GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

December 7, 2020 updated by: Boehringer Ingelheim

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

10471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Austria
- - Bad Pirawarth, Austria, 2222
    - Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth
  - Linz, Austria, 4021
    - Kepler Univ. Klinikum Linz
  - Linz, Austria, 4010
    - KH der Barmherzigen Schwestern Linz
  - Oberwart, Austria, 7400
    - Ordination Dr. Martin Koschutnik, Oberwart
  - Wien, Austria, 1090
    - AKH - Medical University of Vienna
  - Wien, Austria, 1020
    - KH d. Barmherzigen Brüder Wien, Neurologie
Belgium
- - Bouge/Namur, Belgium, 5004
    - Namur - HOSP St-Luc de Bouge
  - Brugge, Belgium, 8310
    - AZ Sint-Lucas
  - Brussel, Belgium, 1180
    - Brussels - HOSP Europe (Ste-Elisabeth)
  - Brussel, Belgium, 1000
    - Brussels - HOSP St-Jan
  - Bruxelles, Belgium, 1070
    - ULB Hôpital Erasme
  - Genk, Belgium, 3600
    - Ziekenhuis Oost-Limburg - Campus Sint-Jan
  - Liège, Belgium, 4000
    - Liège - HOSP CHR de la Citadelle
  - Ottignies, Belgium, 1340
    - Ottignies - HOSP St-Pierre
  - Tienen, Belgium, 3300
    - Tienen - PRAC De Wolf, Luc
Bulgaria
- - Burgas, Bulgaria, 5800
    - MHAT "Deva Maria", Dept. of Cardiology, Burgas
  - Kazanlak, Bulgaria, 6100
    - MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak
  - Plovdiv, Bulgaria, 4002
    - UMHAT Sv.Georgi EAD
  - Rousse, Bulgaria, 7002
    - MHAT, Fourth Dept. of Internal Medicine, Rousse
  - Sevlievo, Bulgaria, 5400
    - MHAT Akta Medika OOD, Sevlievo
  - Sliven, Bulgaria, 8800
    - Multiprofile Hospital for Active Treatment, Sliven
  - Sofia, Bulgaria, 1431
    - University Multiprofile Hospital 'Alexandrovska', Sofia
  - Sofia, Bulgaria, 1202
    - Diagnostic & Consultancy Center "Ascendent", Sofia
  - Sofia, Bulgaria, 1309
    - MHAT "National Cardiology Hosp." Cardiology Dept., Sofia
  - Sofia, Bulgaria, 1505
    - MHAT, "Vita" Surgery Department, Sofia
  - Sofia, Bulgaria, 1527
    - MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia
  - Stara Zagora, Bulgaria, 6003
    - UMHAT, Clinic of Cardiology, Stara Zagora
  - Varna, Bulgaria, 9010
    - Medical Military Academy MHAT Varna
  - Yambol, Bulgaria, 8600
    - Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
Croatia
- - Krapinske Toplice, Croatia, 49217
    - Magdalena-Special Hosp.f.Cardiovas.Surgery,Krapinske Toplice
  - Opatija, Croatia, 51410
    - Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija
  - Split, Croatia, 21000
    - Clinical Hospital Split
  - Zadar, Croatia, 23 000
    - General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept
  - Zagreb, Croatia, 10000
    - University hospital center Zagreb
  - Zagreb, Croatia, 10 000
    - University hospital center Zagreb
  - Zagreb, Croatia, 100 00
    - Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb
  - Zagreb, Croatia, 10 000
    - Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
  - Zagreb, Croatia, 10 000
    - Polyclinic St. Luke, Cardiology Dept., Zagreb
  - Zagreb, Croatia, 10 000
    - Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb
Czechia
- - Brno, Czechia, 625 00
    - University Hospital Brno
  - Brno, Czechia, 61600
    - Cardiology Private Practice, Brno
  - Kladno, Czechia, 272 80
    - Cardiocentrum, Private Practice, Kladno
  - Litovel, Czechia, 784 01
    - Cardiology Private Practice
  - Praha 5, Czechia, 15005
    - Cardiology Private Practice, Praha
  - Roznov pod Radhostem, Czechia, 756 61
    - Cardiology Private Practice, Roznov pod Radhostem
Denmark
- - Aalborg, Denmark, 9000
    - Forskningens Hus
  - Esbjerg, Denmark, 6700
    - Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd.
  - Herlev, Denmark, 2730
    - Herlev and Gentofte Hospital
  - Hillerød, Denmark, 3400
    - Nordsjællands Hospital - Hillerød
  - Kolding, Denmark, 6000
    - Kolding Sygehus
  - Odense, Denmark, 5000
    - Odense University Hospital
Estonia
- - Tallin, Estonia, 10138
    - East Tallinn Central Hospital
  - Tallinn, Estonia, 134 19
    - North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin
France
- - Abbeville, France, 80142
    - HOP Général, Cardio, Abbeville
  - Agen, France, 47923
    - HOP d'Agen, Cardio, Agen
  - Aix en Provence, France, 13616
    - HOP d'Aix en Provence, cardio, Aix-en-Provence
  - Aix en Provence, France, 13616
    - HOP Général, Cardio, Abbeville
  - Bagnols sur Ceze, France, 30205
    - HOP Louis Pasteur, Cardio, Bagnols sur Ceze
  - Bar le Duc, France, 55012
    - HOP Bar le Duc, Pneumo, Bar le Duc
  - Bayonne, France, 64109
    - HOP de Bayonne
  - Besancon, France, 25030
    - HOP Jean Minjoz
  - Beziers, France, 34500
    - CAB Berdagué P, Cardio, Beziers
  - Beziers, France, 34500
    - CAB Breton Dr Nicolas
  - Bordeaux, France, 33000
    - CLI Tivoli
  - Bordeaux, France, 33075
    - HOP Saint-André
  - Boulogne-Billancourt, France, 92104
    - HOP Ambroise Paré
  - Bour-en-Bresse, France, 01012
    - HOP Fleyriat, GERIA, Bourg-en-Bresse
  - Brest, France, 29609
    - HOP de la Cavale Blanche
  - Brive La Gaillarde, France, 19100
    - CLI les Cedres, Cardio, Brive La Gaillarde
  - Broglie, France, 27270
    - CAB Cadinot Dr D, Broglie
  - Bruay la Buissière, France, 62700
    - CAB Frappé T, MG, BRUAY LA BUISSIERE
  - Béziers, France, 34525
    - HOP de Béziers
  - Caen, France, 14033
    - HOP Côte de Nacre
  - Caen, France, 14000
    - HOP Saint Martin, cardio, Caen
  - Cannes, France, 06400
    - CAB Brunschwig, Cardio, Cannes
  - Chalon-Sur-Saône, France, 71100
    - HOP William Morey, Cardio, Chalon-Sur-Saône
  - Cherbourg, France, 50100
    - CAB Loiselet P
  - Clermont Ferrand, France, 63000
    - HOP Gabriel-Montpied
  - Clermont Ferrand, France, 63100
    - CAB Brunehaut M, Cardio, Clermont Ferrand
  - Corbeil Essonnes, France, 91106
    - HOP Sud Francilien
  - Corbeil-Essonnes, France, 91106
    - HOP Sud Francilien, Cardio, Corbeil-Essonnes
  - Creteil, France, 94000
    - HOP Henri Mondor
  - Dijon, France, 21079
    - HOP Bocage
  - Dole, France, 39108
    - HOP Louis Pasteur, Cardio, Dole
  - Evecquemont, France, 78740
    - CTRE Evecquemont, Cardio, Evecquemont
  - Foix, France, 09107
    - HOP du Val d'Ariège, Cardio, Foix
  - La Tronche, France, 38700
    - HOP Michallon
  - Le Bourget, France, 93350
    - CAB Benhalima B, Cardio, Le bourget
  - Le Chesnay, France, 78150
    - HOP André Mignot
  - Le Coudray, France, 28630
    - HOP Louis Pasteur, Cardio, Le Coudray
  - Le Mans, France, 72037
    - HOP Le Mans
  - Levallois Perret, France, 92300
    - CAB Phan Cao Phai, Cardio, Levallois Perret
  - Libourne, France, 33500
    - CLI Libournais, Cardio, Libourne
  - Libourne, France, 33500
    - HOP Robert Boulin, cardio, Libourne
  - Lille, France, 59000
    - CLI de la Louviere
  - Limoges, France, 87100
    - CLI le Colombier, Cardio, Limoges
  - Lyon cedex 7, France, 69365
    - HOP St Joseph-St Luc, Cardio, Lyon
  - Maisons Alfort, France, 94700
    - CAB Gartenlaub O, Cardio, Maison Alfort
  - Marseille, France, 13001
    - CAB, Salem A, Cardio, Marseille
  - Marseille, France, 13003
    - HOP Européen
  - Marseille, France, 13008
    - CAB Scala P-J
  - Marseille, France, 13008
    - CAB Scemama J
  - Marseille, France, 13009
    - CAB vial, Cardio, Marseille
  - Marseille cedex 5, France, 13385
    - HOP Timone
  - Martigues, France, 13698
    - HOP des Rayettes
  - Metz-Tessy, France, 74370
    - HOP de la région d'Annecy, Cardio, Metz-Tessy
  - Mondelange, France, 57300
    - CAB Dillinger J, MG, Mondelange
  - Montargis, France, 45200
    - CLI de Montargis, Cardio, Montargis
  - Montauban, France, 82000
    - CLI du Pont de Chaume
  - Montfermeil, France, 93370
    - HOP Raincy Montfermeil, Cardio, Montfermeil
  - Montpellier, France, 34295
    - HOP Arnaud de Villeneuve
  - Montreuil, France, 93100
    - CAB Prunier L, Cardio, Montreuil
  - Nancy, France, 54035
    - HOP Central, Neuro, Nancy
  - Neuilly sur Seine, France, 92200
    - HOP de Courbevoie, Spécialités Med, Neuilly sur Seine
  - Nimes, France, 30000
    - CAB Jamon Y, Cardio, Nîmes
  - Nîmes, France, 3000
    - HOP Carémeau
  - Nïmes, France, 30032
    - CLI Les Franciscaines, cardio, Nïmes
  - Orléans, France, 45100
    - HOP Orléans, Cardio, Orléans
  - Paris, France, 75015
    - HOP Européen G. Pompidou
  - Paris, France, 75007
    - CAB Audouin P, Cardio, Paris
  - Paris, France, 75008
    - CLI Turin, Cardio, Paris
  - Paris, France, 75012
    - CAB Cohen S, Paris
  - Paris, France, 75014
    - CAB Poulain F, Paris
  - Rennes Cedex, France, 35033
    - HOP Pontchaillou
  - Rouen, France, 76000
    - CAB Duvilla N, Cardio, Rouen
  - Saint André lez Lille, France, 59350
    - CAB Dascotte O, Cardio, St André lez Lille
  - Saint Benoit, France, 86280
    - CAB Lequeux B, Cardio, Saint Benoit
  - Saint Etienne, France, 42000
    - HOP Privé de la Loire, Cardio, Saint Etienne
  - Saint-Yrieix-la-Perche, France, 87500
    - CAB Dary P, Cardio, St-Yrieix-la-Perche
  - St Raphael, France, 83700
    - CAB Tessier P, Cardio, St Raphael
  - Strasbourg, France, 67000
    - CAB Muller J-J, Cardio, Strasbourg
  - Tarbes, France, 65000
    - CLI de l'Ormeau, Cardio, Tarbes
  - Thionville, France, 57100
    - CAB Houppe Nousse MP, Cardio, Thionville
  - Thonon-les-bains, France, 74203
    - HOP du Léman
  - Toulon, France, 83100
    - HOP Sainte Musse
  - Toulouse, France, 31059
    - HOP Rangueil
  - Tourcoing, France, 59200
    - HOP Cardio, Tourcoing
  - Tours, France, 37000
    - CAB Leprince P, MG, Tours
  - Tours, France, 37044
    - HOP Trousseau
  - Trelaze, France, 49804
    - CLI Village de Santé, Cardio, Trélaze
  - Valence, France, 26000
    - HOP Valence, Cardio, Valence
  - Vannes, France, 56017
    - HOP Bretagne Atlantique, Cardio, Vannes
  - Vieux Condé, France, 59690
    - CAB Lejay D, MG, Vieux Condé
  - Vihiers, France, 49310
    - CAB Schaupp T, MG, Vihiers
Germany
- - Ansbach, Germany, 91522
    - Bezirkskrankenhaus, Ansbach
  - Bad Nauheim, Germany, 61231
    - Kerckhoff-Klinik, Bad Nauheim
  - Bad Neustadt/Saale, Germany, 97616
    - Neurologische Klinik GmbH, Bad Neustadt
  - Bamberg, Germany, 96046
    - Sozialstiftung Bamberg
  - Berlin, Germany, 12351
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 12203
    - Charite - Universitätsmedizin Berlin
  - Berlin, Germany, 10967
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 10789
    - Praxis Dr. Rieker, Berlin
  - Berlin, Germany, 10785
    - Evangelisches Elisabeth-Krankenhaus, Berlin Mitte
  - Berlin, Germany, 12489
    - Praxis Dr. Altmann, Berlin
  - Berlin, Germany, 12555
    - Praxisgemeinschaft Dres. Weinrich
  - Berlin, Germany, 12559
    - Praxis Dr. Claus, 10969 Berlin
  - Berlin, Germany, 13405
    - Kardiologische Praxis Dr. Jochen Bott
  - Berlin, Germany, 13505
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 13509
    - Vivantes Netzwerk für Gesundheit GmbH
  - Berlin, Germany, 13585
    - Vivantes Netzwerk für Gesundheit GmbH
  - Bochum, Germany, 44791
    - Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
  - Bremen, Germany, 28177
    - Gesundheit Nord gGmbH | Klinikverbund Bremen
  - Bremerhaven, Germany, 27574
    - Klinikum Bremerhaven
  - Celle, Germany, 29221
    - Herz- und Gefaesszentrum am Neumarkt
  - Chemnitz, Germany, 09116
    - Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz
  - Coburg, Germany, 96450
    - Klinikum Coburg gGmbH
  - Dachau, Germany, 85221
    - HELIOS Amper Kliniken, Dachau
  - Darmstadt, Germany, 64287
    - Kardiologische Praxisgemeinschaft,Darmstadt
  - Dessau-Roßlau, Germany, 06847
    - Praxis Dr. Rybak, Dessau
  - Detmold, Germany, 32756
    - Klinikum Lippe-Detmold GmbH
  - Dinslaken, Germany, 46535
    - Kardiologischen Gemeinschaftspraxis Dinslaken
  - Dortmund, Germany, 44147
    - Praxis Dr. med. Bernhard-Paul Lodde
  - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus Dresden
  - Dresden, Germany, 01099
    - Praxisklinik Herz und Gefäße
  - Düsseldorf, Germany, 40217
    - Evangelisches Krankenhaus Düsseldorf
  - Erlangen, Germany, 91054
    - Universitätsklinikum Erlangen
  - Essen, Germany, 45122
    - Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
  - Esslingen, Germany, 73730
    - Klinikum Esslingen GmbH
  - Greiz, Germany, 07973
    - Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz
  - Hamburg, Germany, 20246
    - Universitätsklinikum Hamburg-Eppendorf
  - Hamburg, Germany, 22291
    - Asklepios Klinik Barmbek
  - Hamburg, Germany, 21075
    - Asklepios Klinik Harburg
  - Hamburg, Germany, 20099
    - Asklepios Klinik St. Geort
  - Hannover, Germany, 30159
    - Praxis Herz im Zentrum Laske
  - Heidelberg, Germany, 69120
    - Universitätsklinikum Heidelberg
  - Ingolstadt, Germany, 85049
    - Klinikum Ingolstadt GmbH
  - Itzehoe, Germany, 25524
    - Praxis Dr. Mibach, Itzehoe
  - Jena, Germany, 07740
    - Universitätsklinikum Jena
  - Kassel, Germany, 34117
    - Kardiologische Gemeinschaftspraxis Kassel
  - Kempen, Germany, 47906
    - Praxis Dr. med. Frickel Siegfried
  - Kirchzarten, Germany, 79199
    - Praxis Dr. med. Matthias Gabelmann
  - Kleve, Germany, 47533
    - St. Antonius-Hospital, Kleve
  - Köln, Germany, 51105
    - Praxis für Kardiologie, Köln
  - Leipzig, Germany, 04103
    - Universitätsklinikum Leipzig
  - Leipzig, Germany, 04289
    - Herzzentrum Leipzig GmbH
  - Leverkusen, Germany, 51375
    - Klinikum Leverkusen gGmbH, Leverkusen
  - Ludwigsburg, Germany, 71634
    - Cardio Centrum Ludwigsburg
  - Ludwigshafen, Germany, 67063
    - Klinikum der Stadt Ludwigshafen am Rhein gGmbH
  - Magdeburg, Germany, 39120
    - Universitätsklinikum Magdeburg A. ö. R.
  - Mainz, Germany, 55116
    - Gemeinsachftspraxis Regner/Schmitt/Kros, Mainz
  - Markkleeberg, Germany, 04416
    - Praxis Dr.med. Jens Taggeselle, Markkleeberg
  - Memmingen, Germany, 87700
    - Klinikum Memmingen
  - Minden, Germany, 32429
    - Johannes Wesling Klinikum
  - Moenchengladbach, Germany, 41063
    - Kliniken Maria Hilf GmbH
  - Mühldorf, Germany, 84453
    - Praxis Dr. med. Norbert Schön, Mühldorf
  - München, Germany, 81675
    - Klinikum rechts der Isar der Technischen Universität München
  - München, Germany, 80331
    - Herzzentrum ALTER HOF München
  - Münster, Germany, 45129
    - Universitätsklinikum Münster
  - Nürnberg, Germany, 90402
    - Praxis Dr. med. Joachim Gmehling
  - Osnabrueck, Germany, 49076
    - Klinikum Osnabrück GmbH
  - Paderborn, Germany, 33098
    - St. Vincenz-Krankenhaus GmbH
  - Papenburg, Germany, 26871
    - Kardiologische Praxis Papenburg
  - Peine, Germany, 31224
    - Kardiologisches Zentrum Peine
  - Pforzheim, Germany, 75175
    - Städt. Krankenhaus, Pforzheim
  - Potsdam, Germany, 14471
    - Kardiologische Gemeinschaftspraxis Potsdam
  - Rostock, Germany, 18057
    - Kardiologische Gemeinschaftspraxis Rostock
  - Siegen, Germany, 57076
    - Kreisklinikum Siegen GmbH
  - Stuttgart, Germany, 70178
    - Berufsausübungsgemeinschaft Klein /Kratochvil
  - Ulm, Germany, 89077
    - Herzklinik Ulm Gemeinschaftspraxis
  - Villingen-Schwenningen, Germany, 78011
    - Schwarzwald-Baar Klinikum
  - Wermsdorf, Germany, 04779
    - Kardiologische Praxis, Wermsdorf
  - Wiesbaden, Germany, 65189
    - MedKonsil, Wiesbaden
  - Wittenberg, Germany, 06886
    - Kardiologische Gemeinschaftspraxis Wittenberg
  - Würzburg, Germany, 97080
    - Universitätsklinikum Würzburg
Greece
- - Alexandroupoli, Greece, 68100
    - University Hospital of Alexandroupolis
  - Athens, Greece, 11521
    - Euroclinic of Athens
  - Athens, Greece, 11526
    - "Korgialeneio-Benakeio" Hellenic Red Cross Hospital
  - Athens, Greece, 11527
    - Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med.
  - Athens, Greece, 16673
    - Asclepion Voulas Hospital, Cardiological Clinic
  - Chalkida, Greece, 34100
    - General Hospital of Chalkida
  - Chania, Greece, 73100
    - General Hospital of Chania
  - Edessa, Greece, 58200
    - General Hospital of Edessa, Cardiology Clinic
  - Elefsina, Greece, 19600
    - Gen. Hosp. of Elefsina "Thriassio"
  - Herakleion, Crete, Greece, 71110
    - University General Hospital of Heraklion
  - Ioannina, Greece, 45500
    - Univ. Gen. Hosp. of Ioannina
  - Komotini, Greece, 69100
    - General Hospital Komotinis
  - Larissa, Greece, 41110
    - General University Hospital Of Larissa
  - Patras, Greece, 26504
    - University of Patras Medical School
  - Rhodes, Greece, 85100
    - General Hospital of Rhodes
  - Thessaloniki, Greece, 54642
    - Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic
  - Thessaloniki, Greece, 56429
    - "Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo
  - Tripoli, Greece, 22100
    - General Panarkadiko Hospital of Tripolis, Cardiology Clinic
Ireland
- - Ballinasloe, Ireland, H53 T971
    - Portiuncula Hospital
  - Dublin, Ireland, 24
    - Adelaide & Meath Hospital
  - Dublin 8, Ireland, Dublin 8
    - St James's Hospital
  - Galway, Ireland, GALWAY
    - University Hospital Galway
  - Mallow, Ireland
    - The Redhouse Family Practice
Italy
- - Albano Laziale, Italy, 00041
    - Ospedale Riuniti Albano Genzano
  - Albenga, Italy, 17031
    - Az. Osp. S.M. di Misericordia
  - Ancona, Italy, 60020
    - Az. Ospedaliere Umberto I di Ancona
  - Aosta, Italy, 11100
    - Ospedale Reg Umberto Parini
  - Ascoli Piceno, Italy, 63100
    - Ospedale C. G. Mazzoni
  - Assisi, Italy, 06081
    - AZ. Osp. Assisi U.O.
  - Avezzano, Italy, 67051
    - Osp. SS Filippo Nicola
  - Bari, Italy, 70124
    - Policlinico di Bari
  - Bari, Italy, 70124
    - Policlinico Universitario di Bari
  - Bologna, Italy, 40138
    - Policlinico S. Orsola Malpighi
  - Cagliari, Italy, 09134
    - A. O. G. Brotzu
  - Castrovillari (CS), Italy, 87012
    - Presidio Ospedaliero di Castrovillari
  - Catania, Italy, 95122
    - P. O. "Garibaldi" - Nesima
  - Catania, Italy, 95124
    - A.O. Univ. Vittorio Ferrarotto S. Bambino
  - Catanzaro, Italy, 88100
    - Policlinico Universitario Mater Domini, Universita di Catanzaro
  - Chieti, Italy, 66013
    - Osp. Clin. SS. Anunziata
  - Cona (FE), Italy, 44124
    - Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
  - Coppitto (AQ), Italy, 67100
    - Osp.S.Salvatore
  - Crema (CR), Italy, 26013
    - AZ. Osped. Ospedale Maggiore di Crema
  - Cremona, Italy, 26100
    - A. Istituti Osp. di Cremona
  - Domodossola (VB), Italy, 28845
    - Ospedale S. Biagio
  - Firenze, Italy, 50139
    - Azienda Ospedaliera Careggi
  - Firenze, Italy, 50134
    - Azienda Ospedaliera Careggi
  - Firenze, Italy, 50122
    - P. O. S. Maria Nuova
  - Foggia, Italy, 71100
    - Az.Osp. Universitaria "Ospedali Riuniti"
  - Gallipoli, Italy, 73014
    - Ospedale S. Cuore di Gesù
  - Genova, Italy, 16132
    - Policlinico San Martino
  - Grosseto, Italy, 58100
    - Ospedale della Misericordia
  - Isernia, Italy, 86170
    - Ospedale F. Veneziale
  - Mantova, Italy, 46100
    - Azienda Ospedaliera C. Poma
  - Massa, Italy, 54100
    - Osp. Pediatrico Aprano Pasquinucci
  - Mercato San Severino (SA), Italy, 84085
    - Az Osp. Amico " Gaetano Fucito"
  - Milano, Italy, 20138
    - Centro Cardiologico Monzino-IRCCS
  - Modena, Italy, 46100
    - Nuovo Ospedale Civile S. Agostino-Estense
  - Montepulciano Senese (SI), Italy, 53045
    - Osp.Riun.Valdichiana Senese
  - Monza (MB), Italy, 20900
    - A.O. San Gerardo di Monza
  - Napoli, Italy, 80134
    - Ospedale Nuovo Pellegrini
  - Napoli, Italy, 80135
    - Ospedale Cardarelli
  - Negrar (VR), Italy, 37024
    - Osp.Sacro Cuore-Don Calabria
  - Novi Ligure, Italy, 15067
    - Az. Osp. San Giacomo
  - Nuoro, Italy, 08100
    - Az. Osp. San Francesco
  - Orbassano (TO), Italy, 10043
    - Azienda Sanitaria Ospedale S. Luigi Gonzaga
  - Padova, Italy, 35128
    - Azienda Ospedaliera Universitaria di Padova
  - Palermo, Italy, 90129
    - A.O. Univ. Policlinico Giaccone
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico S. Matteo
  - Perugia, Italy, 06156
    - Ospedale S.Maria della Misericordia, AO di Perugia
  - Pesaro, Italy, 6121
    - Ospedale San Salvatore
  - Piacenza, Italy, 29121
    - Osp. Guglielmo da Saliceto AUSL di Piacenza
  - Pietra Ligure, Italy, 17027
    - Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese
  - Pisa, Italy, 56124
    - Ospedale di Cisanello
  - Portogruaro (VE), Italy, 30026
    - Ospedale S.Tommaso dei Battuti
  - Pozzuoli, Italy, 80078
    - P.O.S. Maria Grazie
  - Reggio Emilia, Italy, 12100
    - Azienda Unita Sanitaria Locale di Reggio Emilia
  - Roma, Italy, 00168
    - Policlinico Gemelli
  - Roma, Italy, 00161
    - Umberto I Pol. di Roma-Università di Roma La Sapienza
  - Roma, Italy, 00133
    - Pol. Universitario Tor Vergata
  - Roma, Italy, 00184
    - Az. Osp. S.Giovanni-Addolorata
  - Roma, Italy, 00169
    - Policlinico Casilino U.O. Cardiologia
  - Roma, Italy, 00122
    - Ospedale "Giambattista Grassi
  - Roma, Italy, 00135
    - Azienda Complessa Ospedaliera Ospedale San Fiippo Neri
  - Roma, Italy, 00144
    - Ospedale "S. Eugenio"
  - Roma, Italy, 00151
    - A.O. San Camillo Forlanini
  - Roma, Italy, 00177
    - Az. Osp.Madre Giuseppina Vannini-
  - Roma, Italy, 00193
    - Ospedale S. Spirito
  - Sassuolo, Italy, 41049
    - Nuovo Ospedale Civile di Sassuolo
  - Sesto S.Giovanni (MI), Italy, 20090
    - IRCCS Gruppo Multimedica
  - Siena, Italy, 53100
    - A.O.U. Senese Policlinico Santa Maria alle Scotte
  - Torino, Italy, 10126
    - AO Città della Salute e della
  - Torino, Italy, 10128
    - Ospedale Mauriziano di Torino
  - Treviso, Italy, 31100
    - Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
  - Udine, Italy, 33100
    - A. O. S. Maria della Misericordia
  - Varese, Italy, 21100
    - A. O. Ospedale Circolo Fond. Macchi
  - Vicenza, Italy, 36100
    - Ospedale San Bortolo
Latvia
- - Liepaja, Latvia, 3414
    - Liepaja Regional Hospital, Therapy Department
  - Riga, Latvia, 1002
    - P.Stradins Clin.Univ.Hosp,Cardio.Diagnos&Outpatient Dep,Riga
  - Riga, Latvia, 1038
    - Riga East University Hospital
Netherlands
- - 's HERTOGENBOSCH, Netherlands, 5223 GZ
    - Jeroen Bosch Ziekenhuis-Hertogenbosch
  - Amsterdam, Netherlands, 1105 AZ
    - Amsterdam UMC, locatie AMC
  - Arnhem, Netherlands, 6815 AD
    - Rijnstate Hospital
  - Capelle Aan Den Ijssel, Netherlands, 2906 ZC
    - IJsselland Ziekenhuis
  - Delft, Netherlands, 2625 AD
    - Reinier de Graaf Groep
  - Den Helder, Netherlands, 1782 GZ
    - Noordwest ziekenhuisgroep
  - Deventer, Netherlands, 7416 SE
    - Deventer Ziekenhuis
  - Dirksland, Netherlands, 3247 BW
    - Van Weel-Bethesda Ziekenhuis
  - Eindhoven, Netherlands, 5623 EJ
    - Catharina Ziekenhuis
  - Enschede, Netherlands, 7512KZ
    - Medisch Spectrum Twente
  - Heerlen, Netherlands, 6419 PC
    - Zuyderland Medisch Centrum
  - Hoogeveen, Netherlands, 7909 AA
    - TREANT zorggroep
  - Hoorn, Netherlands, 1624 NP
    - Westfries Gasthuis
  - Maastricht, Netherlands, 6229 HX
    - METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
  - Nieuwegein, Netherlands, 3435 CM
    - St. Antonius Ziekenhuis, locatie Nieuwegein
  - Rotterdam, Netherlands, 3011 TD
    - Havenziekenhuis
  - Sittard - Geleen, Netherlands, 6162 BG
    - Zuyderland Medisch Centrum
  - Sneek, Netherlands, 8601 ZK
    - Antonius Ziekenhuis
  - Tiel, Netherlands, 4002 WP
    - Ziekenhuis Rivierenland
  - Venray, Netherlands, 5801 CE
    - VieCuri Medisch Centrum, locatie Venray
  - Zwolle, Netherlands, 8011 JW
    - Isala Zwolle
Norway
- - Arendal, Norway, N-4836
    - Legegruppen Arendal
  - Drammen, Norway, N-3004
    - Vestre Viken HF, Bærum Sykehus
  - Fornebu, Norway, N-1364
    - Medisinsk Senter Fornebu DA
  - Hønefoss, Norway, N-3511
    - Vestre Viken, Ringerike Sykehus HF
  - Kongsvinger, Norway, N-2212
    - Sykehuset Innlandet HF, Kongsvinger
  - Lillehammer, Norway, N-2629
    - Sykehuset Innlandet HF, Avd. Lillehammer
  - Oslo, Norway, N-0370
    - Volvat Medisinske senter, Oslo
  - Tromsø, Norway, N-9038
    - Universitetssykehuset Nord-Norge, Tromsø
Poland
- - Bialystok, Poland, 15276
    - Univ. Clinic Hosp, Bialystok
  - Bytom, Poland, 41902
    - Private Practice Jacek Kowalczyk, Bytom
  - Cieszyn, Poland, 43400
    - Specialist Out-patient Clinics 'Na Gornej',Cieszyn
  - Kielce, Poland, 25525
    - Specialistic Cardiology&Hypertension Out-patient Clin,Kielce
  - Lodz, Poland, 90727
    - Private Practice of Heart Diseases Malgorzata Lelonek,Lodz
  - Nowy Targ, Poland, 34400
    - Allmedica Sp. z.o.o, prac. Nowy Targ
  - Nysa, Poland, 48300
    - Private Specialistic Practices, Nysa
  - Opoczno, Poland, 26300
    - Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno
  - Pulawy, Poland, 24-100
    - Szpital Specjalistyczny w Pulawach
  - Radlin, Poland, 44144
    - Cardiology Out-patient Clinic "Cardio-Plus", Radlin
  - Sokolka, Poland, 16100
    - Internal Medicine,Cardiol.practiceWanda&Jerzy Sudnik,Sokolka
  - Szczecin, Poland
    - Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin
  - Zabrze, Poland, 41800
    - Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze
  - Zabrze, Poland, 41800
    - Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze
Portugal
- - Almada, Portugal, 2805-267
    - Hospital Garcia de Orta, EPE
  - Carnaxide, Portugal, 2799-523
    - CHLO, EPE - Hospital de Santa Cruz
  - Covilhã, Portugal, 6200-251
    - Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
  - Faro, Portugal, 8000-386
    - Centro Hospitalar Algarve, EPE
  - Lisboa, Portugal, 1500-650
    - Hospital da Luz
  - Lisboa, Portugal, 1449-005
    - CHLO, EPE - Hospital S. Francisco Xavier
  - Lisboa, Portugal, 1649-035
    - CHULN, EPE - Hospital de Santa Maria
  - Lisboa, Portugal, 1064-035
    - CHULN, EPE - Hospital de Santa Maria
  - Porto, Portugal, 4202-451
    - Centro Hospitalar Universitário São João,EPE
  - Setúbal, Portugal, 2900-722
    - Hospital de Santiago
  - Évora, Portugal, 7000-811
    - Hospital do Espirito Santo, EPE
Romania
- - Braila, Romania, 810262
    - CMI Dr. Bogdan Minescu, Braila
  - Bucharest, Romania, 050098
    - Emergency University Hospital, Bucharest
  - Bucharest, Romania, 10628
    - ILRO Medical SRL, Bucharest
  - Bucharest, Romania, 11792
    - Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest
  - Bucharest, Romania, 21323
    - SC Titan Medical SRL, Bucharest
  - Bucharest, Romania, 62272
    - Humanitas Medical Center, Bucharest
  - Cluj Napoca, Romania, 400015
    - SC Cardiomed SRL, Cluj Napoca
  - Constanta, Romania, 900704
    - SC Cardiomed SRL, Constanta
  - Craiova, Romania, 200147
    - S.C Cardiomed S.R.L
  - Iasi, Romania, 700034
    - SC Cardiomed SRL, Iasi
  - Targu Mures, Romania, 540099
    - Galenus Medical Center, Targu Mures
  - Timisoara, Romania, 300014
    - Medicorclinics, Timisoara
Slovenia
- - Celje, Slovenia, 3000
    - General Hospital Celje
  - Ljubljana, Slovenia, 1000
    - Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases
Spain
- - A Coruña, Spain, 15006
    - Hospital A Coruña
  - Barcelona, Spain, 08003
    - Hospital del Mar
  - Barcelona, Spain, 08036
    - Hospital Clinic De Barcelona
  - Barcelona, Spain, 08035
    - Hospital Vall d'Hebron
  - Barcelona, Spain, 08041
    - CAP Passeig de Maragall
  - Cartagena (Murcia), Spain, 30202
    - Hospital Santa Lucía
  - Cañaveral (Cáceres), Spain, 10820
    - Consultorio Cañaveral
  - Cáceres, Spain, 10820
    - Hospital La Princesa
  - Córdoba, Spain, 14004
    - Hospital Universitario Reina Sofia
  - El Palmar - Murcia, Spain, 30120
    - Hospital Universitario Virgen de La Arrixaca
  - Granada, Spain, 18012
    - Hospital Universitario San Cecilio
  - Jerez De La Frontera - Cádiz, Spain, 11407
    - Hospital Jerez de la Frontera
  - Las Palmas de Gran Canaria, Spain, 35010
    - Hospital de Gran Canaria Dr. Negrín
  - Leganes - Madrid, Spain, 28911
    - Hospital Severo Ochoa
  - Leon, Spain, 24071
    - Hospital de Leon
  - León, Spain, 24071
    - Hospital de Leon
  - Lugo, Spain, 27004
    - Hospital Universitario Lucus Augusti
  - Madrid, Spain, 28040
    - Fundacion Jimenez Diaz
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28046
    - Hospital La Paz
  - Madrid, Spain, 28031
    - Hospital Ramon y Cajal
  - Madrid, Spain, 28033
    - Centro de Salud Jazmin
  - Madrid, Spain, 28035
    - Centro de Salud Isla de Oza
  - Madrid, Spain, 28040
    - Hospital Regional Universitario de Málaga
  - Malaga, Spain, 29010
    - Hospital Virgen de la Victoria
  - Marbella . Málaga, Spain, 29603
    - Hospital Costa Del Sol
  - Palma de Mallorca, Spain, 07198
    - Hospital de Son Llàtzer
  - Pamplona, Spain, 31009
    - Complejo Hospitalario de Navarra
  - San Juan de Alicante, Spain, 03550
    - Hospital General Universitario de Alicante
  - Sant Joan Despi, Spain, 08970
    - Hospital Moisès Broggi
  - Santander, Spain, 39008
    - Hospital Universitario Marques de Valdecilla
  - Santiago de Compostela, Spain, 15706
    - Hospital Clínico de Santiago
  - Sevilla, Spain, 41014
    - Hospital Nuestra Señora de Valme
  - Sevilla, Spain, 41005
    - Hospital San Juan de Dios
  - Sevilla, Spain, 41012
    - Hospital Virgen Del Rocio
  - Sevilla, Spain, 41013
    - ABP Salud Sevilla
  - Valencia, Spain, 46015
    - Hospital Arnau De Vilanova
  - Valencia, Spain, 46014
    - Hospital General Universitario de Valencia
  - Valencia, Spain, 46017
    - Hospital Dr. Peset
  - Valencia, Spain, 46006
    - CS Ingeniero Joaquin Benlloch
  - Valencia, Spain, 46009
    - Hospital Univ La Fe
  - Vigo, Spain, 36211
    - Hospital Povisa
  - Vigo, Spain, 36200
    - Hospital Meixoeiro
  - Vélez-Málaga, Spain, 29700
    - Hospital Comarcal Axarquía
Sweden
- - Falun, Sweden, 791 82
    - Falu Lasarett
  - Göteborg, Sweden, 416 85
    - Sahlgrenska Universitetssjukhuset, Östra
  - Malmö, Sweden, 205 02
    - Skånes Universitetssjukhus, Malmö
  - Stockholm, Sweden, 182 88
    - Danderyds Sjukhus
  - Stockholm, Sweden, 111 35
    - Stockholm Heart Center AB
  - Umeå, Sweden, 901 85
    - Norrlands universitetssjukhus
  - Västerås, Sweden, 721 89
    - Centrallasarettet, Vasteras
United Kingdom
- - Acomb, United Kingdom, YO24 3BU
    - Gale Farm Surgery
  - Ashford, United Kingdom, TN24 0LZ
    - William Harvey Hospital
  - Axbridge, United Kingdom, BS26 2BJ
    - Axbridge and Wedmore Medical Practice
  - Basildon, United Kingdom, SS16 5NL
    - Basildon University Hospital
  - Basingstoke, United Kingdom, RG24 9NA
    - North Hampshire Hospital
  - Bath, United Kingdom, BA1 3NG
    - Royal United Hospital
  - Bath, United Kingdom, BA2 1NH
    - Beehive Surgery
  - Birmingham, United Kingdom, B18 7QH
    - Birmingham City Hospital
  - Bournemouth, United Kingdom, BH7 7DW
    - Royal Bournemouth and Christchurch Hospital
  - Bradford on Avon, United Kingdom, BA15 1DQ
    - Bradford on Avon Health Centre
  - Bristol, United Kingdom, BS2 8HW
    - Bristol Royal Infirmary
  - Bristol, United Kingdom, BS10 5NB
    - Southmead Hospital
  - Bristol, United Kingdom, BS10 6SP
    - Bradgate Surgery
  - Bristol, United Kingdom, BS21 6DG
    - Clevedon Riverside Group
  - Burbage, Hinkley, United Kingdom, LE10 2SE
    - Burbage Surgery
  - Bury St Edmunds, United Kingdom, IP33 2QZ
    - West Suffolk Hospital
  - Carlisle, United Kingdom, CA2 7HY
    - Cumberland Infirmary
  - Chester, United Kingdom, CH2 1UL
    - Countess of Chester Hospital
  - Cottingham, United Kingdom, HU16 5JQ
    - Castle Hill Hopsital
  - Crawley, United Kingdom, RH10 7DX
    - Pound Hill Medical Group
  - Dorchester, United Kingdom, DT1 2JY
    - Dorset County Hospital
  - Dudley, United Kingdom, DY1 2HQ
    - Russells Hall Hospital
  - Dundee, United Kingdom, DD1 9SY
    - Ninewells Hospital & Medical School
  - Durham, United Kingdom, DH1 5TW
    - University Hospital of North Durham
  - Exeter, United Kingdom, EX2 5DW
    - Royal Devon and Exeter Hospital
  - Gloucester, United Kingdom, GL1 3NN
    - Gloucestershire Royal Hospital
  - Hereford, United Kingdom, HR1 2ER
    - The County Hospital
  - High Wycombe, United Kingdom, HP11 2TT
    - Wycombe General Hospital
  - Honiton, United Kingdom, EX14 2NY
    - Honiton Surgery Group - Seamark
  - Hull, United Kingdom, HU12 8JD
    - Hedon Group Practice
  - Keighley, United Kingdom, BD20 6TD
    - Airedale General Hospital
  - Kendal, United Kingdom, LA9 7RG
    - Westmorland General Hospital
  - Leamington Spa, United Kingdom, CV32 4RA
    - Sherbourne Medical Centre
  - Leeds, United Kingdom, LS1 3EX
    - Leeds General Infirmary
  - Liverpool, United Kingdom, L9 7AL
    - Aintree University Hospital
  - Liverpool, United Kingdom, L14 3PE
    - Research Unit, Liverpool Heart and Chest Hospital
  - London, United Kingdom, SE13 6LH
    - University Hospital Lewisham
  - London, United Kingdom, SW17 0RE
    - St George's Hospital
  - Londonderry, United Kingdom, BT47 6SB
    - Altnagelvin Area Hospital
  - Luton, United Kingdom, LU4 0DZ
    - Luton and Dunstable University Hospital
  - Midsomer Norton, United Kingdom, BA3 2UH
    - St Chad's Surgery
  - Northampton, United Kingdom, NN1 5BD
    - Northampton General Hospital
  - Norwich, United Kingdom, NR4 7UY
    - Norfolk and Norwich University Hospital
  - Nuneaton, United Kingdom, CV10 7DJ
    - George Eliot Hospital
  - Oldham, United Kingdom, OL1 2JH
    - Royal Oldham Hospital
  - Perth, United Kingdom, PH1 1NX
    - Perth Royal Infirmary
  - Peterborough, United Kingdom, PE3 9GZ
    - Peterborough City Hospital
  - Plymouth, United Kingdom, PL6 8DH
    - Derriford Hospital
  - Poole, United Kingdom, BH15 2JB
    - Poole Hospital
  - Portadown, County Atrim, United Kingdom, BT63 5QQ
    - Craigavon Area Hospital
  - Preston, United Kingdom, PR2 9HT
    - Royal Preston Hospital
  - Reading, United Kingdom, RG1 5AN
    - Royal Berkshire Hospital
  - Redditch, United Kingdom, B98 7UB
    - Alexandra Hospital
  - Saint Just, Penzance, United Kingdom, TR19 7HX
    - Cape Cornwall Surgery
  - Salisbury, United Kingdom, SP2 8BJ
    - Salisbury District Hospital
  - Shrewsbury, United Kingdom, SY3 8XQ
    - Royal Shrewsbury Hospital
  - Slough, United Kingdom, SL2 4HL
    - Wexham Park Hospital
  - St Leonards on Sea, United Kingdom, TN37 7RD
    - The Conquest Hospital
  - Stafford, United Kingdom, ST16 3SA
    - County Hospital
  - Stocksfield, United Kingdom, NE43 7LL
    - Branch End Surgery
  - Stoke-on-Trent, United Kingdom, ST4 6QG
    - Royal Stoke University Hospital
  - Sunderland, United Kingdom, SR4 7TP
    - Sunderland Royal Hospital
  - Sutton in Ashfield, United Kingdom, NG17 4JL
    - King's Mill Hospital
  - Swansea, United Kingdom, SA2 8QA
    - Singleton Hospital
  - Taunton, United Kingdom, TA1 5DA
    - Musgrove Park Hospital
  - Torquay, United Kingdom, TQ2 7AA
    - Torbay Hospital
  - Tyne-and-Wear, United Kingdom, NE34 0PL
    - South Tyneside District Hospital
  - Uxbridge, United Kingdom, UB8 3NN
    - Hillingdon Hospital
  - Wansford, Peterborough, United Kingdom, PE8 6PL
    - Wansford Surgery
  - Warminster, United Kingdom, BA12 9AA
    - The Avenue Surgery
  - Warwick, United Kingdom, CV34 5BJ
    - Warwick Hospital
  - Welwyn Garden City, United Kingdom, AL7 4HQ
    - Queen Elizabeth II Hospital
  - Westbury, United Kingdom, BA13 3FQ
    - Westbury Group Practice
  - Westcliffe-on-Sea, United Kingdom, SS0 0RY
    - Southend General Hospital
  - Whitby, United Kingdom, YO21 1SD
    - Whitby Group Practice
  - Wirral, United Kingdom, CH49 5PE
    - Arrowe Park Hospital
  - Wolverhampton, United Kingdom, WV10 0QP
    - New Cross Hospital
  - York, United Kingdom, YO31 8HE
    - The York Hospital
  - York, United Kingdom, YO1 7NP
    - Jorvik Medical Practice
  - York, United Kingdom, YO24 4HD
    - York Medical Group
  - York, United Kingdom, YO32 5UA
    - MyHealth, Strensall Health Care Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with non-valvular AF

