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

July 28, 2016 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Purpose:

Study Type

Observational

Enrollment (Actual)

1213

Contacts and Locations

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

Study Locations

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

Participation Criteria

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

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Physicians prescribing dabigatran for patients with atrial fibrillation

Description

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®

Study Plan

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

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Physicians

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physician's Knowledge and Recommendations to Their Patients on Appropriate Dosing and Minimizing the Risk of Bleeding When Treated With Pradaxa® (Questionnaire)
Time Frame: Day 1

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)
Time Frame: Day 1
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

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

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

Helpful Links

Study record dates

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

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

March 25, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (Estimate)

May 5, 2015

Study Record Updates

Last Update Posted (Estimate)

September 19, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1160.149

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

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