Clinical trial NCT02433366: Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation
Official title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-05-05
Enrollment: 1213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians prescribing dabigatran for patients with atrial fibrillation

Brief summary: The key focus of this survey will be to collect data on physicians awareness of the content of the Pradaxa® Prescriber Guide and the extent to which risk awareness is communicated to patients. The data collected with atrial fibrillation patients will show if and how well this information is received and understood.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

* Pradaxa® prescribers (cardiologists and primary care physicians)
* Patients with atrial fibrillation treated with Pradaxa®

Exclusion criteria:

As defined in Summary of Product Characteristics for patients treated with Pradaxa®

Primary outcomes:
measure: Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)
timeFrame: Day 1
measure: Patient's Understanding of the Disease, Bleeding Signs, What to do in Case of Bleeding and How to Deal With Emergency Situations (Measuring Physician Compliance From Patient Perspective) (Questionnaire)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Dobritch
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 81
city: Gabrovo
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 84
city: Montana
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 79
city: Plovdiv
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 85
city: Shumen
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 80
city: Sliven
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 86
city: Sofia
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 87
city: Stara Zagora
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 88
city: Varna
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 82
city: Veliko Tarnovo
country: Bulgaria
facility: Boehringer Ingelheim Investigational Site 83
city: ?eská Lípa
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 92
city: ?eské Bud?jovice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 93
city: ?eský Krumlov
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 94
city: B?eclav
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 90
city: Benesov u Prahy
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 89
city: Brno
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 91
city: Chomutov
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 95
city: Domazlice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 96
city: Havlí?k?v Brod
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 98
city: Haví?ov
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 97
city: Ho?ovice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 99
city: Hradec Králové
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 100
city: Ivan?ice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 101
city: Krom??íz
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 102
city: Kyjov
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 103
city: Liberec
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 104
city: Louny
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 105
city: Most
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 106
city: Nový Bor
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 107
city: Odry
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 108
city: Olomouc
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 109
city: Pardubice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 110
city: Plze?
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 111
city: Praha
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 112
city: Sternberk
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 113
city: Tehovec
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 115
city: Teplice
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 116
city: Tábor
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 114
city: Valasské Mezi?í?í
country: Czech Republic
facility: Boehringer Ingelheim Investigational Site 117
city: Copenhagen
country: Denmark
facility: Boehringer Ingelheim Investigational Site 69
city: Ambleuteuse
country: France
facility: Boehringer Ingelheim Investigational Site 25
city: Ardres
country: France
facility: Boehringer Ingelheim Investigational Site 68
city: Arnac pompadour
country: France
facility: Boehringer Ingelheim Investigational Site 26
city: Audincourt
country: France
facility: Boehringer Ingelheim Investigational Site 27
city: Bart
country: France
facility: Boehringer Ingelheim Investigational Site 28
city: Besançon
country: France
facility: Boehringer Ingelheim Investigational Site 29
city: Buissière galant
country: France
facility: Boehringer Ingelheim Investigational Site 30
city: Chalus
country: France
facility: Boehringer Ingelheim Investigational Site 32
city: Charbrignac
country: France
facility: Boehringer Ingelheim Investigational Site 31
city: Coussac Bonneval
country: France
facility: Boehringer Ingelheim Investigational Site 33
city: Decines
country: France
facility: Boehringer Ingelheim Investigational Site 34
city: Eckwersheim
country: France
facility: Boehringer Ingelheim Investigational Site 35
city: Geneuille
country: France
facility: Boehringer Ingelheim Investigational Site 36
city: Glandon
country: France
facility: Boehringer Ingelheim Investigational Site 37
city: Gruson
country: France
facility: Boehringer Ingelheim Investigational Site 65
city: Halluin
country: France
facility: Boehringer Ingelheim Investigational Site 38
city: Lanouaille
country: France
facility: Boehringer Ingelheim Investigational Site 39
city: Le catelet
country: France
facility: Boehringer Ingelheim Investigational Site 67
city: Le Haillan
country: France
facility: Boehringer Ingelheim Investigational Site 40
city: Lille
country: France
facility: Boehringer Ingelheim Investigational Site 41
city: Limoges
country: France
facility: Boehringer Ingelheim Investigational Site 42
city: Lomme
country: France
facility: Boehringer Ingelheim Investigational Site 43
city: Lyon
country: France
facility: Boehringer Ingelheim Investigational Site 44
city: Marseille
country: France
facility: Boehringer Ingelheim Investigational Site 45
city: Merignac
country: France
facility: Boehringer Ingelheim Investigational Site 46
city: Nexon
country: France
facility: Boehringer Ingelheim Investigational Site 47
city: Noaillan
country: France
facility: Boehringer Ingelheim Investigational Site 48
city: Paris
country: France
facility: Boehringer Ingelheim Investigational Site 24
city: Pompadour
country: France
facility: Boehringer Ingelheim Investigational Site 49
city: Saint Martial d'Albarede
country: France
facility: Boehringer Ingelheim Investigational Site 50
city: Saint Martin Sepert
country: France
facility: Boehringer Ingelheim Investigational Site 51
city: Saint Saud Lacousserie
country: France
facility: Boehringer Ingelheim Investigational Site 52
city: Saint Sornin Lavolps
country: France
facility: Boehringer Ingelheim Investigational Site 53
city: Saint Yrieix la Perche
country: France
facility: Boehringer Ingelheim Investigational Site 54
city: Saint-Hilaire-les-Places
country: France
facility: Boehringer Ingelheim Investigational Site 55
city: Schiltigheim
country: France
facility: Boehringer Ingelheim Investigational Site 56
city: Sochaux
country: France
facility: Boehringer Ingelheim Investigational Site 57
city: Strasbourg
country: France
facility: Boehringer Ingelheim Investigational Site 58
city: Talence
country: France
facility: Boehringer Ingelheim Investigational Site 59
city: Thiviers
country: France
facility: Boehringer Ingelheim Investigational Site 60
city: Tourcoing
country: France
facility: Boehringer Ingelheim Investigational Site 66
city: Tourmignies
country: France
facility: Boehringer Ingelheim Investigational Site 61
city: Villenave d'Ornon
country: France
facility: Boehringer Ingelheim Investigational Site 62
city: Voujeaucourt
country: France
facility: Boehringer Ingelheim Investigational Site 63
city: Weyersheim
country: France
facility: Boehringer Ingelheim Investigational Site 64
city: Berlin
country: Germany
facility: Boehringer Ingelheim Investigational Site 9
city: Bremen
country: Germany
facility: Boehringer Ingelheim Investigational Site 3
city: Chemnitz
country: Germany
facility: Boehringer Ingelheim Investigational Site 10
city: Düsseldorf
country: Germany
facility: Boehringer Ingelheim Investigational Site 5
city: Essen
country: Germany
facility: Boehringer Ingelheim Investigational Site 6
city: Frankfurt
country: Germany
facility: Boehringer Ingelheim Investigational Site 1
city: Hannover
country: Germany
facility: Boehringer Ingelheim Investigational Site 8
city: Heidelberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 14
city: Leipzig
country: Germany
facility: Boehringer Ingelheim Investigational Site 11
city: Mannheim
country: Germany
facility: Boehringer Ingelheim Investigational Site 2
city: Marburg
country: Germany
facility: Boehringer Ingelheim Investigational Site 7
city: München
country: Germany
facility: Boehringer Ingelheim Investigational Site 13
city: Nürnberg
country: Germany
facility: Boehringer Ingelheim Investigational Site 4
city: Rostock
country: Germany
facility: Boehringer Ingelheim Investigational Site 12
city: Banska Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 122
city: Bardejov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 127
city: Bratislava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 152
city: Cierna nad Tisou
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 146
city: Cierne Klacany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 149
city: Cierny Brod
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 154
city: Dolne Kockovce
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 139
city: Horny Vadicov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 141
city: Ivanka pri Dunaji
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 137
city: Jelka
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 140
city: Kokava nad Rimavicou
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 159
city: Kosice
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 125
city: Kostany nad Turcom
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 158
city: Krasno nad Kysucou
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 160
city: Lalinok
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 134
city: Lastovce
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 120
city: Liptovsky Hradok
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 155
city: Lucenec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 145
city: Nitra
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 144
city: Nove Mesto nad Vahom
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 119
city: Nove Zamky
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 150
city: Odorin
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 124
city: Oscadnica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 142
city: Poprad
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 157
city: Povazska Bystrica
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 128
city: Povazsky Chlmec
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 132
city: Presov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 118
city: Puchov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 138
city: Radola
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 143
city: Resov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 153
city: Revuca
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 156
city: Rozkovany
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 147
city: Rudinka
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 131
city: Sabinov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 126
city: Skalite
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 161
city: Spisska Nova Ves
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 123
city: Stranavy
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 130
city: Trebisov
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 121
city: Trnava
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 151
city: Trnove
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 129
city: Valasska Bela
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 135
city: Vrable
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 148
city: Zilina
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 133
city: Zvolen
country: Slovakia
facility: Boehringer Ingelheim Investigational Site 136
city: Baleares
country: Spain
facility: Boehringer Ingelheim Investigational Site 23
city: Barcelona
country: Spain
facility: Boehringer Ingelheim Investigational Site 22
city: Ciudad Real
country: Spain
facility: Boehringer Ingelheim Investigational Site 15
city: Galicia
country: Spain
facility: Boehringer Ingelheim Investigational Site 16
city: Madrid
country: Spain
facility: Boehringer Ingelheim Investigational Site 17
city: Murcia
country: Spain
facility: Boehringer Ingelheim Investigational Site 18
city: Sevilla
country: Spain
facility: Boehringer Ingelheim Investigational Site 19
city: Valencia
country: Spain
facility: Boehringer Ingelheim Investigational Site 20
city: Zaragoza
country: Spain
facility: Boehringer Ingelheim Investigational Site 21
city: Brighton
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 71
city: Cheadle
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 76
city: Essex
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 78
city: London
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 70
city: Manchester
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 77
city: Middlesex
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 74
city: Romford
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 73
city: Stockport
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 75
city: Surrey
country: United Kingdom
facility: Boehringer Ingelheim Investigational Site 72
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: