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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01671007
Other study ID # 1160.136
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 22, 2012
Est. completion date December 13, 2019

Study information

Verified date December 2020
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. For administrative purposes the study is divided into two protocol numbers: 1160.129 for non-EU (European Union) and non-EEA (European Economic Area) countries, and 1160.136 for EU and EEA countries. The total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Recruitment information / eligibility

Status Completed
Enrollment 10471
Est. completion date December 13, 2019
Est. primary completion date December 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: 1. Age =>18 years at enrollment 2. Male or female patient (or legally acceptable representative) willing and able to provide written informed consent 3. Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke. Other inclusion criteria apply. Exclusion criteria: 1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime; 3. AF with a generally reversible cause; 4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated Other exclusion criteria apply

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth Bad Pirawarth
Austria Kepler Univ. Klinikum Linz Linz
Austria KH der Barmherzigen Schwestern Linz Linz
Austria Ordination Dr. Martin Koschutnik, Oberwart Oberwart
Austria AKH - Medical University of Vienna Wien
Austria KH d. Barmherzigen Brüder Wien, Neurologie Wien
Belgium Namur - HOSP St-Luc de Bouge Bouge/Namur
Belgium AZ Sint-Lucas Brugge
Belgium Brussels - HOSP Europe (Ste-Elisabeth) Brussel
Belgium Brussels - HOSP St-Jan Brussel
Belgium ULB Hopital Erasme Bruxelles
Belgium Ziekenhuis Oost-Limburg - Campus Sint-Jan Genk
Belgium Liège - HOSP CHR de la Citadelle Liège
Belgium Ottignies - HOSP St-Pierre Ottignies
Belgium Tienen - PRAC De Wolf, Luc Tienen
Bulgaria MHAT "Deva Maria", Dept. of Cardiology, Burgas Burgas
Bulgaria MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak Kazanlak
Bulgaria UMHAT Sv.Georgi EAD Plovdiv
Bulgaria MHAT, Fourth Dept. of Internal Medicine, Rousse Rousse
Bulgaria MHAT Akta Medika OOD, Sevlievo Sevlievo
Bulgaria Multiprofile Hospital for Active Treatment, Sliven Sliven
Bulgaria Diagnostic & Consultancy Center "Ascendent", Sofia Sofia
Bulgaria MHAT "National Cardiology Hosp." Cardiology Dept., Sofia Sofia
Bulgaria MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia Sofia
Bulgaria MHAT, "Vita" Surgery Department, Sofia Sofia
Bulgaria University Multiprofile Hospital 'Alexandrovska', Sofia Sofia
Bulgaria UMHAT, Clinic of Cardiology, Stara Zagora Stara Zagora
Bulgaria Medical Military Academy MHAT Varna Varna
Bulgaria Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol Yambol
Croatia Magdalena-Special Hosp.f.Cardiovas.Surgery,Krapinske Toplice Krapinske Toplice
Croatia Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija Opatija
Croatia Clinical Hospital Split Split
Croatia General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept Zadar
Croatia Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb Zagreb
Croatia Polyclinic St. Luke, Cardiology Dept., Zagreb Zagreb
Croatia Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb Zagreb
Croatia Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb Zagreb
Croatia University hospital center Zagreb Zagreb
Croatia University hospital center Zagreb Zagreb
Czechia Cardiology Private Practice, Brno Brno
Czechia University Hospital Brno Brno
Czechia Cardiocentrum, Private Practice, Kladno Kladno
Czechia Cardiology Private Practice Litovel
Czechia Cardiology Private Practice, Praha Praha 5
Czechia Cardiology Private Practice, Roznov pod Radhostem Roznov pod Radhostem
Denmark Forskningens Hus Aalborg
Denmark Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd. Esbjerg
Denmark Herlev and Gentofte Hospital Herlev
Denmark Nordsjællands Hospital - Hillerød Hillerød
Denmark Kolding Sygehus Kolding
Denmark Odense University Hospital Odense
Estonia East Tallinn Central Hospital Tallin
Estonia North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin Tallinn
France HOP Général, Cardio, Abbeville Abbeville
France HOP d'Agen, Cardio, Agen Agen
France HOP d'Aix en Provence, cardio, Aix-en-Provence Aix en Provence
France HOP Général, Cardio, Abbeville Aix en Provence
France HOP Louis Pasteur, Cardio, Bagnols sur Ceze Bagnols sur Ceze
France HOP Bar le Duc, Pneumo, Bar le Duc Bar le Duc
France HOP de Bayonne Bayonne
France HOP Jean Minjoz Besancon
France CAB Berdagué P, Cardio, Beziers Beziers
France CAB Breton Dr Nicolas Beziers
France HOP de Béziers Béziers
France CLI Tivoli Bordeaux
France HOP Saint-André Bordeaux
France HOP Ambroise Paré Boulogne-Billancourt
France HOP Fleyriat, GERIA, Bourg-en-Bresse Bour-en-Bresse
France HOP de la Cavale Blanche Brest
France CLI les Cedres, Cardio, Brive La Gaillarde Brive La Gaillarde
France CAB Cadinot Dr D, Broglie Broglie
France CAB Frappé T, MG, BRUAY LA BUISSIERE Bruay la Buissière
France HOP Côte de Nacre Caen
France HOP Saint Martin, cardio, Caen Caen
France CAB Brunschwig, Cardio, Cannes Cannes
France HOP William Morey, Cardio, Chalon-Sur-Saône Chalon-Sur-Saône
France CAB Loiselet P Cherbourg
France CAB Brunehaut M, Cardio, Clermont Ferrand Clermont Ferrand
France HOP Gabriel-Montpied Clermont Ferrand
France HOP Sud Francilien Corbeil Essonnes
France HOP Sud Francilien, Cardio, Corbeil-Essonnes Corbeil-Essonnes
France HOP Henri Mondor Creteil
France HOP Bocage Dijon
France HOP Louis Pasteur, Cardio, Dole Dole
France CTRE Evecquemont, Cardio, Evecquemont Evecquemont
France HOP du Val d'Ariège, Cardio, Foix Foix
France HOP Michallon La Tronche
France CAB Benhalima B, Cardio, Le bourget Le Bourget
France HOP André Mignot Le Chesnay
France HOP Louis Pasteur, Cardio, Le Coudray Le Coudray
France HOP Le Mans Le Mans
France CAB Phan Cao Phai, Cardio, Levallois Perret Levallois Perret
France CLI Libournais, Cardio, Libourne Libourne
France HOP Robert Boulin, cardio, Libourne Libourne
France CLI de la Louviere Lille
France CLI le Colombier, Cardio, Limoges Limoges
France HOP St Joseph-St Luc, Cardio, Lyon Lyon cedex 7
France CAB Gartenlaub O, Cardio, Maison Alfort Maisons Alfort
France CAB Scala P-J Marseille
France CAB Scemama J Marseille
France CAB vial, Cardio, Marseille Marseille
France CAB, Salem A, Cardio, Marseille Marseille
France HOP Européen Marseille
France HOP Timone Marseille cedex 5
France HOP des Rayettes Martigues
France HOP de la région d'Annecy, Cardio, Metz-Tessy Metz-Tessy
France CAB Dillinger J, MG, Mondelange Mondelange
France CLI de Montargis, Cardio, Montargis Montargis
France CLI du Pont de Chaume Montauban
France HOP Raincy Montfermeil, Cardio, Montfermeil Montfermeil
France HOP Arnaud de Villeneuve Montpellier
France CAB Prunier L, Cardio, Montreuil Montreuil
France HOP Central, Neuro, Nancy Nancy
France HOP de Courbevoie, Spécialités Med, Neuilly sur Seine Neuilly sur Seine
France CAB Jamon Y, Cardio, Nîmes Nimes
France HOP Carémeau Nîmes
France CLI Les Franciscaines, cardio, Nïmes Nïmes
France HOP Orléans, Cardio, Orléans Orléans
France CAB Audouin P, Cardio, Paris Paris
France CAB Cohen S, Paris Paris
France CAB Poulain F, Paris Paris
France CLI Turin, Cardio, Paris Paris
France HOP Européen G. Pompidou Paris
France HOP Pontchaillou Rennes Cedex
France CAB Duvilla N, Cardio, Rouen Rouen
France CAB Dascotte O, Cardio, St André lez Lille Saint André lez Lille
France CAB Lequeux B, Cardio, Saint Benoit Saint Benoit
France HOP Privé de la Loire, Cardio, Saint Etienne Saint Etienne
France CAB Dary P, Cardio, St-Yrieix-la-Perche Saint-Yrieix-la-Perche
France CAB Tessier P, Cardio, St Raphael St Raphael
France CAB Muller J-J, Cardio, Strasbourg Strasbourg
France CLI de l'Ormeau, Cardio, Tarbes Tarbes
France CAB Houppe Nousse MP, Cardio, Thionville Thionville
France HOP du Léman Thonon-les-bains
France HOP Sainte Musse Toulon
France HOP Rangueil Toulouse
France HOP Cardio, Tourcoing Tourcoing
France CAB Leprince P, MG, Tours Tours
France HOP Trousseau Tours
France CLI Village de Santé, Cardio, Trélaze Trelaze
France HOP Valence, Cardio, Valence Valence
France HOP Bretagne Atlantique, Cardio, Vannes Vannes
France CAB Lejay D, MG, Vieux Condé Vieux Condé
France CAB Schaupp T, MG, Vihiers Vihiers
Germany Bezirkskrankenhaus, Ansbach Ansbach
Germany Kerckhoff-Klinik, Bad Nauheim Bad Nauheim
Germany Neurologische Klinik GmbH, Bad Neustadt Bad Neustadt/Saale
Germany Sozialstiftung Bamberg Bamberg
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Evangelisches Elisabeth-Krankenhaus, Berlin Mitte Berlin
Germany Kardiologische Praxis Dr. Jochen Bott Berlin
Germany Praxis Dr. Altmann, Berlin Berlin
Germany Praxis Dr. Claus, 10969 Berlin Berlin
Germany Praxis Dr. Rieker, Berlin Berlin
Germany Praxisgemeinschaft Dres. Weinrich Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Vivantes Netzwerk für Gesundheit GmbH Berlin
Germany Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH Bochum
Germany Gesundheit Nord gGmbH | Klinikverbund Bremen Bremen
Germany Klinikum Bremerhaven Bremerhaven
Germany Herz- und Gefaesszentrum am Neumarkt Celle
Germany Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz Chemnitz
Germany Klinikum Coburg gGmbH Coburg
Germany HELIOS Amper Kliniken, Dachau Dachau
Germany Kardiologische Praxisgemeinschaft,Darmstadt Darmstadt
Germany Praxis Dr. Rybak, Dessau Dessau-Roßlau
Germany Klinikum Lippe-Detmold GmbH Detmold
Germany Kardiologischen Gemeinschaftspraxis Dinslaken Dinslaken
Germany Praxis Dr. med. Bernhard-Paul Lodde Dortmund
Germany Praxisklinik Herz und Gefäße Dresden
Germany Universitätsklinikum Carl Gustav Carus Dresden Dresden
Germany Evangelisches Krankenhaus Düsseldorf Düsseldorf
Germany Universitätsklinikum Erlangen Erlangen
Germany Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH Essen
Germany Klinikum Esslingen GmbH Esslingen
Germany Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz Greiz
Germany Asklepios Klinik Barmbek Hamburg
Germany Asklepios Klinik Harburg Hamburg
Germany Asklepios Klinik St. Geort Hamburg
Germany Universitätsklinikum Hamburg-Eppendorf Hamburg
Germany Praxis Herz im Zentrum Laske Hannover
Germany Universitätsklinikum Heidelberg Heidelberg
Germany Klinikum Ingolstadt GmbH Ingolstadt
Germany Praxis Dr. Mibach, Itzehoe Itzehoe
Germany Universitätsklinikum Jena Jena
Germany Kardiologische Gemeinschaftspraxis Kassel Kassel
Germany Praxis Dr. med. Frickel Siegfried Kempen
Germany Praxis Dr. med. Matthias Gabelmann Kirchzarten
Germany St. Antonius-Hospital, Kleve Kleve
Germany Praxis für Kardiologie, Köln Köln
Germany Herzzentrum Leipzig GmbH Leipzig
Germany Universitätsklinikum Leipzig Leipzig
Germany Klinikum Leverkusen gGmbH, Leverkusen Leverkusen
Germany Cardio Centrum Ludwigsburg Ludwigsburg
Germany Klinikum der Stadt Ludwigshafen am Rhein gGmbH Ludwigshafen
Germany Universitätsklinikum Magdeburg A. ö. R. Magdeburg
Germany Gemeinsachftspraxis Regner/Schmitt/Kros, Mainz Mainz
Germany Praxis Dr.med. Jens Taggeselle, Markkleeberg Markkleeberg
Germany Klinikum Memmingen Memmingen
Germany Johannes Wesling Klinikum Minden
Germany Kliniken Maria Hilf GmbH Moenchengladbach
Germany Praxis Dr. med. Norbert Schön, Mühldorf Mühldorf
Germany Herzzentrum ALTER HOF München München
Germany Klinikum rechts der Isar der Technischen Universität München München
Germany Universitätsklinikum Münster Münster
Germany Praxis Dr. med. Joachim Gmehling Nürnberg
Germany Klinikum Osnabrück GmbH Osnabrueck
Germany St. Vincenz-Krankenhaus GmbH Paderborn
Germany Kardiologische Praxis Papenburg Papenburg
Germany Kardiologisches Zentrum Peine Peine
Germany Städt. Krankenhaus, Pforzheim Pforzheim
Germany Kardiologische Gemeinschaftspraxis Potsdam Potsdam
Germany Kardiologische Gemeinschaftspraxis Rostock Rostock
Germany Kreisklinikum Siegen GmbH Siegen
Germany Berufsausübungsgemeinschaft Klein /Kratochvil Stuttgart
Germany Herzklinik Ulm Gemeinschaftspraxis Ulm
Germany Schwarzwald-Baar Klinikum Villingen-Schwenningen
Germany Kardiologische Praxis, Wermsdorf Wermsdorf
Germany MedKonsil, Wiesbaden Wiesbaden
Germany Kardiologische Gemeinschaftspraxis Wittenberg Wittenberg
Germany Universitätsklinikum Würzburg Würzburg
Greece University Hospital of Alexandroupolis Alexandroupoli
Greece "Korgialeneio-Benakeio" Hellenic Red Cross Hospital Athens
Greece Asclepion Voulas Hospital, Cardiological Clinic Athens
Greece Euroclinic of Athens Athens
Greece Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med. Athens
Greece General Hospital of Chalkida Chalkida
Greece General Hospital of Chania Chania
Greece General Hospital of Edessa, Cardiology Clinic Edessa
Greece Gen. Hosp. of Elefsina "Thriassio" Elefsina
Greece University General Hospital of Heraklion Herakleion, Crete
Greece Univ. Gen. Hosp. of Ioannina Ioannina
Greece General Hospital Komotinis Komotini
Greece General University Hospital of Larissa Larissa
Greece University of Patras Medical School Patras
Greece General Hospital of Rhodes Rhodes
Greece "Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo Thessaloniki
Greece Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic Thessaloniki
Greece General Panarkadiko Hospital of Tripolis, Cardiology Clinic Tripoli
Ireland Portiuncula Hospital Ballinasloe
Ireland Adelaide & Meath Hospital Dublin
Ireland St James's Hospital Dublin 8
Ireland University Hospital Galway Galway
Ireland The Redhouse Family Practice Mallow
Italy Ospedale Riuniti Albano Genzano Albano Laziale
Italy Az. Osp. S.M. di Misericordia Albenga
Italy Az. Ospedaliere Umberto I di Ancona Ancona
Italy Ospedale Reg Umberto Parini Aosta
Italy Ospedale C. G. Mazzoni Ascoli Piceno
Italy AZ. Osp. Assisi U.O. Assisi
Italy Osp. SS Filippo Nicola Avezzano
Italy Policlinico di Bari Bari
Italy Policlinico Universitario di Bari Bari
Italy Policlinico S. Orsola Malpighi Bologna
Italy A. O. G. Brotzu Cagliari
Italy Presidio Ospedaliero di Castrovillari Castrovillari (CS)
Italy A.O. Univ. Vittorio Ferrarotto S. Bambino Catania
Italy P. O. "Garibaldi" - Nesima Catania
Italy Policlinico Universitario Mater Domini, Universita di Catanzaro Catanzaro
Italy Osp. Clin. SS. Anunziata Chieti
Italy Azienda Ospedaliera Universitaria Arcispedale Sant'Anna Cona (FE)
Italy Osp.S.Salvatore Coppitto (AQ)
Italy AZ. Osped. Ospedale Maggiore di Crema Crema (CR)
Italy A. Istituti Osp. di Cremona Cremona
Italy Ospedale S. Biagio Domodossola (VB)
Italy Azienda Ospedaliera Careggi Firenze
Italy Azienda Ospedaliera Careggi Firenze
Italy P. O. S. Maria Nuova Firenze
Italy Az.Osp. Universitaria "Ospedali Riuniti" Foggia
Italy Ospedale S. Cuore di Gesù Gallipoli
Italy Policlinico San Martino Genova
Italy Ospedale della Misericordia Grosseto
Italy Ospedale F. Veneziale Isernia
Italy Azienda Ospedaliera C. Poma Mantova
Italy Osp. Pediatrico Aprano Pasquinucci Massa
Italy Az Osp. Amico " Gaetano Fucito" Mercato San Severino (SA)
Italy Centro Cardiologico Monzino-IRCCS Milano
Italy Nuovo Ospedale Civile S. Agostino-Estense Modena
Italy Osp.Riun.Valdichiana Senese Montepulciano Senese (SI)
Italy A.O. San Gerardo di Monza Monza (MB)
Italy Ospedale Cardarelli Napoli
Italy Ospedale Nuovo Pellegrini Napoli
Italy Osp.Sacro Cuore-Don Calabria Negrar (VR)
Italy Az. Osp. San Giacomo Novi Ligure
Italy Az. Osp. San Francesco Nuoro
Italy Azienda Sanitaria Ospedale S. Luigi Gonzaga Orbassano (TO)
Italy Azienda Ospedaliera Universitaria di Padova Padova
Italy A.O. Univ. Policlinico Giaccone Palermo
Italy Fondazione IRCCS Policlinico S. Matteo Pavia
Italy Ospedale S.Maria della Misericordia, AO di Perugia Perugia
Italy Ospedale San Salvatore Pesaro
Italy Osp. Guglielmo da Saliceto AUSL di Piacenza Piacenza
Italy Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese Pietra Ligure
Italy Ospedale di Cisanello Pisa
Italy Ospedale S.Tommaso dei Battuti Portogruaro (VE)
Italy P.O.S. Maria Grazie Pozzuoli
Italy Azienda Unità Sanitaria Locale di Reggio Emilia Reggio Emilia
Italy A.O. San Camillo Forlanini Roma
Italy Az. Osp. S.Giovanni-Addolorata Roma
Italy Az. Osp.Madre Giuseppina Vannini- Roma
Italy Azienda Complessa Ospedaliera Ospedale San Fiippo Neri Roma
Italy Ospedale "Giambattista Grassi Roma
Italy Ospedale "S. Eugenio" Roma
Italy Ospedale S. Spirito Roma
Italy Pol. Universitario Tor Vergata Roma
Italy Policlinico Casilino U.O. Cardiologia Roma
Italy Policlinico Gemelli Roma
Italy Umberto I Pol. di Roma-Università di Roma La Sapienza Roma
Italy Nuovo Ospedale Civile di Sassuolo Sassuolo
Italy IRCCS Gruppo Multimedica Sesto S.Giovanni (MI)
Italy A.O.U. Senese Policlinico Santa Maria alle Scotte Siena
Italy AO Città della Salute e della Torino
Italy Ospedale Mauriziano di Torino Torino
Italy Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO Treviso
Italy A. O. S. Maria della Misericordia Udine
Italy A. O. Ospedale Circolo Fond. Macchi Varese
Italy Ospedale San Bortolo Vicenza
Latvia Liepaja Regional Hospital, Therapy Department Liepaja
Latvia P.Stradins Clin.Univ.Hosp,Cardio.Diagnos&Outpatient Dep,Riga Riga
Latvia Riga East University Hospital Riga
Netherlands Jeroen Bosch Ziekenhuis-Hertogenbosch 's HERTOGENBOSCH
Netherlands Amsterdam UMC, Locatie AMC Amsterdam
Netherlands Rijnstate Hospital Arnhem
Netherlands IJsselland Ziekenhuis Capelle Aan Den Ijssel
Netherlands Reinier de Graaf Groep Delft
Netherlands Noordwest Ziekenhuisgroep Den Helder
Netherlands Deventer Ziekenhuis Deventer
Netherlands Van Weel-Bethesda Ziekenhuis Dirksland
Netherlands Catharina Ziekenhuis Eindhoven
Netherlands Medisch Spectrum Twente Enschede
Netherlands Zuyderland Medisch Centrum Heerlen
Netherlands TREANT zorggroep Hoogeveen
Netherlands Westfries Gasthuis Hoorn
Netherlands METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht Maastricht
Netherlands St. Antonius ziekenhuis, locatie Nieuwegein Nieuwegein
Netherlands Havenziekenhuis Rotterdam
Netherlands Zuyderland Medisch Centrum Sittard - Geleen
Netherlands Antonius Ziekenhuis Sneek
Netherlands Ziekenhuis Rivierenland Tiel
Netherlands VieCuri Medisch Centrum, locatie Venray Venray
Netherlands Isala Zwolle Zwolle
Norway Legegruppen Arendal Arendal
Norway Vestre Viken HF, Bærum sykehus Drammen
Norway Medisinsk Senter Fornebu DA Fornebu
Norway Vestre Viken, Ringerike Sykehus HF Hønefoss
Norway Sykehuset Innlandet HF, Kongsvinger Kongsvinger
Norway Sykehuset Innlandet HF, Avd. Lillehammer Lillehammer
Norway Volvat Medisinske senter, Oslo Oslo
Norway Universitetssykehuset Nord-Norge, Tromsø Tromsø
Poland Univ. Clinic Hosp, Bialystok Bialystok
Poland Private Practice Jacek Kowalczyk, Bytom Bytom
Poland Specialist Out-patient Clinics 'Na Gornej',Cieszyn Cieszyn
Poland Specialistic Cardiology&Hypertension Out-patient Clin,Kielce Kielce
Poland Private Practice of Heart Diseases Malgorzata Lelonek,Lodz Lodz
Poland Allmedica Sp. z.o.o, prac. Nowy Targ Nowy Targ
Poland Private Specialistic Practices, Nysa Nysa
Poland Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno Opoczno
Poland Szpital Specjalistyczny w Pulawach Pulawy
Poland Cardiology Out-patient Clinic "Cardio-Plus", Radlin Radlin
Poland Internal Medicine,Cardiol.practiceWanda&Jerzy Sudnik,Sokolka Sokolka
Poland Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin Szczecin
Poland Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze Zabrze
Poland Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze Zabrze
Portugal Hospital Garcia de Orta, EPE Almada
Portugal CHLO, EPE - Hospital de Santa Cruz Carnaxide
Portugal Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã Covilhã
Portugal Hospital do Espírito Santo, EPE Évora
Portugal Centro Hospitalar Algarve, EPE Faro
Portugal CHLO, EPE - Hospital S. Francisco Xavier Lisboa
Portugal CHULN, EPE - Hospital de Santa Maria Lisboa
Portugal CHULN, EPE - Hospital de Santa Maria Lisboa
Portugal Hospital da Luz Lisboa
Portugal Centro Hospitalar Universitário São João,EPE Porto
Portugal Hospital de Santiago Setúbal
Romania CMI Dr. Bogdan Minescu, Braila Braila
Romania Emergency University Hospital, Bucharest Bucharest
Romania Humanitas Medical Center, Bucharest Bucharest
Romania ILRO Medical SRL, Bucharest Bucharest
Romania Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest Bucharest
Romania SC Titan Medical SRL, Bucharest Bucharest
Romania SC Cardiomed SRL, Cluj Napoca Cluj Napoca
Romania SC Cardiomed SRL, Constanta Constanta
Romania S.C Cardiomed S.R.L Craiova
Romania SC Cardiomed SRL, Iasi Iasi
Romania Galenus Medical Center, Targu Mures Targu Mures
Romania Medicorclinics, Timisoara Timisoara
Slovenia General Hospital Celje Celje
Slovenia Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases Ljubljana
Spain Hospital A Coruña A Coruña
Spain CAP Passeig de Maragall Barcelona
Spain Hospital Clínic de Barcelona Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital Vall d'Hebron Barcelona
Spain Hospital La Princesa Cáceres
Spain Consultorio Cañaveral Cañaveral (Cáceres)
Spain Hospital Santa Lucía Cartagena (Murcia)
Spain Hospital Universitario Reina Sofía Córdoba
Spain Hospital Universitario Virgen de la Arrixaca El Palmar - Murcia
Spain Hospital Universitario San Cecilio Granada
Spain Hospital Jerez de la Frontera Jerez De La Frontera - Cádiz
Spain Hospital de Gran Canaria Dr. Negrín Las Palmas de Gran Canaria
Spain Hospital Severo Ochoa Leganes - Madrid
Spain Hospital de León Leon
Spain Hospital de León León
Spain Hospital Universitario Lucus Augusti Lugo
Spain Centro de Salud Isla de Oza Madrid
Spain Centro de Salud Jazmin Madrid
Spain Fundación Jiménez Díaz Madrid
Spain Hospital La Paz Madrid
Spain Hospital Ramón y Cajal Madrid
Spain Hospital Regional Universitario de Málaga Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Hospital Virgen de la Victoria Malaga
Spain Hospital Costa del Sol Marbella . Málaga
Spain Hospital de Son Llàtzer Palma de Mallorca
Spain Complejo Hospitalario de Navarra Pamplona
Spain Hospital General Universitario de Alicante San Juan de Alicante
Spain Hospital Moises Broggi Sant Joan Despi
Spain Hospital Universitario Marqués de Valdecilla Santander
Spain Hospital Clínico de Santiago Santiago de Compostela
Spain ABP Salud Sevilla Sevilla
Spain Hospital Nuestra Señora de Valme Sevilla
Spain Hospital San Juan de Dios Sevilla
Spain Hospital Virgen del Rocío Sevilla
Spain CS Ingeniero Joaquin Benlloch Valencia
Spain Hospital Arnau de Vilanova Valencia
Spain Hospital Dr. Peset Valencia
Spain Hospital General Universitario de Valencia Valencia
Spain Hospital Univ La Fe Valencia
Spain Hospital Comarcal Axarquía Vélez-Málaga
Spain Hospital Meixoeiro Vigo
Spain Hospital Povisa Vigo
Sweden Falu lasarett Falun
Sweden Sahlgrenska Universitetssjukhuset, Östra Göteborg
Sweden Skånes universitetssjukhus, Malmö Malmö
