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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-000514-35 | EudraCT Number |
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| Name | Class |
|---|---|
| UMC Utrecht | OTHER |
| Schwiete Stiftung, Mannheim, Germany | UNKNOWN |
| KKS Netzwerk | NETWORK |
| University of Hamburg-Eppendorf |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetylsalicylic acid, BP-target 120 | Experimental | 100 mg ASA plus intensified blood pressure management. Recommended systolic blood pressure 120 mm/Hg |
|
| standard care | No Intervention | blood pressure management according to guidelines |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic acid | Drug | 100 mg daily as one tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 36 months |
| new aneurysm |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| Nima Etminan, PD Dr. | UMM, Department of Neurosurgery | Principal Investigator |
| Mervyn D Vergouwen, MD,PhD | UMC Utrecht, Department of Neurology and Neurosurgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology and Neurosurgery, Goethe University | Recruiting | Frankfurt am Main | Hesse | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30019634 | Background | 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. |
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| OTHER |
controlled open trial, randomized 1:1
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observer blinding
| intensive blood pressure control | Other | 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. |
|
development of de novo aneurysm on serial imaging
| 36 months |
| therapy of aneurysm | clipping/coiling during the study period | 36 months |
| stroke | any ischemic or haemorrhagic stroke, defined as clinical symptoms for stroke AND a compatible lesion on imaging | 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 | 36 months |
| vascular death | vascular death (including fatal stroke, fatal myocardial infarction, sudden death) | 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 | 36 months |
| death | death from all other causes | 36 months |
| achieved blood pressure | any data on blood pressure management used | 36 months |
| Incidence of Treatment-Emergent Adverse and Serious Adverse Events | all adverse and serious adverse events related to the experimental intervention | 36 months |
| Klinik für Neurochirurgie | Recruiting | Aachen | 52074 | Germany |
|
| Neurochirurgische Klinik | Recruiting | Berlin | 13353 | Germany |
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| Neurochirurgische Klinik | Recruiting | Düsseldorf | 40225 | Germany |
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| Neurolgische Klinik | Recruiting | Erlangen | 91054 | Germany |
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| Klinik für Neurochirurgie | Recruiting | Essen | 45147 | Germany |
|
| Klinik für Neurochirurgie | Recruiting | Göttingen | 37037 | Germany |
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| Klinik für Neurochirurgie | Recruiting | Hamburg | 20246 | Germany |
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| Neurologische Universitätsklinik | Recruiting | Heidelberg | 69120 | Germany |
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| Department of Neurosurgery, University Hospital Mannheim | Recruiting | Mannheim | 68167 | Germany |
|
| Neurochirurgische Klinik und Poliklinik | Active, not recruiting | München | 81675 | Germany |
| Universitätsklinikum Münster | Recruiting | Münster | 48149 | Germany |
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| AMC Department of Neurology | Recruiting | Amsterdam | 1105AZ | Netherlands |
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| UMCG | Recruiting | Groningen | Netherlands |
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| Leiden University Medical Center | Recruiting | Leiden | 2300 RC | Netherlands |
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| Neurochirurgisch Centrum CWZ | Recruiting | Nijmegen | 6500 GS | Netherlands |
|
| Erasmus MC | Recruiting | Rotterdam | 3015 GD | Netherlands |
|
| UMC | Recruiting | Utrecht | Netherlands |
|
| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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