Description

Inclusion criteria:

Age =>18 years at enrollment
Male or female patient (or legally acceptable representative) willing and able to provide written informed consent
Patient newly diagnosed (< 3 months prior to baseline visit) with non-valvular AF and at risk for stroke.

Other inclusion criteria apply.

Exclusion criteria:

Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
AF with a generally reversible cause;
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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rate of Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction, Life-threatening Bleeding Events and Vascular Death) Time Frame: 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.	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.
Incidence Rate of Vascular Composite Outcome (Stroke, Systemic Embolism, Myocardial Infarction and Vascular Death) Time Frame: 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.	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.
Incidence Rate of Stroke or Systemic Embolism Time Frame: 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.	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.
Incidence Rate of Stroke Time Frame: 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.	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.
Incidence Rate of Transient Ischaemic Attack (TIA) Time Frame: 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.	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.
Incidence Rate of Systemic Embolism (SEE) Time Frame: 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.	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.
Incidence Rate of Pulmonary Embolism (PE) Time Frame: 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.	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.
Incidence Rate of Major Bleeding Events Time Frame: 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.	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.
Incidence Rate of Life-threatening Bleeding Events Time Frame: 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.	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.
Incidence Rate of Vascular Death Time Frame: 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.	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.
Incidence Rate of Myocardial Infarction Time Frame: 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.	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.
Incidence Rate of All-cause Death Time Frame: 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.	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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Related Info

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2012

Primary Completion (Actual)

December 13, 2019

Study Completion (Actual)

December 13, 2019

Study Registration Dates

First Submitted

August 20, 2012

First Submitted That Met QC Criteria

August 22, 2012

First Posted (Estimate)

August 23, 2012

Study Record Updates

Last Update Posted (Actual)

December 31, 2020

Last Update Submitted That Met QC Criteria

December 7, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

1160.136

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Stroke

NCT07208422

Recruiting

Task-Specific Self-Rehabilitation Training (TASSRET) Trial (TASSRET)

Stroke | Stroke Hemorrhagic | Stroke Ischemic | Hemiparesis After Stroke
NCT07224178

Recruiting

Left Atrial Strain and Cryptogenic Stroke (LAS-ESUS)

Hemorrhagic Stroke | Embolic Stroke of Undetermined Source | Ischemic Stroke, Cryptogenic | Recurrent Ischemic Stroke | Ischemic Stroke, Embolic
NCT07433972

Not yet recruiting

Changes in Hemodynamic Response Following Transcranial Electrical Stimulation in Sroke Individuals

Ischemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke Survivors
NCT07236216

Recruiting

Effects of tES Combined With CMDT Gait Training on Cognition, Cortical Activity, Spinal Motoneuron Excitability and Motor Performance in Stroke Individuals

Ischemic Stroke | Hemorrhagic Stroke | Subacute Stroke | Chronic Stroke Patient
NCT04956185

Recruiting

Data Collection of Patients Admitted to the Stroke Unit (PRODA-STROKE)

Stroke | Stroke, Ischemic | Stroke, Acute | Stroke Sequelae | Stroke Hemorrhagic
NCT05046106

Not yet recruiting

MLC1501 Study Assessing Efficacy in STROke Recovery (MAEStro)

Stroke | Stroke, Ischemic | Stroke Sequelae | Stroke, Cardiovascular | Strokes Thrombotic | Stroke, Embolic | Stroke, Cryptogenic
NCT07353203

Completed

Safety and Efficacy of Hip Assist Powered Exoskeleton for Gait Training in Patients With Late Subacute and Chronic Stroke (brain disorder)

Chronic Stroke | Subacute Stroke | Exoskeleton
NCT06127602

Recruiting

The REACTplusNMES Trial: A Double-blinded RCT (REACT+NMES)

Stroke, Ischemic | Stroke Hemorrhagic | Stroke, Cerebrovascular
NCT05815368

Recruiting

Efficacy of REMO Training for Hand Motor Recovery After Stroke (REMO)

Stroke | Stroke, Ischemic | Stroke Sequelae | Stroke Hemorrhagic
NCT07199322

Not yet recruiting

Clinical validatiOn of an AI-based DEcision Support System for Robotic Upper Limb Rehabilitation in Patients With Stroke. A CO-AIDER Study. (COAIDER)

Stroke | Stroke Hemorrhagic | Upper Limb Rehabilitation | Stroke Ischemic

GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)

GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)

Study Overview

Status

Conditions

Study Type

Enrollment (Actual)

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Sampling Method

Study Population

Description

Study Plan

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Stroke

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations