StrokeNCT01671007
GLORIA-AF Registry Program (Phase II/III - EU/EEA Member States)
An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 522 sites in 22 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Atrial Fibrillation
- How many people
- 10,471 participants
- Where
- 522 sitesin 22 countries
- Study dates
- 22 Aug 2012to 13 Dec 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with non-valvular AF
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
522 sites in 22 countries.
522 sites in 22 countries
France91 sites
HOP Général, Cardio, Abbeville
Abbeville, 80142
HOP d'Agen, Cardio, Agen
Agen, 47923
HOP d'Aix en Provence, cardio, Aix-en-Provence
Aix-en-Provence, 13616
HOP Général, Cardio, Abbeville
Aix-en-Provence, 13616
HOP Louis Pasteur, Cardio, Bagnols sur Ceze
Bagnols-sur-Cèze, 30205
HOP Bar le Duc, Pneumo, Bar le Duc
Bar-le-Duc, 55012
HOP de Bayonne
Bayonne, 64109
HOP Jean Minjoz
Besançon, 25030
CAB Berdagué P, Cardio, Beziers
Béziers, 34500
CAB Breton Dr Nicolas
Béziers, 34500
HOP de Béziers
Béziers, 34525
CLI Tivoli
Bordeaux, 33000
HOP Saint-André
Bordeaux, 33075
HOP Ambroise Paré
Boulogne-Billancourt, 92104
HOP Fleyriat, GERIA, Bourg-en-Bresse
Bour-en-Bresse, 01012
HOP de la Cavale Blanche
Brest, 29609
CLI les Cedres, Cardio, Brive La Gaillarde
Brive-la-Gaillarde, 19100
CAB Cadinot Dr D, Broglie
Broglie, 27270
CAB Frappé T, MG, BRUAY LA BUISSIERE
Bruay-la-Buissière, 62700
HOP Saint Martin, cardio, Caen
Caen, 14000
HOP Côte de Nacre
Caen, 14033
CAB Brunschwig, Cardio, Cannes
Cannes, 06400
HOP William Morey, Cardio, Chalon-Sur-Saône
Chalon-sur-Saône, 71100
CAB Loiselet P
Cherbourg, 50100
HOP Gabriel-Montpied
Clermont-Ferrand, 63000
CAB Brunehaut M, Cardio, Clermont Ferrand
Clermont-Ferrand, 63100
HOP Sud Francilien, Cardio, Corbeil-Essonnes
Corbeil-Essonnes, 91106
HOP Sud Francilien
Corbeil-Essonnes, 91106
HOP Henri Mondor
Créteil, 94000
HOP Bocage
Dijon, 21079
HOP Louis Pasteur, Cardio, Dole
Dole, 39108
CTRE Evecquemont, Cardio, Evecquemont
Évecquemont, 78740
HOP du Val d'Ariège, Cardio, Foix
Foix, 09107
HOP Michallon
La Tronche, 38700
CAB Benhalima B, Cardio, Le bourget
Le Bourget, 93350
HOP André Mignot
Le Chesnay, 78150
HOP Louis Pasteur, Cardio, Le Coudray
Le Coudray, 28630
HOP Le Mans
Le Mans, 72037
CAB Phan Cao Phai, Cardio, Levallois Perret
Levallois-Perret, 92300
CLI Libournais, Cardio, Libourne
Libourne, 33500
HOP Robert Boulin, cardio, Libourne
Libourne, 33500
CLI de la Louviere
Lille, 59000
CLI le Colombier, Cardio, Limoges
Limoges, 87100
HOP St Joseph-St Luc, Cardio, Lyon
Lyon, 69365
CAB Gartenlaub O, Cardio, Maison Alfort
Maisons-Alfort, 94700
CAB, Salem A, Cardio, Marseille
Marseille, 13001
HOP Européen
Marseille, 13003
CAB Scala P-J
Marseille, 13008
CAB Scemama J
Marseille, 13008
CAB vial, Cardio, Marseille
Marseille, 13009
HOP Timone
Marseille, 13385
HOP des Rayettes
Martigues, 13698
HOP de la région d'Annecy, Cardio, Metz-Tessy
Metz-Tessy, 74370
CAB Dillinger J, MG, Mondelange
Mondelange, 57300
CLI de Montargis, Cardio, Montargis
Montargis, 45200
CLI du Pont de Chaume
Montauban, 82000
HOP Raincy Montfermeil, Cardio, Montfermeil
Montfermeil, 93370
HOP Arnaud de Villeneuve
Montpellier, 34295
CAB Prunier L, Cardio, Montreuil
Montreuil, 93100
HOP Central, Neuro, Nancy
Nancy, 54035
HOP de Courbevoie, Spécialités Med, Neuilly sur Seine
Neuilly-sur-Seine, 92200
CAB Jamon Y, Cardio, Nîmes
Nîmes, 30000
HOP Carémeau
Nîmes, 3000
CLI Les Franciscaines, cardio, Nïmes
Nïmes, 30032
HOP Orléans, Cardio, Orléans
Orléans, 45100
CAB Audouin P, Cardio, Paris
Paris, 75007
CLI Turin, Cardio, Paris
Paris, 75008
CAB Cohen S, Paris
Paris, 75012
CAB Poulain F, Paris
Paris, 75014
HOP Européen G. Pompidou
Paris, 75015
HOP Pontchaillou
Rennes, 35033
CAB Duvilla N, Cardio, Rouen
Rouen, 76000
CAB Dascotte O, Cardio, St André lez Lille
Saint-André-lez-Lille, 59350
CAB Lequeux B, Cardio, Saint Benoit
Saint-Benoît, 86280
HOP Privé de la Loire, Cardio, Saint Etienne
Saint-Etienne, 42000
CAB Tessier P, Cardio, St Raphael
Saint-Raphaël, 83700
CAB Dary P, Cardio, St-Yrieix-la-Perche
Saint-Yrieix-la-Perche, 87500
CAB Muller J-J, Cardio, Strasbourg
Strasbourg, 67000
CLI de l'Ormeau, Cardio, Tarbes
Tarbes, 65000
CAB Houppe Nousse MP, Cardio, Thionville
Thionville, 57100
HOP du Léman
Thonon-les-Bains, 74203
HOP Sainte Musse
Toulon, 83100
HOP Rangueil
Toulouse, 31059
HOP Cardio, Tourcoing
Tourcoing, 59200
CAB Leprince P, MG, Tours
Tours, 37000
HOP Trousseau
Tours, 37044
CLI Village de Santé, Cardio, Trélaze
Trélazé, 49804
HOP Valence, Cardio, Valence
Valence, 26000
HOP Bretagne Atlantique, Cardio, Vannes
Vannes, 56017
CAB Lejay D, MG, Vieux Condé
Vieux-Condé, 59690
CAB Schaupp T, MG, Vihiers
Vihiers, 49310
United Kingdom81 sites
Gale Farm Surgery
Acomb, YO24 3BU
William Harvey Hospital
Ashford, TN24 0LZ
Axbridge and Wedmore Medical Practice
Axbridge, BS26 2BJ
Basildon University Hospital
Basildon, SS16 5NL
North Hampshire Hospital
Basingstoke, RG24 9NA
Royal United Hospital
Bath, BA1 3NG
Beehive Surgery
Bath, BA2 1NH
Birmingham City Hospital
Birmingham, B18 7QH
Royal Bournemouth and Christchurch Hospital
Bournemouth, BH7 7DW
Bradford on Avon Health Centre
Bradford on Avon, BA15 1DQ
Southmead Hospital
Bristol, BS10 5NB
Bradgate Surgery
Bristol, BS10 6SP
Bristol Royal Infirmary
Bristol, BS2 8HW
Clevedon Riverside Group
Bristol, BS21 6DG
Burbage Surgery
Burbage, Hinkley, LE10 2SE
West Suffolk Hospital
Bury St Edmunds, IP33 2QZ
Cumberland Infirmary
Carlisle, CA2 7HY
Countess of Chester Hospital
Chester, CH2 1UL
Castle Hill Hopsital
Cottingham, HU16 5JQ
Pound Hill Medical Group
Crawley, RH10 7DX
Dorset County Hospital
Dorchester, DT1 2JY
Russells Hall Hospital
Dudley, DY1 2HQ
Ninewells Hospital & Medical School
Dundee, DD1 9SY
University Hospital of North Durham
Durham, DH1 5TW
Royal Devon and Exeter Hospital
Exeter, EX2 5DW
Gloucestershire Royal Hospital
Gloucester, GL1 3NN
The County Hospital
Hereford, HR1 2ER
Wycombe General Hospital
High Wycombe, HP11 2TT
Honiton Surgery Group - Seamark
Honiton, EX14 2NY
Hedon Group Practice
Hull, HU12 8JD
Airedale General Hospital
Keighley, BD20 6TD
Westmorland General Hospital
Kendal, LA9 7RG
Leeds General Infirmary
Leeds, LS1 3EX
Research Unit, Liverpool Heart and Chest Hospital
Liverpool, L14 3PE
Aintree University Hospital
Liverpool, L9 7AL
University Hospital Lewisham
London, SE13 6LH
St George's Hospital
London, SW17 0RE
Altnagelvin Area Hospital
Londonderry, BT47 6SB
Luton and Dunstable University Hospital
Luton, LU4 0DZ
Arrowe Park Hospital
Metropolitan Borough of Wirral, CH49 5PE
St Chad's Surgery
Midsomer Norton, BA3 2UH
Northampton General Hospital
Northampton, NN1 5BD
Norfolk and Norwich University Hospital
Norwich, NR4 7UY
George Eliot Hospital
Nuneaton, CV10 7DJ
Royal Oldham Hospital
Oldham, OL1 2JH
Perth Royal Infirmary
Perth, PH1 1NX
Peterborough City Hospital
Peterborough, PE3 9GZ
Derriford Hospital
Plymouth, PL6 8DH
Poole Hospital
Poole, BH15 2JB
Craigavon Area Hospital
Portadown, County Atrim, BT63 5QQ
Royal Preston Hospital
Preston, PR2 9HT
Royal Berkshire Hospital
Reading, RG1 5AN
Alexandra Hospital
Redditch, B98 7UB
Sherbourne Medical Centre
Royal Leamington Spa, CV32 4RA
Cape Cornwall Surgery
Saint Just, Penzance, TR19 7HX
The Conquest Hospital
Saint Leonards-on-Sea, TN37 7RD
Salisbury District Hospital
Salisbury, SP2 8BJ
Royal Shrewsbury Hospital
Shrewsbury, SY3 8XQ
Wexham Park Hospital
Slough, SL2 4HL
County Hospital
Stafford, ST16 3SA
Branch End Surgery
Stocksfield, NE43 7LL
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG
Sunderland Royal Hospital
Sunderland, SR4 7TP
King's Mill Hospital
Sutton in Ashfield, NG17 4JL
Singleton Hospital
Swansea, SA2 8QA
Musgrove Park Hospital
Taunton, TA1 5DA
Torbay Hospital
Torquay, TQ2 7AA
South Tyneside District Hospital
Tyne-and-Wear, NE34 0PL
Hillingdon Hospital
Uxbridge, UB8 3NN
Wansford Surgery
Wansford, Peterborough, PE8 6PL
The Avenue Surgery
Warminster, BA12 9AA
Warwick Hospital
Warwick, CV34 5BJ
Queen Elizabeth II Hospital
Welwyn Garden City, AL7 4HQ
Westbury Group Practice
Westbury, BA13 3FQ
Southend General Hospital
Westcliffe-on-Sea, SS0 0RY
Whitby Group Practice
Whitby, YO21 1SD
New Cross Hospital
Wolverhampton, WV10 0QP
Jorvik Medical Practice
York, YO1 7NP
York Medical Group
York, YO24 4HD
The York Hospital
York, YO31 8HE
MyHealth, Strensall Health Care Centre
York, YO32 5UA
Germany80 sites
Bezirkskrankenhaus, Ansbach
Ansbach, 91522
Kerckhoff-Klinik, Bad Nauheim
Bad Nauheim, 61231
Neurologische Klinik GmbH, Bad Neustadt
Bad Neustadt/Saale, 97616
Sozialstiftung Bamberg
Bamberg, 96046
Evangelisches Elisabeth-Krankenhaus, Berlin Mitte
Berlin, 10785
Praxis Dr. Rieker, Berlin
Berlin, 10789
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 10967
Charité - Universitätsmedizin Berlin
Berlin, 12203
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 12351
Praxis Dr. Altmann, Berlin
Berlin, 12489
Praxisgemeinschaft Dres. Weinrich
Berlin, 12555
Praxis Dr. Claus, 10969 Berlin
Berlin, 12559
Kardiologische Praxis Dr. Jochen Bott
Berlin, 13405
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 13505
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 13509
Vivantes Netzwerk für Gesundheit GmbH
Berlin, 13585
Berufsgenossenschaftliches Universitätsklinikum Bergmannsheil gGmbH
Bochum, 44791
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, 28177
Klinikum Bremerhaven
Bremerhaven, 27574
Herz- und Gefaesszentrum am Neumarkt
Celle, 29221
Gemeinschaftspraxis Dr. med. J. Sek, Chemnitz
Chemnitz, 09116
Klinikum Coburg gGmbH
Coburg, 96450
Praxis für Kardiologie, Köln
Cologne, 51105
HELIOS Amper Kliniken, Dachau
Dachau, 85221
Kardiologische Praxisgemeinschaft,Darmstadt
Darmstadt, 64287
Praxis Dr. Rybak, Dessau
Dessau, 06847
Klinikum Lippe-Detmold GmbH
Detmold, 32756
Kardiologischen Gemeinschaftspraxis Dinslaken
Dinslaken, 46535
Praxis Dr. med. Bernhard-Paul Lodde
Dortmund, 44147
Praxisklinik Herz und Gefäße
Dresden, 01099
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, 01307
Evangelisches Krankenhaus Düsseldorf
Düsseldorf, 40217
Universitätsklinikum Erlangen
Erlangen, 91054
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45122
Klinikum Esslingen GmbH
Esslingen am Neckar, 73730
Praxis für Herz-Kreislauf-Erkrankungen Zeulenroda-Greiz
Greiz, 07973
Asklepios Klinik St. Geort
Hamburg, 20099
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Asklepios Klinik Harburg
Hamburg, 21075
Asklepios Klinik Barmbek
Hamburg, 22291
Praxis Herz im Zentrum Laske
Hanover, 30159
Universitätsklinikum Heidelberg
Heidelberg, 69120
Klinikum Ingolstadt GmbH
Ingolstadt, 85049
Praxis Dr. Mibach, Itzehoe
Itzehoe, 25524
Universitätsklinikum Jena
Jena, 07740
Kardiologische Gemeinschaftspraxis Kassel
Kassel, 34117
Praxis Dr. med. Frickel Siegfried
Kempen, 47906
Praxis Dr. med. Matthias Gabelmann
Kirchzarten, 79199
St. Antonius-Hospital, Kleve
Kleve, 47533
Universitätsklinikum Leipzig
Leipzig, 04103
Herzzentrum Leipzig GmbH
Leipzig, 04289
Klinikum Leverkusen gGmbH, Leverkusen
Leverkusen, 51375
Cardio Centrum Ludwigsburg
Ludwigsburg, 71634
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
Ludwigshafen, 67063
Universitätsklinikum Magdeburg A. ö. R.
