Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
NCT ID: NCT02663076
Last Updated: 2022-07-19
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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COMPLETED
1700 participants
OBSERVATIONAL
2016-04-30
2022-04-04
Brief Summary
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The overall objective of this registry is to assess chronic kidney disease (CKD) progression and clinical outcomes with regard to anticoagulation strategies in NVAF patients with eGFR 15-49 mL/min per 1.73 m2 in routine clinical practice.
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Detailed Description
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This registry will be carried out as an investigator-initiated, multicentre, prospective, non-interventional and observational registry at approximately 160 sites in Germany, Austria, Switzerland, France, Belgium and Luxembourg.
The registry will collect clinical data of approximately 1600 patients with CKD (eGFR 15-49 mL/min per 1.73 m2) and NVAF receiving rivaroxaban, OAC with VKA, or no AC therapy, who are prospectively followed for a flexible duration with a minimal follow-up duration of 12 months until study end is announced (planned minimum 360 days / planned maximum 84 months).
The plan of the registry is to include at least 1600 patients with CKD and NVAF and rivaroxaban therapy or VKA therapy or no AC therapy.
The aim is to include at least 700 patients with rivaroxaban therapy and VKA therapy, respectively. Into the exploratory treatment arm of patients receiving no AC therapy about 100 patients will be included.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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VKA - Vitamin K antagonist group
VKAs used in correspondence with the national guidelines for therapy of NVAF in the respective country.
No interventions assigned to this group
Rivaroxaban group
Rivaroxaban used in correspondence with the national guidelines for therapy of NVAF in the respective country.
No interventions assigned to this group
noAC group
noAC used in correspondence with the national guidelines for therapy of NVAF in the respective country.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* CKD with eGFR 15 - 49 mL/min per 1.73 m2
* non-valvular atrial fibrillation (NVAF) with indication for anticoagulation therapy
* a treatment strategy for the ≥ 3 previous months before enrolment with either: rivaroxaban or VKA (OAC cohorts) or no anticoagulation (no AC cohort)
* informed consent
* availability for follow up
* life expectancy of ≥6 months
Exclusion Criteria
* expected renal-replacement therapy within the next 3 months
18 Years
ALL
No
Sponsors
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ClinStat GmbH
UNKNOWN
GWT-TUD GmbH
OTHER
Responsible Party
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Principal Investigators
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Reinhold Kreutz, Prof. Dr.
Role: STUDY_DIRECTOR
Charite University, Berlin, Germany
Jan Beyer-Westendorf, PD Dr.
Role: STUDY_CHAIR
University Clinic Technical University Dresden
Locations
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Krankenhaus St. Josef Braunau
Braunau am Inn, , Austria
Medizinische Universitätsklinik
Graz, , Austria
Allgemeines Krankenhaus der STadt Linz
Linz, , Austria
Krankenhaus der Elisabethinen Linz
Linz, , Austria
Medizinische Universität Wien
Vienna, , Austria
Meidzinische Universität Wien
Vienna, , Austria
Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
Vienna, , Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
Vienna, , Austria
Centre Hospitalier EpiCURA-Baudour
Baudour, , Belgium
CUB Hôpital ERASME
Brussels, , Belgium
CHU de Charleroi
Charleroi, , Belgium
Centre Hospitalier Régional de la Citadelle
Liège, , Belgium
Centre Hospitalier Chrétien (CHC) St Joseph
Liège, , Belgium
Centre Hospitalier Régional de la Citadelle
Liège, , Belgium
Centre Hospitalier Universiatire du SART-TILMAN
Liège, , Belgium
Centre Hospitalier de Wallonie Picarde (Chwapi)
Tournai, , Belgium
Clinique Sainte-Isabelle
Abbeville, , France
CH Abbeville
Abbeville, , France
CHU Amiens
Amiens, , France
CHU Angers
Angers, , France
CHU Angers
Angers, , France
CH Argenteuil Centre Hospitalier Victor Dupouy
Argenteuil, , France
CHU Avicenne (AP-HP)
Bobigny, , France
CHU Bordeaux-Hôpital Saint André
Bordeaux, , France
CHU Bordeaux-Hôpital Pellegrin
Bordeaux, , France
CHRU Brest-Hôpital la Cavale Blanche
Brest, , France
CH Cholet
Cholet, , France
CHU Clermont Ferrand
Clermont-Ferrand, , France
Hôpital Louis Mourier (AP-HP)
Colombes, , France
CH de Compiègne-Noyon (CHNC)
Compiègne, , France
Hôpital Henri Mondor (AP-HP)
Créteil, , France
CHD Vendée
La Roche-sur-Yon, , France