Sweden Danderyds Sjukhus Stockholm
Sweden Stockholm Heart Center AB Stockholm
Sweden Norrlands Universitetssjukhus Umeå
Sweden Centrallasarettet, Västerås Västerås
United Kingdom Gale Farm Surgery Acomb
United Kingdom William Harvey Hospital Ashford
United Kingdom Axbridge and Wedmore Medical Practice Axbridge
United Kingdom Basildon University Hospital Basildon
United Kingdom North Hampshire Hospital Basingstoke
United Kingdom Beehive Surgery Bath
United Kingdom Royal United Hospital Bath
United Kingdom Birmingham City Hospital Birmingham
United Kingdom Royal Bournemouth and Christchurch Hospital Bournemouth
United Kingdom Bradford on Avon Health Centre Bradford on Avon
United Kingdom Bradgate Surgery Bristol
United Kingdom Bristol Royal Infirmary Bristol
United Kingdom Clevedon Riverside Group Bristol
United Kingdom Southmead Hospital Bristol
United Kingdom Burbage Surgery Burbage, Hinkley
United Kingdom West Suffolk Hospital Bury St Edmunds
United Kingdom Cumberland Infirmary Carlisle
United Kingdom Countess of Chester Hospital Chester
United Kingdom Castle Hill Hopsital Cottingham
United Kingdom Pound Hill Medical Group Crawley
United Kingdom Dorset County Hospital Dorchester
United Kingdom Russells Hall Hospital Dudley
United Kingdom Ninewells Hospital & Medical School Dundee
United Kingdom University Hospital of North Durham Durham
United Kingdom Royal Devon and Exeter Hospital Exeter
United Kingdom Gloucestershire Royal Hospital Gloucester
United Kingdom The County Hospital Hereford
United Kingdom Wycombe General Hospital High Wycombe
United Kingdom Honiton Surgery Group - Seamark Honiton
United Kingdom Hedon Group Practice Hull
United Kingdom Airedale General Hospital Keighley
United Kingdom Westmorland General Hospital Kendal
United Kingdom Sherbourne Medical Centre Leamington Spa
United Kingdom Leeds General Infirmary Leeds
United Kingdom Aintree University Hospital Liverpool
United Kingdom Research Unit, Liverpool Heart and Chest Hospital Liverpool
United Kingdom St George's Hospital London
United Kingdom University Hospital Lewisham London
United Kingdom Altnagelvin Area Hospital Londonderry
United Kingdom Luton and Dunstable University Hospital Luton
United Kingdom St Chad's Surgery Midsomer Norton
United Kingdom Northampton General Hospital Northampton
United Kingdom Norfolk and Norwich University Hospital Norwich
United Kingdom George Eliot Hospital Nuneaton
United Kingdom Royal Oldham Hospital Oldham
United Kingdom Perth Royal Infirmary Perth
United Kingdom Peterborough City Hospital Peterborough
United Kingdom Derriford Hospital Plymouth
United Kingdom Poole Hospital Poole
United Kingdom Craigavon Area Hospital Portadown, County Atrim
United Kingdom Royal Preston Hospital Preston
United Kingdom Royal Berkshire Hospital Reading
United Kingdom Alexandra Hospital Redditch
United Kingdom Cape Cornwall Surgery Saint Just, Penzance
United Kingdom Salisbury District Hospital Salisbury
United Kingdom Royal Shrewsbury Hospital Shrewsbury
United Kingdom Wexham Park Hospital Slough
United Kingdom The Conquest Hospital St Leonards on Sea
United Kingdom County Hospital Stafford
United Kingdom Branch End Surgery Stocksfield
United Kingdom Royal Stoke University Hospital Stoke-on-Trent
United Kingdom Sunderland Royal Hospital Sunderland
United Kingdom King's Mill Hospital Sutton in Ashfield
United Kingdom Singleton Hospital Swansea
United Kingdom Musgrove Park Hospital Taunton
United Kingdom Torbay Hospital Torquay
United Kingdom South Tyneside District Hospital Tyne-and-Wear
United Kingdom Hillingdon Hospital Uxbridge
United Kingdom Wansford Surgery Wansford, Peterborough
United Kingdom The Avenue Surgery Warminster
United Kingdom Warwick Hospital Warwick
United Kingdom Queen Elizabeth II Hospital Welwyn Garden City
United Kingdom Westbury Group Practice Westbury