Magdeburg, 39120
Gemeinsachftspraxis Regner/Schmitt/Kros, Mainz
Mainz, 55116
Praxis Dr.med. Jens Taggeselle, Markkleeberg
Markkleeberg, 04416
Klinikum Memmingen
Memmingen, 87700
Johannes Wesling Klinikum
Minden, 32429
Kliniken Maria Hilf GmbH
Mönchengladbach, 41063
Praxis Dr. med. Norbert Schön, Mühldorf
Mühldorf, 84453
Herzzentrum ALTER HOF München
München, 80331
Klinikum rechts der Isar der Technischen Universität München
München, 81675
Universitätsklinikum Münster
Münster, 45129
Praxis Dr. med. Joachim Gmehling
Nuremberg, 90402
Klinikum Osnabrück GmbH
Osnabrück, 49076
St. Vincenz-Krankenhaus GmbH
Paderborn, 33098
Kardiologische Praxis Papenburg
Papenburg, 26871
Kardiologisches Zentrum Peine
Peine, 31224
Städt. Krankenhaus, Pforzheim
Pforzheim, 75175
Kardiologische Gemeinschaftspraxis Potsdam
Potsdam, 14471
Kardiologische Gemeinschaftspraxis Rostock
Rostock, 18057
Kreisklinikum Siegen GmbH
Siegen, 57076
Berufsausübungsgemeinschaft Klein /Kratochvil
Stuttgart, 70178
Herzklinik Ulm Gemeinschaftspraxis
Ulm, 89077
Schwarzwald-Baar Klinikum
Villingen-Schwenningen, 78011
Kardiologische Praxis, Wermsdorf
Wermsdorf, 04779
MedKonsil, Wiesbaden
Wiesbaden, 65189
Kardiologische Gemeinschaftspraxis Wittenberg
Wittenberg, 06886
Universitätsklinikum Würzburg
Würzburg, 97080
Italy73 sites
Ospedale Riuniti Albano Genzano
Albano Laziale, 00041
Az. Osp. S.M. di Misericordia
Albenga, 17031
Az. Ospedaliere Umberto I di Ancona
Ancona, 60020
Ospedale Reg Umberto Parini
Aosta, 11100
Ospedale C. G. Mazzoni
Ascoli Piceno, 63100
AZ. Osp. Assisi U.O.
Assisi, 06081
Osp. SS Filippo Nicola
Avezzano, 67051
Policlinico di Bari
Bari, 70124
Policlinico Universitario di Bari
Bari, 70124
Policlinico S. Orsola Malpighi
Bologna, 40138
A. O. G. Brotzu
Cagliari, 09134
Presidio Ospedaliero di Castrovillari
Castrovillari (CS), 87012
P. O. "Garibaldi" - Nesima
Catania, 95122
A.O. Univ. Vittorio Ferrarotto S. Bambino
Catania, 95124
Policlinico Universitario Mater Domini, Universita di Catanzaro
Catanzaro, 88100
Osp. Clin. SS. Anunziata
Chieti, 66013
Azienda Ospedaliera Universitaria Arcispedale Sant'Anna
Cona (FE), 44124
Osp.S.Salvatore
Coppitto (AQ), 67100
AZ. Osped. Ospedale Maggiore di Crema
Crema (CR), 26013
A. Istituti Osp. di Cremona
Cremona, 26100
Ospedale S. Biagio
Domodossola (VB), 28845
P. O. S. Maria Nuova
Florence, 50122
Azienda Ospedaliera Careggi
Florence, 50134
Azienda Ospedaliera Careggi
Florence, 50139
Az.Osp. Universitaria "Ospedali Riuniti"
Foggia, 71100
Ospedale S. Cuore di Gesù
Gallipoli, 73014
Policlinico San Martino
Genova, 16132
Ospedale della Misericordia
Grosseto, 58100
Ospedale F. Veneziale
Isernia, 86170
Azienda Ospedaliera C. Poma
Mantua, 46100
Osp. Pediatrico Aprano Pasquinucci
Massa, 54100
Az Osp. Amico " Gaetano Fucito"
Mercato San Severino (SA), 84085
Centro Cardiologico Monzino-IRCCS
Milan, 20138
Nuovo Ospedale Civile S. Agostino-Estense
Modena, 46100
Osp.Riun.Valdichiana Senese
Montepulciano Senese (SI), 53045
A.O. San Gerardo di Monza
Monza (MB), 20900
Ospedale Nuovo Pellegrini
Naples, 80134
Ospedale Cardarelli
Naples, 80135
Osp.Sacro Cuore-Don Calabria
Negrar (VR), 37024
Az. Osp. San Giacomo
Novi Ligure, 15067
Az. Osp. San Francesco
Nuoro, 08100
Azienda Sanitaria Ospedale S. Luigi Gonzaga
Orbassano (TO), 10043
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
A.O. Univ. Policlinico Giaccone
Palermo, 90129
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Ospedale S.Maria della Misericordia, AO di Perugia
Perugia, 06156
Ospedale San Salvatore
Pesaro, 6121
Osp. Guglielmo da Saliceto AUSL di Piacenza
Piacenza, 29121
Ospedale Santa Corona Azienda Sanitaria Locale n.2 Savonese
Pietra Ligure, 17027
Ospedale di Cisanello
Pisa, 56124
Ospedale S.Tommaso dei Battuti
Portogruaro (VE), 30026
P.O.S. Maria Grazie
Pozzuoli, 80078
Azienda Unità Sanitaria Locale di Reggio Emilia
Reggio Emilia, 12100
Ospedale "Giambattista Grassi
Roma, 00122
Pol. Universitario Tor Vergata
Roma, 00133
Azienda Complessa Ospedaliera Ospedale San Fiippo Neri