CHG de Chartres-Hôpital Général Louis Pasteur
Le Coudray, , France
CHR Metz-Thionville, Hôpital de Mercy
Metz, , France
CHU Nantes-site Hotel Dieu
Nantes, , France
CHU Carémeau
Nîmes, , France
Pitié-Salpètrière Hospital (AP-HP)
Paris, , France
Claude Bernard - Bichat Hospital
Paris, , France
Hôpital Bretonneau (AP-HP)
Paris, , France
CHU Nantes-Hôpital nord Laennec
Saint-Herblain, , France
CHRU Strasbourg Nouvel Hôpital Civil
Strasbourg, , France
CHI Toulon La Seyne sur mer - Hopital Sainte Musse
Toulon, , France
Hôpital Nord Franche Comté
Trévenans, , France
Kardiologische Praxis
Bad Homburg, , Germany
Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin
Bensheim, , Germany
FA für Innere Medizin
Bergisch Gladbach, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Vivantes Klinikum im Friedrichshain
Berlin, , Germany
Franziskus-Krankenhaus Berlin
Berlin, , Germany
Praxis Rankestrasse
Berlin, , Germany
MVZ Dres. Ramdohr
Berlin, , Germany
St. Joseph Krankenhaus Berlin-Tempelhof GmbH
Berlin, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Facharzt für Allgemeinmedizin
Berlin, , Germany
Praxis
Berlin, , Germany
Kardiologische Arztpraxis
Borsdorf, , Germany
Studienzentrum Schwittay
Böhlen, , Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, , Germany
Krankenhaus Buchholz
Buchholz, , Germany
Gemeinschaftspraxis Kellner und Ehrhardt
Camburg, , Germany
Klinikum Coburg GmbH
Coburg, , Germany
Uniklinik Köln
Cologne, , Germany
Kardiologische Partnerschaftsgesellschaft
Cottbus, , Germany
ZID- Zentrum für Innere Medizin Dachau
Dachau, , Germany
Kardiovaskuläres Zentrum Darmstadt
Darmstadt, , Germany
Klinikum Dortmund GmbH
Dortmund, , Germany
Kardiologie Dortmund
Dortmund, , Germany
Nephrologische Praxis
Dortmund, , Germany
Praxisklinik Herzkreislauf am Wasaplatz
Dresden, , Germany
Praxis Dr. med Steffen Fischer
Dresden, , Germany
Praxis Dr. med. Christoph Axthelm & Kollegen
Dresden, , Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, , Germany
Gemeinschaftspraxis Dr. med. Sybille Jänsch
Dresden, , Germany
Praxis Dr. med. Frank Richard
Erfurt, , Germany
Klinikum Esslingen GmbH
Esslingen am Neckar, , Germany
Gemeinschaftspraxis im Altstadtcarree, Kardiologie
Fulda, , Germany
MVZ Prof. Mathey, Prof. Schofer GmbH
Hamburg, , Germany
Herzpraxis Altona
Hamburg, , Germany
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
Hanover, , Germany
DOKUSAN
Herne, , Germany
Universitätsklinikum des Saarlandes
Homburg, , Germany
Praxisnetz Dr. Haaß & Kollegen
Inden, , Germany
Westpfalz-Klinikum GmbH
Kaiserslautern, , Germany
Studienzentrum Dr. med. Karl-Friedrich Appel
Kassel, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Gemeinschaftspraxis Wittwer, Bargemann, Baar
Kiel, , Germany
Gemeinschaftspraxis Scheuermann & Persicke
Kornwestheim, , Germany
Praxis
Königsbrück, , Germany
Eickenhof Dialyse - Gemeinschaftspraxis
Langenhagen, , Germany
Klinikum St. Georg GmbH
Leipzig, , Germany
Klinikum Leverkusen
Leverkusen, , Germany
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Mainz, , Germany
Universitätsklinikum Marburg
Marburg, , Germany
Praxis Dr. med. Jens Taggeselle
Markkleeberg, , Germany
Internistisches Facharztzentrum
Memmingen, , Germany
Herz-Gefäß-Zentrum Nymphenburg
München, , Germany
Marienkrankenhaus Klinikum St. Elisabeth
Neuwied, , Germany
Kardiologische Gemeinschaftspraxis
Nienburg, , Germany
Kardiologie am Weißen Turm
Nuremberg, , Germany
Praxis für Innere Medizin
Nuremberg, , Germany
Klinikum Nürnberg Süd
Nuremberg, , Germany
via medis Nierenzentrum Oldenburg MVZ
Oldenburg, , Germany
Fachärztin für Allgemeinmedizin
Osnabrück, , Germany
MVZ Birkenallee
Papenburg, , Germany
Internistische Gemeinschaftspraxis
Passau, , Germany
Cardiologicum Prina
Pirna, , Germany
Praxis Dr. med. Christoph Axthelm & Kollegen
Pirna, , Germany
Paracelsus-Harz-Klinik
Quedlinburg, , Germany
KardioPrax Remscheid
Remscheid, , Germany
Zentrum für Prävention und Rehabilitation
Siegen, , Germany
Studienzentrum der Herzklinik Ulm GbR
Ulm, , Germany
Internistische Praxis Vellmar
Vellmar, , Germany
Schwarzwald-Baar-Klinikum
Villingen-Schwenningen, , Germany
Gemeinschaftspraxis Drs. Grosskopf
Wallerfing, , Germany
Kliniken Nordoberpfalz AG
Weiden, , Germany
Praxis Dr. med. Jörg Brosche
Weinböhla, , Germany
Kardiologische Praxis Dr. med. Ayham Al Zoebi
Wermsdorf, , Germany
Ev. Krankenhaus Witten gGmbH
Witten, , Germany
Kantonsspital Aarau AG
Aarau, , Switzerland
Kantonsspital Baden AG
Baden, , Switzerland
Klinik Hirslanden
Zurich, , Switzerland
Countries
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Other Identifiers
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XARENO-Registry
Identifier Type: -
Identifier Source: org_study_id
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