Evaluation the Effectiveness of the Risk Minimisation Activities in the Treatment of Stroke Prevention in Atrial Fibrillation

NCT02433366 | Completed Results

• 1 other identifier: 1160.149
• Study Type: observational
• Target: 1,213
• Locations: 8 countries
• Sites: 161

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.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)

  The Outcome measure is summarized using the following categories; A: Physicians who spontaneously remembered the receipt of the Patient alert card, B: Physicians who spontaneously remembered the receipt of the Prescriber Guide, C: Physicians who were satisfied with the information provided in the Prescriber guide, D: Physicians who were aware of the importance of determining and controlling of the Patients renal function for correct pradaxa dosing. This Outcome measure is applicable only for the Physicians group.

  Day 1

• 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)

  The Outcome measure is summarized using the following categories; A: Patients who received the Patient Alert Card, read it and understood its content, B: Patients who completed the Patient Alert Card with the patient specific information, C: Patients who were well informed about their treatment and the actions to be taken in case of serious complications, D: Patents who knew about the anticoagulant effect of Pradaxa®, E: Patients who were well aware of the potential side effect-bruising, F: Patients who were well aware of the potential side effect-bleeding. This Outcome measure is applicable only for the Patients group.

  Day 1

Study Arms (2)

Patients

Physicians

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Physicians prescribing dabigatran for patients with atrial fibrillation

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (161)

Boehringer Ingelheim Investigational Site 81

Dobrich, Bulgaria

Location

Boehringer Ingelheim Investigational Site 84

Gabrovo, Bulgaria

Location

Boehringer Ingelheim Investigational Site 79

Montana, Bulgaria

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Boehringer Ingelheim Investigational Site 85

Plovdiv, Bulgaria

Location

Boehringer Ingelheim Investigational Site 80

Shumen, Bulgaria

Location

Boehringer Ingelheim Investigational Site 86

Sliven, Bulgaria

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Boehringer Ingelheim Investigational Site 87

Sofia, Bulgaria

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Boehringer Ingelheim Investigational Site 88

Stara Zagora, Bulgaria

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Boehringer Ingelheim Investigational Site 82

Varna, Bulgaria

Location

Boehringer Ingelheim Investigational Site 83

Veliko Tarnovo, Bulgaria

Location

Boehringer Ingelheim Investigational Site 92

?eská Lípa, Czechia

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Boehringer Ingelheim Investigational Site 93

?eské Bud?jovice, Czechia

Location

Boehringer Ingelheim Investigational Site 94

?eský Krumlov, Czechia

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Boehringer Ingelheim Investigational Site 90

B?eclav, Czechia

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Boehringer Ingelheim Investigational Site 89

Benesov U Prahy, Czechia

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Boehringer Ingelheim Investigational Site 91

Brno, Czechia

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Boehringer Ingelheim Investigational Site 95

Chomutov, Czechia

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Boehringer Ingelheim Investigational Site 96

Domažlice, Czechia

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Boehringer Ingelheim Investigational Site 97

Haví?ov, Czechia

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Boehringer Ingelheim Investigational Site 98

Havlí?k?v Brod, Czechia

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Boehringer Ingelheim Investigational Site 99

Ho?ovice, Czechia

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Boehringer Ingelheim Investigational Site 100

Hradec Králové, Czechia

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Boehringer Ingelheim Investigational Site 101

Ivan?ice, Czechia

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Boehringer Ingelheim Investigational Site 102

Krom??íz, Czechia

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Boehringer Ingelheim Investigational Site 103

Kyjov, Czechia

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Boehringer Ingelheim Investigational Site 104

Liberec, Czechia

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Boehringer Ingelheim Investigational Site 105

Louny, Czechia

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Boehringer Ingelheim Investigational Site 106

Most, Czechia

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Boehringer Ingelheim Investigational Site 107

Nový Bor, Czechia

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Boehringer Ingelheim Investigational Site 108

Odry, Czechia

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Boehringer Ingelheim Investigational Site 109

Olomouc, Czechia

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Boehringer Ingelheim Investigational Site 110

Pardubice, Czechia

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Boehringer Ingelheim Investigational Site 111

Plze?, Czechia

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Boehringer Ingelheim Investigational Site 112

Prague, Czechia

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Boehringer Ingelheim Investigational Site 113

Sternberk, Czechia

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Boehringer Ingelheim Investigational Site 114

Tábor, Czechia

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Boehringer Ingelheim Investigational Site 115

Tehovec, Czechia

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Boehringer Ingelheim Investigational Site 116

Teplice, Czechia

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Boehringer Ingelheim Investigational Site 117

Valasské Mezi?í?í, Czechia

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Boehringer Ingelheim Investigational Site 69

Copenhagen, Denmark

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Boehringer Ingelheim Investigational Site 25

Ambleuteuse, France

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Boehringer Ingelheim Investigational Site 68

Ardres, France

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Boehringer Ingelheim Investigational Site 26

Arnac-Pompadour, France

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Boehringer Ingelheim Investigational Site 27

Audincourt, France

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Boehringer Ingelheim Investigational Site 28

Bart, France

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Boehringer Ingelheim Investigational Site 29

Besançon, France

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Boehringer Ingelheim Investigational Site 30

Buissière Galant, France

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Boehringer Ingelheim Investigational Site 31

Charbrignac, France

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Boehringer Ingelheim Investigational Site 32

Châlus, France

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Boehringer Ingelheim Investigational Site 33

Coussac-Bonneval, France

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Boehringer Ingelheim Investigational Site 34

Décines-Charpieu, France

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Boehringer Ingelheim Investigational Site 35

Eckwersheim, France

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Boehringer Ingelheim Investigational Site 36

Geneuille, France

Location

Boehringer Ingelheim Investigational Site 37

Glandon, France

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Boehringer Ingelheim Investigational Site 65

Gruson, France

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Boehringer Ingelheim Investigational Site 38

Halluin, France

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Boehringer Ingelheim Investigational Site 39

Lanouaille, France

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Boehringer Ingelheim Investigational Site 67

Le Catelet, France

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Boehringer Ingelheim Investigational Site 40

Le Haillan, France

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Boehringer Ingelheim Investigational Site 41

Lille, France

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Boehringer Ingelheim Investigational Site 42

Limoges, France

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Boehringer Ingelheim Investigational Site 43

Lomme, France

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Boehringer Ingelheim Investigational Site 44

Lyon, France

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Boehringer Ingelheim Investigational Site 45

Marseille, France

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Boehringer Ingelheim Investigational Site 46

Mérignac, France

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Boehringer Ingelheim Investigational Site 47

Nexon, France

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Boehringer Ingelheim Investigational Site 48

Noaillan, France

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Boehringer Ingelheim Investigational Site 24

Paris, France

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Boehringer Ingelheim Investigational Site 52

Saint Saud Lacousserie, France

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Boehringer Ingelheim Investigational Site 55

Saint-Hilaire-les-Places, France

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Boehringer Ingelheim Investigational Site 50

Saint-Martial-d'Albarède, France

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Boehringer Ingelheim Investigational Site 51

Saint-Martin-Sepert, France

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Boehringer Ingelheim Investigational Site 53

Saint-Sornin-Lavolps, France

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Boehringer Ingelheim Investigational Site 54

Saint-Yrieix-la-Perche, France

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Boehringer Ingelheim Investigational Site 56

Schiltigheim, France

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Boehringer Ingelheim Investigational Site 57

Sochaux, France

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Boehringer Ingelheim Investigational Site 58

Strasbourg, France

Location

Boehringer Ingelheim Investigational Site 59

Talence, France

Location

Boehringer Ingelheim Investigational Site 60

Thiviers, France

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Boehringer Ingelheim Investigational Site 66

Tourcoing, France

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Boehringer Ingelheim Investigational Site 61

Tourmignies, France

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Boehringer Ingelheim Investigational Site 49

Val Pompadour, France

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Boehringer Ingelheim Investigational Site 62

Villenave-d'Ornon, France

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Boehringer Ingelheim Investigational Site 63

Voujeaucourt, France

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Boehringer Ingelheim Investigational Site 64

Weyersheim, France

Location

Boehringer Ingelheim Investigational Site 9

Berlin, Germany

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Boehringer Ingelheim Investigational Site 3

Bremen, Germany

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Boehringer Ingelheim Investigational Site 10

Chemnitz, Germany

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Boehringer Ingelheim Investigational Site 5

Düsseldorf, Germany

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Boehringer Ingelheim Investigational Site 6

Essen, Germany

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Boehringer Ingelheim Investigational Site 1

Frankfurt, Germany

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Boehringer Ingelheim Investigational Site 8

Hanover, Germany

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Boehringer Ingelheim Investigational Site 14

Heidelberg, Germany

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Boehringer Ingelheim Investigational Site 11

Leipzig, Germany

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Boehringer Ingelheim Investigational Site 2

Mannheim, Germany

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Boehringer Ingelheim Investigational Site 7

Marburg, Germany

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Boehringer Ingelheim Investigational Site 13

München, Germany

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Boehringer Ingelheim Investigational Site 4

Nuremberg, Germany

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Boehringer Ingelheim Investigational Site 12

Rostock, Germany

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Boehringer Ingelheim Investigational Site 122

Banská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 127

Bardejov, Slovakia

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Boehringer Ingelheim Investigational Site 152

Bratislava, Slovakia

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Boehringer Ingelheim Investigational Site 146

Čierna nad Tisou, Slovakia

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Boehringer Ingelheim Investigational Site 149

Čierne Kľačany, Slovakia

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Boehringer Ingelheim Investigational Site 154

Čierny Brod, Slovakia

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Boehringer Ingelheim Investigational Site 139

Dolné Kočkovce, Slovakia

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Boehringer Ingelheim Investigational Site 141

Horný Vadičov, Slovakia

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Boehringer Ingelheim Investigational Site 137

Ivanka pri Dunaji, Slovakia

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Boehringer Ingelheim Investigational Site 140

Jelka, Slovakia

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Boehringer Ingelheim Investigational Site 159

Kokava nad Rimavicou, Slovakia

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Boehringer Ingelheim Investigational Site 125

Košice, Slovakia

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Boehringer Ingelheim Investigational Site 158

Košťany nad Turcom, Slovakia

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Boehringer Ingelheim Investigational Site 160

Krásno nad Kysucou, Slovakia

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Boehringer Ingelheim Investigational Site 134

Lalinok, Slovakia

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Boehringer Ingelheim Investigational Site 120

Lastovce, Slovakia

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Boehringer Ingelheim Investigational Site 155

Liptovský Hrádok, Slovakia

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Boehringer Ingelheim Investigational Site 145

Lučenec, Slovakia

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Boehringer Ingelheim Investigational Site 144

Nitra, Slovakia

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Boehringer Ingelheim Investigational Site 119

Nové Mesto nad Váhom, Slovakia

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Boehringer Ingelheim Investigational Site 150

Nové Zámky, Slovakia

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Boehringer Ingelheim Investigational Site 124

Odorín, Slovakia

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Boehringer Ingelheim Investigational Site 142

Oščadnica, Slovakia

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Boehringer Ingelheim Investigational Site 157

Poprad, Slovakia

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Boehringer Ingelheim Investigational Site 128

Považská Bystrica, Slovakia

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Boehringer Ingelheim Investigational Site 132

Považský Chlmec, Slovakia

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Boehringer Ingelheim Investigational Site 118

Prešov, Slovakia

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Boehringer Ingelheim Investigational Site 138

Púchov, Slovakia

Location

Boehringer Ingelheim Investigational Site 143

Radoľa, Slovakia

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Boehringer Ingelheim Investigational Site 153

Rešov, Slovakia

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Boehringer Ingelheim Investigational Site 156

Revúca, Slovakia

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Boehringer Ingelheim Investigational Site 147

Rožkovany, Slovakia

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Boehringer Ingelheim Investigational Site 131

Rudinka, Slovakia

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Boehringer Ingelheim Investigational Site 126

Sabinov, Slovakia

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Boehringer Ingelheim Investigational Site 161

Skalité, Slovakia

Location

Boehringer Ingelheim Investigational Site 123

Spišská Nová Ves, Slovakia

Location

Boehringer Ingelheim Investigational Site 130

Stráňavy, Slovakia

Location

Boehringer Ingelheim Investigational Site 121

Trebišov, Slovakia

Location

Boehringer Ingelheim Investigational Site 151

Trnava, Slovakia

Location

Boehringer Ingelheim Investigational Site 129

Trnové, Slovakia

Location

Boehringer Ingelheim Investigational Site 135

Valasska Bela, Slovakia

Location

Boehringer Ingelheim Investigational Site 148

Vráble, Slovakia

Location

Boehringer Ingelheim Investigational Site 136

Zvolen, Slovakia

Location

Boehringer Ingelheim Investigational Site 133

Žilina, Slovakia

Location

Boehringer Ingelheim Investigational Site 23

Baleares, Spain

Location

Boehringer Ingelheim Investigational Site 22

Barcelona, Spain

Location

Boehringer Ingelheim Investigational Site 15

Ciudad Real, Spain

Location

Boehringer Ingelheim Investigational Site 16

Galicia, Spain

Location

Boehringer Ingelheim Investigational Site 17

Madrid, Spain

Location

Boehringer Ingelheim Investigational Site 18

Murcia, Spain

Location

Boehringer Ingelheim Investigational Site 19

Seville, Spain

Location

Boehringer Ingelheim Investigational Site 20

Valencia, Spain

Location

Boehringer Ingelheim Investigational Site 21

Zaragoza, Spain

Location

Boehringer Ingelheim Investigational Site 71

Brighton, United Kingdom

Location

Boehringer Ingelheim Investigational Site 76

Cheadle, United Kingdom

Location

Boehringer Ingelheim Investigational Site 78

Essex, United Kingdom

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Boehringer Ingelheim Investigational Site 70

London, United Kingdom

Location

Boehringer Ingelheim Investigational Site 77

Manchester, United Kingdom

Location

Boehringer Ingelheim Investigational Site 74

Middlesex, United Kingdom

Location

Boehringer Ingelheim Investigational Site 73

Romford, United Kingdom

Location

Boehringer Ingelheim Investigational Site 75

Stockport, United Kingdom

Location

Boehringer Ingelheim Investigational Site 72

Surrey, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2015
• First Posted: May 5, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 19, 2016
• Results First Posted: September 19, 2016

Record last verified: 2016-07

Locations

GB (9); SL (44); DE (14); DK (1); BU (10); FR (45); ES (9); CZ (29)