Roma, 00135
Ospedale "S. Eugenio"
Roma, 00144
A.O. San Camillo Forlanini
Roma, 00151
Umberto I Pol. di Roma-Università di Roma La Sapienza
Roma, 00161
Policlinico Gemelli
Roma, 00168
Policlinico Casilino U.O. Cardiologia
Roma, 00169
Az. Osp.Madre Giuseppina Vannini-
Roma, 00177
Az. Osp. S.Giovanni-Addolorata
Roma, 00184
Ospedale S. Spirito
Roma, 00193
Nuovo Ospedale Civile di Sassuolo
Sassuolo, 41049
IRCCS Gruppo Multimedica
Sesto S.Giovanni (MI), 20090
A.O.U. Senese Policlinico Santa Maria alle Scotte
Siena, 53100
AO Città della Salute e della
Torino, 10126
Ospedale Mauriziano di Torino
Torino, 10128
Ospedale S. Maria di Ca' Foncello Azienda ULSS9 TREVISO
Treviso, 31100
A. O. S. Maria della Misericordia
Udine, 33100
A. O. Ospedale Circolo Fond. Macchi
Varese, 21100
Ospedale San Bortolo
Vicenza, 36100
Spain43 sites
Hospital A Coruña
A Coruña, 15006
Hospital del Mar
Barcelona, 08003
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
CAP Passeig de Maragall
Barcelona, 08041
Hospital La Princesa
Cáceres, 10820
Consultorio Cañaveral
Cañaveral (Cáceres), 10820
Hospital Santa Lucía
Cartagena (Murcia), 30202
Hospital Universitario Reina Sofía
Córdoba, 14004
Hospital Universitario Virgen de la Arrixaca
El Palmar - Murcia, 30120
Hospital Universitario San Cecilio
Granada, 18012
Hospital Jerez de la Frontera
Jerez de La Frontera - Cádiz, 11407
Hospital de Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria, 35010
Hospital Severo Ochoa
Leganes - Madrid, 28911
Hospital de León
León, 24071
Hospital Universitario Lucus Augusti
Lugo, 27004
Hospital Ramón y Cajal
Madrid, 28031
Centro de Salud Jazmin
Madrid, 28033
Centro de Salud Isla de Oza
Madrid, 28035
Fundación Jiménez Díaz
Madrid, 28040
Hospital Regional Universitario de Málaga
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital Virgen de la Victoria
Málaga, 29010
Hospital Costa del Sol
Marbella . Málaga, 29603
Hospital de Son Llàtzer
Palma de Mallorca, 07198
Complejo Hospitalario de Navarra
Pamplona, 31009
Hospital General Universitario de Alicante
Sant Joan d'Alacant, 03550
Hospital Moises Broggi
Sant Joan Despí, 08970
Hospital Universitario Marqués de Valdecilla
Santander, 39008
Hospital Clínico de Santiago
Santiago de Compostela, 15706
Hospital San Juan de Dios
Seville, 41005
Hospital Virgen del Rocío
Seville, 41012
ABP Salud Sevilla
Seville, 41013
Hospital Nuestra Señora de Valme
Seville, 41014
CS Ingeniero Joaquin Benlloch
Valencia, 46006
Hospital Univ La Fe
Valencia, 46009
Hospital General Universitario de Valencia
Valencia, 46014
Hospital Arnau de Vilanova
Valencia, 46015
Hospital Dr. Peset
Valencia, 46017
Hospital Comarcal Axarquía
Vélez-Málaga, 29700
Hospital Meixoeiro
Vigo, 36200
Hospital Povisa
Vigo, 36211
Netherlands21 sites
Jeroen Bosch Ziekenhuis-Hertogenbosch
's-Hertogenbosch, 5223 GZ
Amsterdam UMC, Locatie AMC
Amsterdam, 1105 AZ
Rijnstate Hospital
Arnhem, 6815 AD
IJsselland Ziekenhuis
Capelle aan den IJssel, 2906 ZC
Reinier de Graaf Groep
Delft, 2625 AD
Noordwest Ziekenhuisgroep
Den Helder, 1782 GZ
Deventer Ziekenhuis
Deventer, 7416 SE
Van Weel-Bethesda Ziekenhuis
Dirksland, 3247 BW
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Medisch Spectrum Twente
Enschede, 7512KZ
Zuyderland Medisch Centrum
Heerlen, 6419 PC
TREANT zorggroep
Hoogeveen, 7909 AA
Westfries Gasthuis
Hoorn, 1624 NP
METC Academisch Ziekenhuis Maastricht/Universiteit van Maastricht
Maastricht, 6229 HX
St. Antonius ziekenhuis, locatie Nieuwegein
Nieuwegein, 3435 CM
Havenziekenhuis
Rotterdam, 3011 TD
Zuyderland Medisch Centrum
Sittard - Geleen, 6162 BG
Antonius Ziekenhuis
Sneek, 8601 ZK
Ziekenhuis Rivierenland
Tiel, 4002 WP
VieCuri Medisch Centrum, locatie Venray
Venray, 5801 CE
Isala Zwolle
Zwolle, 8011 JW
Greece18 sites
University Hospital of Alexandroupolis
Alexandroupoli, 68100
Euroclinic of Athens
Athens, 11521
"Korgialeneio-Benakeio" Hellenic Red Cross Hospital
Athens, 11526
Sotiria Hosp.,Hypertension Unit,3rd Clinic of Internal Med.
