Unruptured Intracranial AneurysmsPhase 3PROTECT-UNCT03063541
Acetylsalicylic Acid Plus Intensive Blood Pressure Treatment in Patients With Unruptured Intracranial Aneurysms
A Phase 3 study testing Acetylsalicylic acid in people with Unruptured Intracranial Aneurysms, run by Universitätsmedizin Mannheim at 18 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Unruptured Intracranial Aneurysms
- What is being tested?
- Acetylsalicylic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 776 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 21 Sep 2017to Oct 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
Germany12 sites, 11 recruiting
- Recruiting
Klinik für Neurochirurgie
Aachen, 52074
Gerrit A Schubert, Prof. Dr., +49 241 8082420, gschubert@ukaachen.de
Rastislav Pjontek, Dr., rpjontek@ukaachen.de
- Recruiting
Neurochirurgische Klinik
Berlin, 13353
Peter Vajkoczy, Prof. Dr., +49 30 450 560900, peter.vajkoczy@charite.de
Lars Wessels, Dr., 030 450 56 ext. 0002, lars.wessels@charite.de
- Recruiting
Neurochirurgische Klinik
Düsseldorf, 40225
Athanasios Petridis, Prof. Dr., +49 211810 ext. 4514, athanasios.petridis@duesseldorf.de
Kerim Beseoglu, Dr.
- Recruiting
Neurolgische Klinik
Erlangen, 91054
Hagen Huttner, Prof. Dr., +4991318536597, hagen.huttner@uk-erlangen.de
Bernd Kallmünzer, Dr., bernd.kallmuenzer@uk-erlangen.de
- Recruiting
Klinik für Neurochirurgie
Essen, 45147
Ramazan Jabbarli, PD Dr., ramazan.jabbarli@uk-essen.de
Ramazan Jabbarli, PhD
- Recruiting
Department of Neurology and Neurosurgery, Goethe University
Frankfurt am Main, Hesse
Helmuth Steinmetz, Prof. Dr., +49 69 6301-5769, helmuth.steinmetz@em.uni-frankfurt.de
Jürgen Konczalla, PD Dr, J.Konczalla@med.uni-frankfurt.de
- Recruiting
Klinik für Neurochirurgie
Göttingen, 37037
Dorothe Mielke, Prof. Dr., dorothe.mielke@med.uni-goettingen.de
Katharina Lange, katharina.lange@med.uni-goettingen.de
- Recruiting
Klinik für Neurochirurgie
Hamburg, 20246
Nils O Schmidt, PD Dr., nschmidt@uke.de
Jan Regelsberger, Prof. Dr., j.regelsberger@uke.de
- Recruiting
Neurologische Universitätsklinik
Heidelberg, 69120
Peter A Ringleb, Prof. Dr., +496221 56- ext. 8243
Elisabeth Beyrle, +406221 563- ext. 8856, elisabeth.beyrle@med.uni-heidelberg.de
- Recruiting
Department of Neurosurgery, University Hospital Mannheim
Mannheim, 68167
Nima Etminan, PD Dr. med., +49-621-383-2360, nima.etminan@umm.de
Katharina Hackenberg, Dr.med., +49-621-383-2360, katharina.hackenberg@umm.de
- Active, not recruiting
Neurochirurgische Klinik und Poliklinik
München, 81675
- Recruiting
Universitätsklinikum Münster
Münster, 48149
Markus Holling, MD PhD, +49 251 / 83 -47482, hollingm@ukmuenster.de
Markus Holling, MD PhD
Netherlands6 sites, 6 recruiting
- Recruiting
AMC Department of Neurology
Amsterdam, 1105AZ
Yvo B. W. Roos, Prof. Dr., +31-20-5663942, y.b.roos@amc.uva.nl
Rita Sprengers, r.g.sprengers@amc.uva.nl
- Recruiting
UMCG
Groningen
Maarten Uyttenboogaart, Dr., m.uyttenboogaart@umcg.nl
Maarten Uyttenboogaart, Dr.
