurysm
36 months
stroke
36 months
myocard infarction
36 months
- +5 more secondary outcomes
Study Arms (2)
Acetylsalicylic acid, BP-target 120
EXPERIMENTAL100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
standard care
NO INTERVENTIONblood pressure management according to guidelines
Interventions
100 mg daily as one tablet
Patients are encouraged to seek any therapy to have a systolic blood pressure of 120 or below. They will be provided with a blood pressure measurement device and are advised to control blood pressure daily.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universitätsmedizin Mannheimlead
- UMC Utrechtcollaborator
- Schwiete Stiftung, Mannheim, Germanycollaborator
- KKS Netzwerkcollaborator
- University of Hamburg-Eppendorfcollaborator
Study Sites (18)
Department of Neurology and Neurosurgery, Goethe University
Frankfurt am Main, Hesse, Germany
Klinik für Neurochirurgie
Aachen, 52074, Germany
Neurochirurgische Klinik
Berlin, 13353, Germany
Neurochirurgische Klinik
Düsseldorf, 40225, Germany
Neurolgische Klinik
Erlangen, 91054, Germany
Klinik für Neurochirurgie
Essen, 45147, Germany
Klinik für Neurochirurgie
Göttingen, 37037, Germany
Klinik für Neurochirurgie
Hamburg, 20246, Germany
Neurologische Universitätsklinik
Heidelberg, 69120, Germany
Department of Neurosurgery, University Hospital Mannheim
Mannheim, 68167, Germany
Neurochirurgische Klinik und Poliklinik
München, 81675, Germany
Universitätsklinikum Münster
Münster, 48149, Germany
AMC Department of Neurology
Amsterdam, 1105AZ, Netherlands
UMCG
Groningen, Netherlands
Leiden University Medical Center
Leiden, 2300 RC, Netherlands
Neurochirurgisch Centrum CWZ
Nijmegen, 6500 GS, Netherlands
Erasmus MC
Rotterdam, 3015 GD, Netherlands
UMC
Utrecht, Netherlands
Related Publications (1)
Vergouwen MD, Rinkel GJ, Algra A, Fiehler J, Steinmetz H, Vajkoczy P, Rutten FH, Luntz S, Hanggi D, Etminan N. Prospective Randomized Open-label Trial to evaluate risk faCTor management in patients with Unruptured intracranial aneurysms: Study protocol. Int J Stroke. 2018 Dec;13(9):992-998. doi: 10.1177/1747493018790033. Epub 2018 Jul 18.
PMID: 30019634BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nima Etminan, PD Dr.
UMM, Department of Neurosurgery
- PRINCIPAL INVESTIGATOR
Mervyn D Vergouwen, MD,PhD
UMC Utrecht, Department of Neurology and Neurosurgery
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- observer blinding
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice Chair
Study Record Dates
First Submitted
February 20, 2017
First Posted
February 24, 2017
Study Start
September 21, 2017
Primary Completion
October 1, 2022
Study Completion
October 1, 2022
Last Updated
January 25, 2019
Record last verified: 2019-01