Athens, 11527
Asclepion Voulas Hospital, Cardiological Clinic
Athens, 16673
General Hospital of Chalkida
Chalcis, 34100
General Hospital of Chania
Chania, 73100
General Hospital of Edessa, Cardiology Clinic
Edessa, 58200
Gen. Hosp. of Elefsina "Thriassio"
Elefsina, 19600
University General Hospital of Heraklion
Herakleion, Crete, 71110
Univ. Gen. Hosp. of Ioannina
Ioannina, 45500
General Hospital Komotinis
Komotini, 69100
General University Hospital of Larissa
Larissa, 41110
University of Patras Medical School
Pátrai, 26504
General Hospital of Rhodes
Rhodes, 85100
Gen. Hosp. of Thessaloniki "Hippokation", Cardiology Clinic
Thessaloniki, 54642
"Papageorgiou" General Hospital of Thessaloniki, B' Cardiolo
Thessaloniki, 56429
General Panarkadiko Hospital of Tripolis, Cardiology Clinic
Tripoli, 22100
Bulgaria14 sites
MHAT "Deva Maria", Dept. of Cardiology, Burgas
Burgas, 5800
MHAT "Dr.Stambolski", Cardiology&Intensiv Care Dept,Kazanlak
Kazanlak, 6100
UMHAT Sv.Georgi EAD
Plovdiv, 4002
MHAT, Fourth Dept. of Internal Medicine, Rousse
Rousse, 7002
MHAT Akta Medika OOD, Sevlievo
Sevlievo, 5400
Multiprofile Hospital for Active Treatment, Sliven
Sliven, 8800
Diagnostic & Consultancy Center "Ascendent", Sofia
Sofia, 1202
MHAT "National Cardiology Hosp." Cardiology Dept., Sofia
Sofia, 1309
University Multiprofile Hospital 'Alexandrovska', Sofia
Sofia, 1431
MHAT, "Vita" Surgery Department, Sofia
Sofia, 1505
MHAT "Tsaritsa Yoanna-ISUL" Clinic of Cardiology, Sofia
Sofia, 1527
UMHAT, Clinic of Cardiology, Stara Zagora
Stara Zagora, 6003
Medical Military Academy MHAT Varna
Varna, 9010
Specialized Hosp.f.Active Treatment, Cardiology Dept, Yambol
Yambol, 8600
Poland14 sites
Univ. Clinic Hosp, Bialystok
Bialystok, 15276
Private Practice Jacek Kowalczyk, Bytom
Bytom, 41902
Specialist Out-patient Clinics 'Na Gornej',Cieszyn
Cieszyn, 43400
Specialistic Cardiology&Hypertension Out-patient Clin,Kielce
Kielce, 25525
Private Practice of Heart Diseases Malgorzata Lelonek,Lodz
Lodz, 90727
Allmedica Sp. z.o.o, prac. Nowy Targ
Nowy Targ, 34400
Private Specialistic Practices, Nysa
Nysa, 48300
Reg.Hosp, Intern.Med.Ward w/ Intensive Cardiol.Care, Opoczno
Opoczno, 26300
Szpital Specjalistyczny w Pulawach
Puławy, 24-100
Cardiology Out-patient Clinic "Cardio-Plus", Radlin
Radlin, 44144
Internal Medicine,Cardiol.practiceWanda&Jerzy Sudnik,Sokolka
Sokółka, 16100
Individual Specialist.Private Practice Dr.W.Krysiak,Szczecin
Szczecin
Individual Specialistic Private Practice,Dr.A.Tomasik,Zabrze
Zabrze, 41800
Slaskie Center Heart Disease SUM,Cardiol.&Electr.Clin.Zabrze
Zabrze, 41800
Romania12 sites
CMI Dr. Bogdan Minescu, Braila
Brăila, 810262
Emergency University Hospital, Bucharest
Bucharest, 050098
ILRO Medical SRL, Bucharest
Bucharest, 10628
Med.Centre Diagnosis,Treatm&Prev Med.Cardiol.Dept, Bucharest
Bucharest, 11792
SC Titan Medical SRL, Bucharest
Bucharest, 21323
Humanitas Medical Center, Bucharest
Bucharest, 62272
SC Cardiomed SRL, Cluj Napoca
Cluj-Napoca, 400015
SC Cardiomed SRL, Constanta
Constanța, 900704
S.C Cardiomed S.R.L
Craiova, 200147
SC Cardiomed SRL, Iasi
Iași, 700034
Galenus Medical Center, Targu Mures
Târgu Mureş, 540099
Medicorclinics, Timisoara
Timișoara, 300014
Portugal11 sites
Hospital Garcia de Orta, EPE
Almada, 2805-267
CHLO, EPE - Hospital de Santa Cruz
Carnaxide, 2799-523
Centro Hospitalar da Cova da Beira Hospital Pêro da Covilhã
Covilha, 6200-251
Hospital do Espírito Santo, EPE
Evora, 7000-811
Centro Hospitalar Algarve, EPE
Faro, 8000-386
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1064-035
CHLO, EPE - Hospital S. Francisco Xavier
Lisbon, 1449-005
Hospital da Luz
Lisbon, 1500-650
CHULN, EPE - Hospital de Santa Maria
Lisbon, 1649-035
Centro Hospitalar Universitário São João,EPE
Porto, 4202-451
Hospital de Santiago
Setúbal, 2900-722
Croatia10 sites
Magdalena-Special Hosp.f.Cardiovas.Surgery,Krapinske Toplice
Krapinske Toplice, 49217
Thalassoterapia,Rehab.of heart&lung,Cardiology Clin, Opatija
Opatija, 51410
Clinical Hospital Split
Split, 21000
General Hosp. Zadar, Clinic of Internal Med, Cardiology Dept
Zadar, 23 000
Clinical Hosp.Merkur,Clin.Internal Med,Cardiology Dep,Zagreb
Zagreb, 10 000
Polyclinic St. Luke, Cardiology Dept., Zagreb
Zagreb, 10 000
Univ. Hosp. Sisters of Mercy, Cardiology Dept., Zagreb
Zagreb, 10 000
University hospital center Zagreb
Zagreb, 10 000
Univ. Hosp. Sisters of Mercy, Neurology Clinic, Zagreb
Zagreb, 100 00
University hospital center Zagreb
Zagreb, 10000
Belgium9 sites
Namur - HOSP St-Luc de Bouge
Bouge/Namur, 5004
AZ Sint-Lucas
Bruges, 8310
Brussels - HOSP St-Jan
Brussels, 1000
ULB Hopital Erasme
Brussels, 1070
Brussels - HOSP Europe (Ste-Elisabeth)
Brussels, 1180
Ziekenhuis Oost-Limburg - Campus Sint-Jan
Genk, 3600
Liège - HOSP CHR de la Citadelle
Liège, 4000
Ottignies - HOSP St-Pierre
Ottignies, 1340
Tienen - PRAC De Wolf, Luc
Tienen, 3300
Norway8 sites
Legegruppen Arendal
Arendal, N-4836
Vestre Viken HF, Bærum sykehus
Drammen, N-3004
Medisinsk Senter Fornebu DA
Fornebu, N-1364
Vestre Viken, Ringerike Sykehus HF
Hønefoss, N-3511
Sykehuset Innlandet HF, Kongsvinger
Kongsvinger, N-2212
Sykehuset Innlandet HF, Avd. Lillehammer
Lillehammer, N-2629
Volvat Medisinske senter, Oslo
Oslo, N-0370
Universitetssykehuset Nord-Norge, Tromsø
Tromsø, N-9038
Sweden7 sites
Falu lasarett
Falun, 791 82
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, 416 85
