Atrial Fibrillation Clinical Trial
Official title:
Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF
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.
| Status | Completed |
| Enrollment | 1213 |
| Est. completion date | August 2015 |
| Est. primary completion date | August 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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® |
Observational Model: Cohort, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Bulgaria | Boehringer Ingelheim Investigational Site 81 | Dobritch | |
| Bulgaria | Boehringer Ingelheim Investigational Site 84 | Gabrovo | |
| Bulgaria | Boehringer Ingelheim Investigational Site 79 | Montana | |
| Bulgaria | Boehringer Ingelheim Investigational Site 85 | Plovdiv | |
| Bulgaria | Boehringer Ingelheim Investigational Site 80 | Shumen | |
| Bulgaria | Boehringer Ingelheim Investigational Site 86 | Sliven | |
| Bulgaria | Boehringer Ingelheim Investigational Site 87 | Sofia | |
| Bulgaria | Boehringer Ingelheim Investigational Site 88 | Stara Zagora | |
| Bulgaria | Boehringer Ingelheim Investigational Site 82 | Varna | |
| Bulgaria | Boehringer Ingelheim Investigational Site 83 | Veliko Tarnovo | |
| Czech Republic | Boehringer Ingelheim Investigational Site 92 | ?eská Lípa | |
| Czech Republic | Boehringer Ingelheim Investigational Site 93 | ?eské Bud?jovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 94 | ?eský Krumlov | |
| Czech Republic | Boehringer Ingelheim Investigational Site 90 | B?eclav | |
| Czech Republic | Boehringer Ingelheim Investigational Site 89 | Benesov u Prahy | |
| Czech Republic | Boehringer Ingelheim Investigational Site 91 | Brno | |
| Czech Republic | Boehringer Ingelheim Investigational Site 95 | Chomutov | |
| Czech Republic | Boehringer Ingelheim Investigational Site 96 | Domazlice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 97 | Haví?ov | |
| Czech Republic | Boehringer Ingelheim Investigational Site 98 | Havlí?k?v Brod | |
| Czech Republic | Boehringer Ingelheim Investigational Site 99 | Ho?ovice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 100 | Hradec Králové | |
| Czech Republic | Boehringer Ingelheim Investigational Site 101 | Ivan?ice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 102 | Krom??íz | |
| Czech Republic | Boehringer Ingelheim Investigational Site 103 | Kyjov | |
| Czech Republic | Boehringer Ingelheim Investigational Site 104 | Liberec | |
| Czech Republic | Boehringer Ingelheim Investigational Site 105 | Louny | |
| Czech Republic | Boehringer Ingelheim Investigational Site 106 | Most | |
| Czech Republic | Boehringer Ingelheim Investigational Site 107 | Nový Bor | |
| Czech Republic | Boehringer Ingelheim Investigational Site 108 | Odry | |
| Czech Republic | Boehringer Ingelheim Investigational Site 109 | Olomouc | |
| Czech Republic | Boehringer Ingelheim Investigational Site 110 | Pardubice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 111 | Plze? | |
| Czech Republic | Boehringer Ingelheim Investigational Site 112 | Praha | |
| Czech Republic | Boehringer Ingelheim Investigational Site 113 | Sternberk | |
| Czech Republic | Boehringer Ingelheim Investigational Site 114 | Tábor | |
| Czech Republic | Boehringer Ingelheim Investigational Site 115 | Tehovec | |
| Czech Republic | Boehringer Ingelheim Investigational Site 116 | Teplice | |
| Czech Republic | Boehringer Ingelheim Investigational Site 117 | Valasské Mezi?í?í | |
| Denmark | Boehringer Ingelheim Investigational Site 69 | Copenhagen | |
| France | Boehringer Ingelheim Investigational Site 25 | Ambleuteuse | |
| France | Boehringer Ingelheim Investigational Site 68 | Ardres | |
| France | Boehringer Ingelheim Investigational Site 26 | Arnac pompadour | |
| France | Boehringer Ingelheim Investigational Site 27 | Audincourt | |
| France | Boehringer Ingelheim Investigational Site 28 | Bart | |
| France | Boehringer Ingelheim Investigational Site 29 | Besançon | |
| France | Boehringer Ingelheim Investigational Site 30 | Buissière galant | |
| France | Boehringer Ingelheim Investigational Site 32 | Chalus | |
| France | Boehringer Ingelheim Investigational Site 31 | Charbrignac | |
| France | Boehringer Ingelheim Investigational Site 33 | Coussac Bonneval | |
| France | Boehringer Ingelheim Investigational Site 34 | Decines | |
| France | Boehringer Ingelheim Investigational Site 35 | Eckwersheim | |
| France | Boehringer Ingelheim Investigational Site 36 | Geneuille | |
| France | Boehringer Ingelheim Investigational Site 37 | Glandon | |
| France | Boehringer Ingelheim Investigational Site 65 | Gruson | |
| France | Boehringer Ingelheim Investigational Site 38 | Halluin | |
| France | Boehringer Ingelheim Investigational Site 39 | Lanouaille | |
| France | Boehringer Ingelheim Investigational Site 67 | Le catelet | |
| France | Boehringer Ingelheim Investigational Site 40 | Le Haillan | |
| France | Boehringer Ingelheim Investigational Site 41 | Lille | |
| France | Boehringer Ingelheim Investigational Site 42 | Limoges | |
| France | Boehringer Ingelheim Investigational Site 43 | Lomme | |
| France | Boehringer Ingelheim Investigational Site 44 | Lyon | |
| France | Boehringer Ingelheim Investigational Site 45 | Marseille | |
| France | Boehringer Ingelheim Investigational Site 46 | Merignac | |
| France | Boehringer Ingelheim Investigational Site 47 | Nexon | |
| France | Boehringer Ingelheim Investigational Site 48 | Noaillan | |
| France | Boehringer Ingelheim Investigational Site 24 | Paris | |
| France | Boehringer Ingelheim Investigational Site 49 | Pompadour | |
| France | Boehringer Ingelheim Investigational Site 50 | Saint Martial d'Albarede | |
| France | Boehringer Ingelheim Investigational Site 51 | Saint Martin Sepert | |
| France | Boehringer Ingelheim Investigational Site 52 | Saint Saud Lacousserie | |
| France | Boehringer Ingelheim Investigational Site 53 | Saint Sornin Lavolps | |
| France | Boehringer Ingelheim Investigational Site 54 | Saint Yrieix la Perche | |
| France | Boehringer Ingelheim Investigational Site 55 | Saint-Hilaire-les-Places | |
| France | Boehringer Ingelheim Investigational Site 56 | Schiltigheim | |
| France | Boehringer Ingelheim Investigational Site 57 | Sochaux | |
| France | Boehringer Ingelheim Investigational Site 58 | Strasbourg | |
| France | Boehringer Ingelheim Investigational Site 59 | Talence | |
| France | Boehringer Ingelheim Investigational Site 60 | Thiviers | |
| France | Boehringer Ingelheim Investigational Site 66 | Tourcoing | |
| France | Boehringer Ingelheim Investigational Site 61 | Tourmignies | |
| France | Boehringer Ingelheim Investigational Site 62 | Villenave d'Ornon | |
| France | Boehringer Ingelheim Investigational Site 63 | Voujeaucourt | |
| France | Boehringer Ingelheim Investigational Site 64 | Weyersheim | |
| Germany | Boehringer Ingelheim Investigational Site 9 | Berlin | |
| Germany | Boehringer Ingelheim Investigational Site 3 | Bremen | |
| Germany | Boehringer Ingelheim Investigational Site 10 | Chemnitz | |
| Germany | Boehringer Ingelheim Investigational Site 5 | Düsseldorf | |
| Germany | Boehringer Ingelheim Investigational Site 6 | Essen | |
| Germany | Boehringer Ingelheim Investigational Site 1 | Frankfurt | |
| Germany | Boehringer Ingelheim Investigational Site 8 | Hannover | |
| Germany | Boehringer Ingelheim Investigational Site 14 | Heidelberg | |
| Germany | Boehringer Ingelheim Investigational Site 11 | Leipzig | |
| Germany | Boehringer Ingelheim Investigational Site 2 | Mannheim | |
| Germany | Boehringer Ingelheim Investigational Site 7 | Marburg | |
| Germany | Boehringer Ingelheim Investigational Site 13 | München | |
| Germany | Boehringer Ingelheim Investigational Site 4 | Nürnberg | |
| Germany | Boehringer Ingelheim Investigational Site 12 | Rostock | |
| Slovakia | Boehringer Ingelheim Investigational Site 122 | Banska Bystrica | |
| Slovakia | Boehringer Ingelheim Investigational Site 127 | Bardejov | |
| Slovakia | Boehringer Ingelheim Investigational Site 152 | Bratislava | |
| Slovakia | Boehringer Ingelheim Investigational Site 146 | Cierna nad Tisou | |
| Slovakia | Boehringer Ingelheim Investigational Site 149 | Cierne Klacany | |
| Slovakia | Boehringer Ingelheim Investigational Site 154 | Cierny Brod | |
| Slovakia | Boehringer Ingelheim Investigational Site 139 | Dolne Kockovce | |
| Slovakia | Boehringer Ingelheim Investigational Site 141 | Horny Vadicov | |
| Slovakia | Boehringer Ingelheim Investigational Site 137 | Ivanka pri Dunaji | |
| Slovakia | Boehringer Ingelheim Investigational Site 140 | Jelka | |
| Slovakia | Boehringer Ingelheim Investigational Site 159 | Kokava nad Rimavicou | |
| Slovakia | Boehringer Ingelheim Investigational Site 125 | Kosice | |
| Slovakia | Boehringer Ingelheim Investigational Site 158 | Kostany nad Turcom | |
| Slovakia | Boehringer Ingelheim Investigational Site 160 | Krasno nad Kysucou | |
| Slovakia | Boehringer Ingelheim Investigational Site 134 | Lalinok | |
| Slovakia | Boehringer Ingelheim Investigational Site 120 | Lastovce | |
| Slovakia | Boehringer Ingelheim Investigational Site 155 | Liptovsky Hradok | |
| Slovakia | Boehringer Ingelheim Investigational Site 145 | Lucenec | |
| Slovakia | Boehringer Ingelheim Investigational Site 144 | Nitra | |
| Slovakia | Boehringer Ingelheim Investigational Site 119 | Nove Mesto nad Vahom | |
| Slovakia | Boehringer Ingelheim Investigational Site 150 | Nove Zamky | |
| Slovakia | Boehringer Ingelheim Investigational Site 124 | Odorin | |
| Slovakia | Boehringer Ingelheim Investigational Site 142 | Oscadnica | |
| Slovakia | Boehringer Ingelheim Investigational Site 157 | Poprad | |
| Slovakia | Boehringer Ingelheim Investigational Site 128 | Povazska Bystrica | |
| Slovakia | Boehringer Ingelheim Investigational Site 132 | Povazsky Chlmec | |
| Slovakia | Boehringer Ingelheim Investigational Site 118 | Presov | |
| Slovakia | Boehringer Ingelheim Investigational Site 138 | Puchov | |
| Slovakia | Boehringer Ingelheim Investigational Site 143 | Radola | |
| Slovakia | Boehringer Ingelheim Investigational Site 153 | Resov | |
| Slovakia | Boehringer Ingelheim Investigational Site 156 | Revuca | |
| Slovakia | Boehringer Ingelheim Investigational Site 147 | Rozkovany | |
| Slovakia | Boehringer Ingelheim Investigational Site 131 | Rudinka | |
| Slovakia | Boehringer Ingelheim Investigational Site 126 | Sabinov | |
| Slovakia | Boehringer Ingelheim Investigational Site 161 | Skalite | |
| Slovakia | Boehringer Ingelheim Investigational Site 123 | Spisska Nova Ves | |
| Slovakia | Boehringer Ingelheim Investigational Site 130 | Stranavy | |
| Slovakia | Boehringer Ingelheim Investigational Site 121 | Trebisov | |
| Slovakia | Boehringer Ingelheim Investigational Site 151 | Trnava | |
| Slovakia | Boehringer Ingelheim Investigational Site 129 | Trnove | |
| Slovakia | Boehringer Ingelheim Investigational Site 135 | Valasska Bela | |
| Slovakia | Boehringer Ingelheim Investigational Site 148 | Vrable | |
| Slovakia | Boehringer Ingelheim Investigational Site 133 | Zilina | |
| Slovakia | Boehringer Ingelheim Investigational Site 136 | Zvolen | |
| Spain | Boehringer Ingelheim Investigational Site 23 | Baleares | |
| Spain | Boehringer Ingelheim Investigational Site 22 | Barcelona | |
| Spain | Boehringer Ingelheim Investigational Site 15 | Ciudad Real | |
| Spain | Boehringer Ingelheim Investigational Site 16 | Galicia | |
| Spain | Boehringer Ingelheim Investigational Site 17 | Madrid | |
| Spain | Boehringer Ingelheim Investigational Site 18 | Murcia | |
| Spain | Boehringer Ingelheim Investigational Site 19 | Sevilla | |
| Spain | Boehringer Ingelheim Investigational Site 20 | Valencia | |
| Spain | Boehringer Ingelheim Investigational Site 21 | Zaragoza | |
| United Kingdom | Boehringer Ingelheim Investigational Site 71 | Brighton | |
| United Kingdom | Boehringer Ingelheim Investigational Site 76 | Cheadle | |
| United Kingdom | Boehringer Ingelheim Investigational Site 78 | Essex | |
| United Kingdom | Boehringer Ingelheim Investigational Site 70 | London | |
| United Kingdom | Boehringer Ingelheim Investigational Site 77 | Manchester | |
| United Kingdom | Boehringer Ingelheim Investigational Site 74 | Middlesex | |
| United Kingdom | Boehringer Ingelheim Investigational Site 73 | Romford | |
| United Kingdom | Boehringer Ingelheim Investigational Site 75 | Stockport | |
| United Kingdom | Boehringer Ingelheim Investigational Site 72 | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Bulgaria, Czech Republic, Denmark, France, Germany, Slovakia, Spain, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Physician`s knowledge and recommendations to their patients on appropriate dosing and minimizing the risk of bleeding when treated with Pradaxa® (questionnaire) | day 1 | Yes | |
| Primary | 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) | day 1 | Yes |
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