- Recruiting
Leiden University Medical Center
Leiden, 2300 RC
Ghislaine Holswilder, MD, g.holswilder@lumc.nl
A van der Meij, MD, a.van_der_meij@lumc.nl
- Recruiting
Neurochirurgisch Centrum CWZ
Nijmegen, 6500 GS
Jeroen Boogaarts, Dr., jeroen.boogaarts@radboudumc.nl
Viktoria Shimanskaya, Dr, vika.shimanskaya@radboudumc.nl
- Recruiting
Erasmus MC
Rotterdam, 3015 GD
Naziha el Ghannouti, +31 10 704 38 18, n.elghannouti@erasmusmc.nl
Bob Roozenbeek, MD PhD
- Recruiting
UMC
Utrecht
Mervyn D. I. Vergouwen, Dr., +31 (0)88 755 0455, M.D.I.Vergouwen@umcutrecht.nl
Jacco M. Westeneng, J.M.Westeneng-4@umcutrecht.nl
About this study
Official title: Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
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)
- Conditions
- Unruptured Intracranial Aneurysms
- Being tested
- Acetylsalicylic acid, intensive blood pressure control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic acidDrug
Also called aspirin
100 mg daily as one tablet
intensive blood pressure controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Acetylsalicylic acid, BP-target 120 | Experimental | 100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg Receives: Drug: Acetylsalicylic acid; Other: intensive blood pressure control |
| standard care | No intervention | blood pressure management according to guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Secondary outcomes (10)
aneurysm volume
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)
Measured: 36 months
new aneurysm
development of de novo aneurysm on serial imaging
Measured: 36 months
therapy of aneurysm
clipping/coiling during the study period
Measured: 36 months
stroke
any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging
Measured: 36 months
myocard infarction
myocardial infarction defined as increase of troponin, creatine-kinase MB and/or presence of new significant Q waves obtained in electrocardiography
Measured: 36 months
vascular death
vascular death (including fatal stroke, fatal myocardial infarction, sudden death)
Measured: 36 months
major bleeding
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
Measured: 36 months
death
death from all other causes
Measured: 36 months
achieved blood pressure
any data on blood pressure management used
Measured: 36 months
Incidence of Treatment-Emergent Adverse and Serious Adverse Events
all adverse and serious adverse events related to the experimental intervention
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start21 Sep 2017
- Primary completionOct 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unruptured Intracranial AneurysmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- controlled open trial, randomized 1:1
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 776 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitätsmedizin Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Schwiete Stiftung, Mannheim, Germany, KKS Netzwerk, University of Hamburg-Eppendorf
- Responsible party
- Principal investigator, Nima Etminan, Universitätsmedizin Mannheim
- Investigators
- Nima Etminan, PD Dr., Principal investigator, UMM, Department of NeurosurgeryMervyn D Vergouwen, MD,PhD, Principal investigator, UMC Utrecht, Department of Neurology and Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063541
- Sponsor's protocol ID
- PROTECT-U_V2.2_20_Feb_2017
- Other IDs
- 2017-000514-35, 2017
- Acronym
- PROTECT-U
- Status last verified
- Jan 2019
- First submitted
- 20 Feb 2017
- Last updated
- 25 Jan 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 30019634
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Open-label Trial to Evaluate Risk faCTor Management in Patients With Unruptured Intracranial Aneurysms
- ClinicalTrials.gov ID
- NCT03063541
- Acronym / sponsor ID
- PROTECT-U / PROTECT-U_V2.2_20_Feb_2017
- Conditions
- Unruptured Intracranial Aneurysms
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 776 participants (estimated)
- Lead sponsor
- Universitätsmedizin MannheimUniversity, hospital or other
- Collaborators
- UMC Utrecht, Schwiete Stiftung, Mannheim, Germany, KKS Netzwerk, University of Hamburg-Eppendorf
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- Oct 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- controlled open trial, randomized 1:1
| Arm | Type | Receives |
|---|---|---|
| Acetylsalicylic acid, BP-target 120 | Experimental | Drug: Acetylsalicylic acid, Other: intensive blood pressure control100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg |
| standard care | No intervention | –blood pressure management according to guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic acidAlso: aspirin100 mg daily as one tablet | Drug | Acetylsalicylic acid, BP-target 120 |
| intensive blood pressure controlPatients 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 | Acetylsalicylic acid, BP-target 120 |
Primary outcome
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)
10 secondary outcomes
aneurysm volume
Time frame: 36 months
new aneurysm
Time frame: 36 months
therapy of aneurysm
Time frame: 36 months
stroke
Time frame: 36 months
myocard infarction
Time frame: 36 months
vascular death
Time frame: 36 months
major bleeding
Time frame: 36 months
death
Time frame: 36 months
achieved blood pressure
Time frame: 36 months
Incidence of Treatment-Emergent Adverse and Serious Adverse Events
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2019.
- Background: PubMed 30019634Vergouwen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nima Etminan, PD Dr. principal investigator
UMM, Department of Neurosurgery
Mervyn D Vergouwen, MD,PhD principal investigator
UMC Utrecht, Department of Neurology and Neurosurgery
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Acetylsalicylic acid in people with Unruptured Intracranial Aneurysms, run by Universitätsmedizin Mannheim at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nima Etminan, PD Dr. med. (+49 621 383-2360, Nima.Etminan@umm.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
aneurysm rupture or growth (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03063541, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2019.