Skånes universitetssjukhus, Malmö
Malmö, 205 02
Stockholm Heart Center AB
Stockholm, 111 35
Danderyds Sjukhus
Stockholm, 182 88
Norrlands Universitetssjukhus
Umeå, 901 85
Centrallasarettet, Västerås
Västerås, 721 89
Austria6 sites
Klinik Pirawarth, Therapie und Rehabilitation, Bad Pirawarth
Bad Pirawarth, 2222
KH der Barmherzigen Schwestern Linz
Linz, 4010
Kepler Univ. Klinikum Linz
Linz, 4021
Ordination Dr. Martin Koschutnik, Oberwart
Oberwart, 7400
KH d. Barmherzigen Brüder Wien, Neurologie
Vienna, 1020
AKH - Medical University of Vienna
Vienna, 1090
Czechia6 sites
Cardiology Private Practice, Brno
Brno, 61600
University Hospital Brno
Brno, 625 00
Cardiocentrum, Private Practice, Kladno
Kladno, 272 80
Cardiology Private Practice
Litovel, 784 01
Cardiology Private Practice, Praha
Prague, 15005
Cardiology Private Practice, Roznov pod Radhostem
Rožnov pod Radhoštěm, 756 61
Denmark6 sites
Forskningens Hus
Aalborg, 9000
Sydvestjysk Sygehus Esbjerg, Hjertemedicinsk afd.
Esbjerg, 6700
Herlev and Gentofte Hospital
Herlev, 2730
Nordsjællands Hospital - Hillerød
Hillerød, 3400
Kolding Sygehus
Kolding, 6000
Odense University Hospital
Odense, 5000
Ireland5 sites
Portiuncula Hospital
Ballinasloe, H53 T971
Adelaide & Meath Hospital
Dublin, 24
St James's Hospital
Dublin, Dublin 8
University Hospital Galway
Galway, GALWAY
The Redhouse Family Practice
Mallow
Latvia3 sites
Liepaja Regional Hospital, Therapy Department
Liepāja, 3414
P.Stradins Clin.Univ.Hosp,Cardio.Diagnos&Outpatient Dep,Riga
Riga, 1002
Riga East University Hospital
Riga, 1038
Estonia2 sites
East Tallinn Central Hospital
Tallinn, 10138
North Estonia Med.Centre,Internal Med.Clin/Cardiology,Tallin
Tallinn, 134 19
Slovenia2 sites
General Hospital Celje
Celje, 3000
Univ. Medical Centre Ljubljana, Dept. of Vascular Diseases
Ljubljana, 1000
About this study
Official title: 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.
- Conditions
- Stroke, Atrial Fibrillation
- Medical subject headings
- Stroke, Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
Incidence rate of stroke or systemic embolism on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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
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.
Measured: 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)
Incidence rate of transient ischaemic attack (TIA) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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)
Incidence rate of systemic embolism (SEE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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)
Incidence rate of pulmonary embolism (PE) on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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
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.
Measured: 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
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.
Measured: 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
Incidence rate of vascular death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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
Incidence rate of myocardial infarction on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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
Incidence rate of all-cause death on restricted set that included Dabigatran etexilate (DE) and Vitamin K Antagonist (VKA) only.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study start22 Aug 2012
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671007
- Sponsor's protocol ID
- 1160.136
- Status last verified
- Dec 2020
- First submitted
- 20 Aug 2012
- Last updated
- 31 Dec 2020
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.
PubMed 39511367Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.
PubMed 37753446Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.
PubMed 37566295Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.
PubMed 35876418Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.
PubMed 35488127Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16.
PubMed 35294625Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.
PubMed 35294623Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.
PubMed 35243870Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.
PubMed 33338644Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.
PubMed 29653649Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.
PubMed 24576516
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLORIA - AF: Global Registry on Long-Term Oral Anti-thrombotic TReatment In PAtients With Atrial Fibrillation (Phase II/III - EU/EEA Member States)
- ClinicalTrials.gov ID
- NCT01671007
- Acronym / sponsor ID
- 1160.136
- Conditions
- Stroke, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10,471 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2012 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Posted 31 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with non-valvular AF
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39511367Joddrell M, El-Bouri W, Harrison SL, Huisman MV, Lip GYH, Zheng Y; GLORIA-AFinvestigators. Machine learning for outcome prediction in patients with non-valvular atrial fibrillation from the GLORIA-AF registry. Sci Rep. 2024 Nov 7;14(1):27088. doi: 10.1038/s41598-024-78120-z.
- Derived from this study: PubMed 37753446Romiti GF, Corica B, Proietti M, Mei DA, Frydenlund J, Bisson A, Boriani G, Olshansky B, Chan YH, Huisman MV, Chao TF, Lip GYH; GLORIA-AF Investigators. Patterns of oral anticoagulant use and outcomes in Asian patients with atrial fibrillation: a post-hoc analysis from the GLORIA-AF Registry. EClinicalMedicine. 2023 Aug 25;63:102039. doi: 10.1016/j.eclinm.2023.102039. eCollection 2023 Sep.
- Derived from this study: PubMed 37566295Ding WY, Fawzy AM, Romiti GF, Proietti M, Pastori D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Validating the predictive ability of the 2MACE score for major adverse cardiovascular events in patients with atrial fibrillation: results from phase II/III of the GLORIA-AF registry. J Thromb Thrombolysis. 2024 Jan;57(1):39-49. doi: 10.1007/s11239-023-02866-y. Epub 2023 Aug 11.
- Derived from this study: PubMed 35876418Ding WY, Lane DA, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Incidence and Risk Factors for Residual Adverse Events Despite Anticoagulation in Atrial Fibrillation: Results From Phase II/III of the GLORIA-AF Registry. J Am Heart Assoc. 2022 Aug 2;11(15):e026410. doi: 10.1161/JAHA.122.026410. Epub 2022 Jul 25.
- Derived from this study: PubMed 35488127Ding WY, Calvert P, Gupta D, Huisman MV, Lip GYH; GLORIA-AF Investigators. Impact of early ablation of atrial fibrillation on long-term outcomes: results from phase II/III of the GLORIA-AF registry. Clin Res Cardiol. 2022 Sep;111(9):1057-1068. doi: 10.1007/s00392-022-02022-1. Epub 2022 Apr 29.
- Derived from this study: PubMed 35294625Lip GYH, Kotalczyk A, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Marler S, Gurusamy VK, Huisman MV; GLORIA-AF Investigators. Comparative effectiveness and safety of non-vitamin K antagonists for atrial fibrillation in clinical practice: GLORIA-AF Registry. Clin Res Cardiol. 2022 May;111(5):560-573. doi: 10.1007/s00392-022-01996-2. Epub 2022 Mar 16.
- Derived from this study: PubMed 35294623Huisman MV, Teutsch C, Lu S, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Lohmann R, Gurusamy VK, Bartels DB, Lip GYH; GLORIA-AF Investigators. Dabigatran versus vitamin K antagonists for atrial fibrillation in clinical practice: final outcomes from Phase III of the GLORIA-AF registry. Clin Res Cardiol. 2022 May;111(5):548-559. doi: 10.1007/s00392-021-01957-1. Epub 2022 Mar 16.
- Derived from this study: PubMed 35243870Bayer V, Kotalczyk A, Kea B, Teutsch C, Larsen P, Button D, Huisman MV, Lip GYH, Olshansky B. Global Oral Anticoagulation Use Varies by Region in Patients With Recent Diagnosis of Atrial Fibrillation: The GLORIA-AF Phase III Registry. J Am Heart Assoc. 2022 Mar 15;11(6):e023907. doi: 10.1161/JAHA.121.023907. Epub 2022 Mar 4.
- Derived from this study: PubMed 33338644Ntaios G, Huisman MV, Diener HC, Halperin JL, Teutsch C, Marler S, Gurusamy VK, Thompson M, Lip GYH, Olshansky B; GLORIA-AF Investigators. Anticoagulant selection in relation to the SAMe-TT2R2 score in patients with atrial fibrillation: The GLORIA-AF registry. Hellenic J Cardiol. 2021 Mar-Apr;62(2):152-157. doi: 10.1016/j.hjc.2020.11.009. Epub 2020 Dec 15.
- Derived from this study: PubMed 29653649Huisman MV, Rothman KJ, Paquette M, Teutsch C, Diener HC, Dubner SJ, Halperin JL, Ma CS, Zint K, Elsaesser A, Lu S, Bartels DB, Lip GYH; GLORIA-AF Investigators. Two-year follow-up of patients treated with dabigatran for stroke prevention in atrial fibrillation: Global Registry on Long-Term Antithrombotic Treatment in Patients with Atrial Fibrillation (GLORIA-AF) registry. Am Heart J. 2018 Apr;198:55-63. doi: 10.1016/j.ahj.2017.08.018. Epub 2017 Aug 31.
- Derived from this study: PubMed 24576516Huisman MV, Lip GY, Diener HC, Dubner SJ, Halperin JL, Ma CS, Rothman KJ, Teutsch C, Zint K, Ackermann D, Clemens A, Bartels DB. Design and rationale of Global Registry on Long-Term Oral Antithrombotic Treatment in Patients with Atrial Fibrillation: a global registry program on long-term oral antithrombotic treatment in patients with atrial fibrillation. Am Heart J. 2014 Mar;167(3):329-34. doi: 10.1016/j.ahj.2013.12.006. Epub 2013 Dec 19.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
522 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Atrial Fibrillation, run by Boehringer Ingelheim at 522 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 522 sites in France, United Kingdom, Germany, Italy, Spain and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01671007, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2020.