Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms
NCT ID: NCT03063541
Last Updated: 2019-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
776 participants
INTERVENTIONAL
2017-09-21
2022-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Acetylsalicylic acid, BP-target 120
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
Acetylsalicylic acid
100 mg daily as one tablet
intensive blood pressure control
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.
standard care
blood pressure management according to guidelines
No interventions assigned to this group
Interventions
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Acetylsalicylic acid
100 mg daily as one tablet
intensive blood pressure control
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Last aneurysm imaging with either CTA/MRA/DSA within the last 3 months
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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UMC Utrecht
OTHER
Schwiete Stiftung, Mannheim, Germany
UNKNOWN
KKS Netzwerk
NETWORK
University of Hamburg-Eppendorf
OTHER
Universitätsmedizin Mannheim
OTHER
Responsible Party
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Nima Etminan
Vice Chair
Principal Investigators
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Nima Etminan, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
UMM, Department of Neurosurgery
Mervyn D Vergouwen, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht, Department of Neurology and Neurosurgery
Locations
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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
Neurochirurgische Klinik und Poliklinik
München, , Germany
Universitätsklinikum Münster
Münster, , Germany
AMC Department of Neurology
Amsterdam, , Netherlands
UMCG
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Neurochirurgisch Centrum CWZ
Nijmegen, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
UMC
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Kerim Beseoglu, Dr.
Role: backup
Peter A Ringleb, Prof. Dr.
Role: primary
References
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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.
Other Identifiers
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2017-000514-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
PROTECT-U_V2.2_20_Feb_2017
Identifier Type: -
Identifier Source: org_study_id
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