United Kingdom Southend General Hospital Westcliffe-on-Sea
United Kingdom Whitby Group Practice Whitby
United Kingdom Arrowe Park Hospital Wirral
United Kingdom New Cross Hospital Wolverhampton
United Kingdom Jorvik Medical Practice York
United Kingdom MyHealth, Strensall Health Care Centre York
United Kingdom The York Hospital York
United Kingdom York Medical Group York

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

Austria,  Belgium,  Bulgaria,  Croatia,  Czechia,  Denmark,  Estonia,  France,  Germany,  Greece,  Ireland,  Italy,  Latvia,  Netherlands,  Norway,  Poland,  Portugal,  Romania,  Slovenia,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) Incidence rate of composite outcome which includes events of Stroke, systemic embolism, myocardial infarction, life-threatening bleeding events and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) Incidence rate of vascular composite outcome including events of stroke, systemic embolism, myocardial infarction and vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. In case of multiple events for a patient, the first event was considered. Unknown death was imputed by multiple imputation. The average of the 20 incidence rates from the 20 imputed datasets were used to obtain the point estimate of the incidence rate that is reported here. The bootstrapping approach was used to obtain the 95% confidence interval of the incidence rate. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Stroke or Systemic Embolism Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Stroke Incidence rate of stroke on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Stroke is an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke included ischemic or hemorrhagic or uncertain classification. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Transient Ischaemic Attack (TIA) Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Systemic Embolism (SEE) Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Pulmonary Embolism (PE) Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Major Bleeding Events Incidence rate of major bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Major bleeding was defined as meeting one or more of the following criteria: Overt bleeding associated with a reduction in haemoglobin of at least 20 grams per liter or leading to a transfusion of at least 2 units of blood or packed cells; Symptomatic bleeding in a critical area or organ: Intraocular, intracranial, intraspinal or intramuscular with compartment syndrome, retroperitoneal bleeding, intra-articular bleeding or pericardial bleeding; Life-threatening bleeding. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Life-threatening Bleeding Events Incidence rate of life-threatening bleeding events on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. Life-threatening bleeding was defined as meeting one or more of the following criteria: Symptomatic intracranial bleed; Reduction in haemoglobin of at least 50 grams per liter; Transfusion of at least 4 units of blood or packed cells, associated with hypotension requiring the use of intravenous inotropic agents; Necessitated surgical intervention; Fatal bleeding. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Vascular Death Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of Myocardial Infarction Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
Primary Incidence Rate of All-cause Death Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only. From baseline visit until end of initial treatment regimen episode (minimum date of permanent stop of DE + 3 days/ VKA+ 6 days, start date of other treatments - 1 day, and date of study completion/discontinuation), up to 3 years.
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