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Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms (PROTECT-U)

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ClinicalTrials.gov Identifier: NCT03063541
Recruitment Status : Unknown
Verified January 2019 by Nima Etminan, Universitätsmedizin Mannheim.
Recruitment status was:  Recruiting
First Posted : February 24, 2017
Last Update Posted : January 25, 2019
Sponsor:
Collaborators:
UMC Utrecht
Schwiete Stiftung, Mannheim, Germany
KKS Netzwerk
University of Hamburg-Eppendorf
Information provided by (Responsible Party):
Nima Etminan, Universitätsmedizin Mannheim

Study Description
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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)

Condition or disease Intervention/treatment Phase
Unruptured Intracranial Aneurysms Drug: Acetylsalicylic acid Other: intensive blood pressure control Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 776 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: controlled open trial, randomized 1:1
Masking: Single (Outcomes Assessor)
Masking Description: observer blinding
Primary Purpose: Prevention
Official Title: Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
Actual Study Start Date : September 21, 2017
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arms and Interventions
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Arm Intervention/treatment
Experimental: Acetylsalicylic acid, BP-target 120
100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg
 Drug: Acetylsalicylic acid
100 mg daily as one tablet
Other Name: aspirin

Other: 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.
No Intervention: standard care
blood pressure management according to guidelines


Outcome Measures
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Primary Outcome Measures :
  1. aneurysm rupture or growth [ Time Frame: 36 months ]
    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)


Secondary Outcome Measures :
  1. aneurysm volume [ Time Frame: 36 months ]
    difference of aneurysm volume (in computerized measurements defined as increase of aneurysm volume in computerized measurements by >10% and >3mm3 or aneurysm shape (e.g. development of daughter sac)

  2. new aneurysm [ Time Frame: 36 months ]
    development of de novo aneurysm on serial imaging

  3. therapy of aneurysm [ Time Frame: 36 months ]
    clipping/coiling during the study period

  4. stroke [ Time Frame: 36 months ]
    any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging

  5. myocard infarction [ Time Frame: 36 months ]
    myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography

  6. vascular death [ Time Frame: 36 months ]
    vascular death (including fatal stroke, fatal myocardial infarction, sudden death)

  7. major bleeding [ Time Frame: 36 months ]
    major spontaneous bleeding requiring hospitalisation defined as substantially disabling bleeding, intraocular bleeding leading to the loss of vision, or bleeding necessitating the transfusion of at least 2 units of erythrocyte concentrates

  8. death [ Time Frame: 36 months ]
    death from all other causes

  9. achieved blood pressure [ Time Frame: 36 months ]
    any data on blood pressure management used

  10. Incidence of Treatment-Emergent Adverse and Serious Adverse Events [ Time Frame: 36 months ]
    all adverse and serious adverse events related to the experimental intervention


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03063541


Contacts
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Contact: Nima Etminan, PD Dr. med. +49 621 383-2360 Nima.Etminan@umm.de
Contact: Mervyn DI Vergouwen, M.D., Ph.D. +31 88 75 50455 M.D.I.Vergouwen@umcutrecht.nl

