Factor XA - Inhibition in RENal Patients With Non-valvular Atrial Fibrillation - Observational Registry
- Conditions
- Non-valvular Atrial Fibrillation (NVAF)Chronic Kidney Disease (CKD)
- Registration Number
- NCT02663076
- Lead Sponsor
- GWT-TUD GmbH
- Brief Summary
The multicenter registry will collect clinical data from 1600 patients with non valvular atrial fibrillation (NVAF) and chronic kidney disease (eGFR 15-49 mL/min per 1.73 m2).
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.
- Detailed Description
This is a prospective registry allowing a structured, non-interventional collection of data. Participating physicians will not be subject to any instructions with regard to the diagnosis and therapy of their patients. All patient treatment is carried out within clinical routine, at the discretion of the physician and according to existing treatment guidelines.
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1700
- male and female patients, age ≥ 18 years
- 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 according to the local product information for the respective anticoagulation treatment
- planned treatment with other anticoagulants
- expected renal-replacement therapy within the next 3 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method major bleeding 12 month decline in eGFR in mL/min per 1.73 m2 12 month all-cause mortality 12 month major cardiovascular events (MACE) 12 month symptomatic venous thromboembolic events 12 month net-clinical benefit (stroke and other thromboembolic events, major bleeding, and all-cause mortality) 12 month TIA, stroke or systemic arterial embolism 12 month
- Secondary Outcome Measures
Name Time Method initiation of chronic renal replacement therapy 12 month length of hospitalizations 12 month, 18 month reasons for OAC therapy discontinuation 12 month, 18 month descriptive analysis of reasons for therapy discontinuation (verbal description by investigator)
eGFR < 15 mL/min per 1.73 m2 (CKD Stage 5 Dialysis and Non-Dialysis) 12 month doubling of serum creatine concentration 12 month acute kidney injury (AKI) events defined as acute kidney injury associated with either hospitalization or emergency department visit, where AKI event is the lead diagnosis 12 month, 18 month causes of hospitalizations 12 month, 18 month eGFR decline of ≥ 30% 12 month rates of hospitalizations 12 month, 18 month persistence with OAC therapy 12 month, 18 month
Trial Locations
- Locations (116)
Centre Hospitalier EpiCURA-Baudour
🇧🇪Baudour, Belgium
CUB Hôpital ERASME
🇧🇪Bruxelles, Belgium
CHU de Charleroi
🇧🇪Charleroi, Belgium
Clinique Sainte-Isabelle
🇫🇷Abbeville, France
CHU Amiens
🇫🇷Amiens, France
CH Abbeville
🇫🇷Abbeville, 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
CHRU Brest-Hôpital la Cavale Blanche
🇫🇷Brest, France
CHU Bordeaux-Hôpital Pellegrin
🇫🇷Bordeaux, France
CHU Clermont Ferrand
🇫🇷Clermont Ferrand, France
CH Cholet
🇫🇷Cholet, France
Hôpital Henri Mondor (AP-HP)
🇫🇷Créteil, France
Hôpital Louis Mourier (AP-HP)
🇫🇷Colombes, France
CH de Compiègne-Noyon (CHNC)
🇫🇷Compiègne, France
CHD Vendée
🇫🇷La Roche sur yon, France
CHG de Chartres-Hôpital Général Louis Pasteur
🇫🇷Le Coudray, France
CHU Nantes-site Hotel Dieu
🇫🇷Nantes, France
CHR Metz-Thionville, Hôpital de Mercy
🇫🇷Metz, France
CHU Carémeau
🇫🇷Nimes, 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
🇫🇷Trevenans, France
Kardiologische Praxis
🇩🇪Bad Homburg, Germany
FA für Innere Medizin
🇩🇪Bergisch Gladbach, Germany
Franziskus-Krankenhaus Berlin
🇩🇪Berlin, Germany
Schilddrüsenzentrum Bergstrasse/Praxis Innere Medizin
🇩🇪Bensheim, Germany
Praxis Rankestrasse
🇩🇪Berlin, Germany
MVZ Dres. Ramdohr
🇩🇪Berlin, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Vivantes Klinikum im Friedrichshain
🇩🇪Berlin, Germany
Praxis
🇩🇪Königsbrück, Germany
St. Joseph Krankenhaus Berlin-Tempelhof GmbH
🇩🇪Berlin, Germany
Facharzt für Allgemeinmedizin
🇩🇪Berlin, Germany
Kardiologische Arztpraxis
🇩🇪Borsdorf, Germany
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
Studienzentrum Schwittay
🇩🇪Böhlen, Germany
Krankenhaus Buchholz
🇩🇪Buchholz, Germany
Kardiologische Partnerschaftsgesellschaft
🇩🇪Cottbus, Germany
Gemeinschaftspraxis Kellner und Ehrhardt
🇩🇪Camburg, Germany
Klinikum Coburg GmbH
🇩🇪Coburg, Germany
Kardiovaskuläres Zentrum Darmstadt
🇩🇪Darmstadt, Germany
ZID- Zentrum für Innere Medizin Dachau
🇩🇪Dachau, Germany
Klinikum Dortmund GmbH
🇩🇪Dortmund, Germany
Praxisklinik Herzkreislauf am Wasaplatz
🇩🇪Dresden, Germany
Kardiologie Dortmund
🇩🇪Dortmund, Germany
Nephrologische Praxis
🇩🇪Dortmund, Germany
Praxis Dr. med Steffen Fischer
🇩🇪Dresden, Germany
Universitätsklinikum Carl Gustav Carus Dresden
🇩🇪Dresden, Germany
Praxis Dr. med. Christoph Axthelm & Kollegen
🇩🇪Pirna, Germany
Gemeinschaftspraxis Dr. med. Sybille Jänsch
🇩🇪Dresden, Germany
Praxis Dr. med. Frank Richard
🇩🇪Erfurt, Germany
Gemeinschaftspraxis im Altstadtcarree, Kardiologie
🇩🇪Fulda, Germany
Klinikum Esslingen GmbH
🇩🇪Esslingen, Germany
MVZ Prof. Mathey, Prof. Schofer GmbH
🇩🇪Hamburg, Germany
Herzpraxis Altona
🇩🇪Hamburg, Germany
Zentrum für Nieren-, Hochdruck und Stoffwechselerkrankungen
🇩🇪Hannover, Germany
Universitätsklinikum des Saarlandes
🇩🇪Homburg, Germany
DOKUSAN
🇩🇪Herne, 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
Uniklinik Köln
🇩🇪Köln, 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
🇩🇪Nürnberg, Germany
Praxis für Innere Medizin
🇩🇪Nürnberg, Germany
Klinikum Nürnberg Süd
🇩🇪Nürnberg, Germany
via medis Nierenzentrum Oldenburg MVZ
🇩🇪Oldenburg, Germany
Internistische Gemeinschaftspraxis
🇩🇪Passau, Germany
Fachärztin für Allgemeinmedizin
🇩🇪Osnabrück, Germany
MVZ Birkenallee
🇩🇪Papenburg, Germany
Cardiologicum Prina
🇩🇪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
Praxis Dr. med. Jörg Brosche
🇩🇪Weinböhla, Germany
Gemeinschaftspraxis Drs. Grosskopf
🇩🇪Wallerfing, Germany
Kliniken Nordoberpfalz AG
🇩🇪Weiden, Germany
Kardiologische Praxis Dr. med. Ayham Al Zoebi
🇩🇪Wermsdorf, Germany
Ev. Krankenhaus Witten gGmbH
🇩🇪Witten, Germany
Kantonsspital Aarau AG
🇨🇭Aarau, Switzerland
Klinik Hirslanden
🇨🇭Zürich, Switzerland
Kantonsspital Baden AG
🇨🇭Baden, Switzerland
Medizinische Universitätsklinik
🇦🇹Graz, Austria
Krankenhaus Hietzing mit Neurologischem Zentrum Rosenhügel
🇦🇹Wien, Austria
Krankenhaus der Elisabethinen Linz
🇦🇹Linz, Austria
Krankenhaus St. Josef Braunau
🇦🇹Braunau Am Inn, Austria
Centre Hospitalier Régional de la Citadelle
🇧🇪Liège, Belgium
Centre Hospitalier Chrétien (CHC) St Joseph
🇧🇪Liège, Belgium
Centre Hospitalier Universiatire du SART-TILMAN
🇧🇪Liège, Belgium
Allgemeines Krankenhaus der STadt Linz
🇦🇹Linz, Austria
Meidzinische Universität Wien
🇦🇹Wien, Austria
Medizinische Universität Wien
🇦🇹Wien, Austria
Sozialmedizinischer Zentrum-Süd Kaiser-Franz-Josef-Spital
🇦🇹Wien, Austria
Centre Hospitalier de Wallonie Picarde (Chwapi)
🇧🇪Tournai, Belgium