Locations
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Germany
Department of Neurology and Neurosurgery, Goethe University Recruiting
Frankfurt am Main, Hessen, Germany
Contact: Helmuth Steinmetz, Prof. Dr.    +49 69 6301-5769    helmuth.steinmetz@em.uni-frankfurt.de   
Contact: Jürgen Konczalla, PD Dr       J.Konczalla@med.uni-frankfurt.de   
Principal Investigator: Helmuth Steinmetz, Prof. Dr.         
Klinik für Neurochirurgie Recruiting
Aachen, Germany, 52074
Contact: Gerrit A Schubert, Prof. Dr.    +49 241 8082420    gschubert@ukaachen.de   
Contact: Rastislav Pjontek, Dr.       rpjontek@ukaachen.de   
Principal Investigator: Gerrit A Schubert, Prof. Dr.         
Neurochirurgische Klinik Recruiting
Berlin, Germany, 13353
Contact: Peter Vajkoczy, Prof. Dr.    +49 30 450 560900    peter.vajkoczy@charite.de   
Contact: Lars Wessels, Dr.    030 450 56 ext 0002    lars.wessels@charite.de   
Principal Investigator: Peter Vajkoczy, Prof. Dr.         
Neurochirurgische Klinik Recruiting
Düsseldorf, Germany, 40225
Contact: Athanasios Petridis, Prof. Dr.    +49 211810 ext 4514    athanasios.petridis@duesseldorf.de   
Contact: Kerim Beseoglu, Dr.         
Neurolgische Klinik Recruiting
Erlangen, Germany, 91054
Contact: Hagen Huttner, Prof. Dr.    +4991318536597    hagen.huttner@uk-erlangen.de   
Contact: Bernd Kallmünzer, Dr.       bernd.kallmuenzer@uk-erlangen.de   
Principal Investigator: Hagen Huttner, Prof. Dr.         
Klinik für Neurochirurgie Recruiting
Essen, Germany, 45147
Contact: Ramazan Jabbarli, PD Dr.       ramazan.jabbarli@uk-essen.de   
Principal Investigator: Ramazan Jabbarli, PhD         
Klinik für Neurochirurgie Recruiting
Göttingen, Germany, 37037
Contact: Dorothe Mielke, Prof. Dr.       dorothe.mielke@med.uni-goettingen.de   
Contact: Katharina Lange       katharina.lange@med.uni-goettingen.de   
Principal Investigator: Veit Rohde, Prof. Dr.         
Klinik für Neurochirurgie Recruiting
Hamburg, Germany, 20246
Contact: Nils O Schmidt, PD Dr.       nschmidt@uke.de   
Contact: Jan Regelsberger, Prof. Dr.       j.regelsberger@uke.de   
Principal Investigator: Nils O Schmidt, PD Dr.         
Neurologische Universitätsklinik Recruiting
Heidelberg, Germany, 69120
Contact: Peter A Ringleb, Prof. Dr.    +496221 56- ext 8243      
Contact: Elisabeth Beyrle    +406221 563- ext 8856    elisabeth.beyrle@med.uni-heidelberg.de   
Principal Investigator: Peter A Ringleb, Prof. Dr.         
Department of Neurosurgery, University Hospital Mannheim Recruiting
Mannheim, Germany, 68167
Contact: Nima Etminan, PD Dr. med.    +49-621-383-2360    nima.etminan@umm.de   
Contact: Katharina Hackenberg, Dr.med.    +49-621-383-2360    katharina.hackenberg@umm.de   
Principal Investigator: Nima Etminan, PD Dr.med.         
Sub-Investigator: Daniel Haenggi, Prof. Dr.med.         
Neurochirurgische Klinik und Poliklinik Active, not recruiting
München, Germany, 81675
Universitätsklinikum Münster Recruiting
Münster, Germany, 48149
Contact: Markus Holling, MD PhD    +49 251 / 83 -47482    hollingm@ukmuenster.de   
Principal Investigator: Markus Holling, MD PhD         
Netherlands
AMC Department of Neurology Recruiting
Amsterdam, Netherlands, 1105AZ
Contact: Yvo B. W. Roos, Prof. Dr.    +31-20-5663942    y.b.roos@amc.uva.nl   
Contact: Rita Sprengers       r.g.sprengers@amc.uva.nl   
Principal Investigator: Yvo Roos, Prof. Dr.         
UMCG Recruiting
Groningen, Netherlands
Contact: Maarten Uyttenboogaart, Dr.       m.uyttenboogaart@umcg.nl   
Principal Investigator: Maarten Uyttenboogaart, Dr.         
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 RC
Contact: Ghislaine Holswilder, MD       g.holswilder@lumc.nl   
Contact: A van der Meij, MD       a.van_der_meij@lumc.nl   
Principal Investigator: Marieke JH Wermer, MD PhD FESO         
Neurochirurgisch Centrum CWZ Recruiting
Nijmegen, Netherlands, 6500 GS
Contact: Jeroen Boogaarts, Dr.       jeroen.boogaarts@radboudumc.nl   
Contact: Viktoria Shimanskaya, Dr       vika.shimanskaya@radboudumc.nl   
Principal Investigator: Jeroen Boogarts, Dr.         
Erasmus MC Recruiting
Rotterdam, Netherlands, 3015 GD
Contact: Naziha el Ghannouti    +31 10 704 38 18    n.elghannouti@erasmusmc.nl   
Principal Investigator: Bob Roozenbeek, MD PhD         
UMC Recruiting
Utrecht, Netherlands
Contact: Mervyn D. I. Vergouwen, Dr.    +31 (0)88 755 0455    M.D.I.Vergouwen@umcutrecht.nl   
Contact: Jacco M. Westeneng       J.M.Westeneng-4@umcutrecht.nl   
Principal Investigator: Mervyn D. I. Vergouwen, Dr.         
Sponsors and Collaborators
Universitätsmedizin Mannheim
UMC Utrecht
Schwiete Stiftung, Mannheim, Germany
KKS Netzwerk
University of Hamburg-Eppendorf
Investigators
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Principal Investigator: Nima Etminan, PD Dr. UMM, Department of Neurosurgery
Principal Investigator: Mervyn D Vergouwen, MD,PhD UMC Utrecht, Department of Neurology and Neurosurgery
More Information
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Publications:

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Responsible Party: Nima Etminan, Vice Chair, Universitätsmedizin Mannheim
ClinicalTrials.gov Identifier: NCT03063541    
Other Study ID Numbers: PROTECT-U_V2.2_20_Feb_2017
2017-000514-35 ( EudraCT Number )
First Posted: February 24, 2017    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics