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Patient Convenience Study

NCT ID: NCT02597920

Last Updated: 2019-02-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1852 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-11

Study Completion Date

2017-01-30

Brief Summary

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The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa® to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

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Detailed Description

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Conditions

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Atrial Fibrillation

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Switch patients / A

Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.

No interventions assigned to this group

New AF patients / B

Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

Cohort A:

1. A. Written informed consent prior to participation
2. A. Female and male patients \>= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
3. A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
4. A. Patients switched to Pradaxa® according Summary of Product Characteristics and physician's discretion.

OR

Cohort B:

1. B. Written informed consent prior to participation.
2. B. Female and male patients \>= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
3. B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Exclusion Criteria

1. Contraindication to the use of Pradaxa® or VKA as described in the Summary of Product Characteristics (SmPC).
2. Patients receiving Pradaxa® or VKA for any other condition than stroke prevention in atrial fibrillation.
3. Current participation in any clinical trial of a drug or device.
4. Current participation in an European registry on the use of oral anticoagulation in AF.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1160.247.1019 Boehringer Ingelheim Investigational Site

Braine-l'Alleud, , Belgium

Site Status

1160.247.1001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1160.247.1018 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1160.247.1020 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1160.247.1013 Boehringer Ingelheim Investigational Site

De Pinte, , Belgium

Site Status

1160.247.1010 Boehringer Ingelheim Investigational Site

Dendermonde, , Belgium

Site Status

1160.247.1011 Boehringer Ingelheim Investigational Site

Diest, , Belgium

Site Status

1160.247.1014 Boehringer Ingelheim Investigational Site

Edegem, , Belgium

Site Status

1160.247.1007 Boehringer Ingelheim Investigational Site

Leuven, , Belgium

Site Status

1160.247.1021 Boehringer Ingelheim Investigational Site

Lier, , Belgium

Site Status

1160.247.1002 Boehringer Ingelheim Investigational Site

Maaseik, , Belgium

Site Status

1160.247.1015 Boehringer Ingelheim Investigational Site

Meise, , Belgium

Site Status

1160.247.1008 Boehringer Ingelheim Investigational Site

Mol, , Belgium

Site Status

1160.247.1016 Boehringer Ingelheim Investigational Site

Mol, , Belgium

Site Status

1160.247.1005 Boehringer Ingelheim Investigational Site

Mons, , Belgium

Site Status

1160.247.1009 Boehringer Ingelheim Investigational Site

Nijlen, , Belgium

Site Status

1160.247.1003 Boehringer Ingelheim Investigational Site

Ottignies-Louvain-la-Neuve, , Belgium

Site Status

1160.247.1012 Boehringer Ingelheim Investigational Site

Roeselare, , Belgium

Site Status

1160.247.1017 Boehringer Ingelheim Investigational Site

Tienen, , Belgium

Site Status

1160.247.2006 Boehringer Ingelheim Investigational Site

Frederikssund, , Denmark

Site Status

1160.247.2008 Boehringer Ingelheim Investigational Site

Herning, , Denmark

Site Status

1160.247.2001 Sygehus Vendsyssel

Hjørring, , Denmark

Site Status

1160.247.2007 Hvidovre Hospital

Hvidovre, , Denmark

Site Status

1160.247.2005 Boehringer Ingelheim Investigational Site

Nykøbing Falster, , Denmark

Site Status

1160.247.2003 Boehringer Ingelheim Investigational Site

Næstved, , Denmark

Site Status

1160.247.2009 Boehringer Ingelheim Investigational Site

Roskilde, , Denmark

Site Status

1160.247.2004 Boehringer Ingelheim Investigational Site

Svendborg, , Denmark

Site Status

1160.247.3410 Boehringer Ingelheim Investigational Site

Agrinio, , Greece

Site Status

1160.247.3306 Boehringer Ingelheim Investigational Site

Alexandroupoli, , Greece

Site Status

1160.247.3411 Boehringer Ingelheim Investigational Site

Arta, , Greece

Site Status

1160.247.3100 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3101 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3102 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3103 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3104 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3105 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3106 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3107 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3108 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3109 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3110 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3111 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3113 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3114 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3116 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3118 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3119 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3120 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3121 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3122 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3200 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3202 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3203 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3204 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3206 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3207 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3208 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3211 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3212 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3213 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3214 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3217 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3218 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1160.247.3316 Boehringer Ingelheim Investigational Site

Chalkidiki, , Greece

Site Status

1160.247.3219 Boehringer Ingelheim Investigational Site

Chania, , Greece

Site Status

1160.247.3404 Boehringer Ingelheim Investigational Site

Corfu, , Greece

Site Status

1160.247.3315 Boehringer Ingelheim Investigational Site

Drama, , Greece

Site Status

1160.247.3307 Boehringer Ingelheim Investigational Site

Giannitsá, , Greece

Site Status

1160.247.3216 Boehringer Ingelheim Investigational Site

Glyfada, Athens, , Greece

Site Status

1160.247.3215 Boehringer Ingelheim Investigational Site

Hrakleion ,Crete, , Greece

Site Status

1160.247.3201 Boehringer Ingelheim Investigational Site

Ierapetra, Crete, , Greece

Site Status

1160.247.3400 Boehringer Ingelheim Investigational Site

Ioannina, , Greece

Site Status

1160.247.3408 Boehringer Ingelheim Investigational Site

Ioannina, , Greece

Site Status

1160.247.3409 Boehringer Ingelheim Investigational Site

Ioannina, , Greece

Site Status

1160.247.3402 Boehringer Ingelheim Investigational Site

Kalamata, , Greece

Site Status

1160.247.3407 Boehringer Ingelheim Investigational Site

Karditsa, , Greece

Site Status

1160.247.3318 Boehringer Ingelheim Investigational Site

Katerini, , Greece

Site Status

1160.247.3312 Boehringer Ingelheim Investigational Site

Kavala, , Greece

Site Status

1160.247.3320 V.Pavlou 21 , Komotini

Komotini, , Greece

Site Status

1160.247.3415 Boehringer Ingelheim Investigational Site

Larissa, , Greece

Site Status

1160.247.3412 Boehringer Ingelheim Investigational Site

Pátrai, , Greece

Site Status

1160.247.3416 Boehringer Ingelheim Investigational Site

Pátrai, , Greece

Site Status

1160.247.3317 Boehringer Ingelheim Investigational Site

Serres, , Greece

Site Status

1160.247.3300 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3301 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3303 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3304 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3305 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3308 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3309 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3313 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3314 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3319 Boehringer Ingelheim Investigational Site

Thessaloniki, , Greece

Site Status

1160.247.3406 Boehringer Ingelheim Investigational Site

Trikala, , Greece

Site Status

1160.247.3403 Boehringer Ingelheim Investigational Site

Tripoli, , Greece

Site Status

1160.247.3310 Boehringer Ingelheim Investigational Site

Véroia, , Greece

Site Status

1160.247.3401 Boehringer Ingelheim Investigational Site

Volos, , Greece

Site Status

1160.247.3405 Boehringer Ingelheim Investigational Site

Xánthi, , Greece

Site Status

1160.247.3413 Boehringer Ingelheim Investigational Site

Xilokastro, , Greece

Site Status

1160.247.4004 Boehringer Ingelheim Investigational Site

Amsterdam, , Netherlands

Site Status

1160.247.4010 Boehringer Ingelheim Investigational Site

Beugen, , Netherlands

Site Status

1160.247.4013 Boehringer Ingelheim Investigational Site

Capelle aan den IJssel, , Netherlands

Site Status

1160.247.4006 Boehringer Ingelheim Investigational Site

Ede, , Netherlands

Site Status

1160.247.4009 Boehringer Ingelheim Investigational Site

Goes, , Netherlands

Site Status

1160.247.4001 Boehringer Ingelheim Investigational Site

Groningen, , Netherlands

Site Status

1160.247.4008 Boehringer Ingelheim Investigational Site

Heerenveen, , Netherlands

Site Status

1160.247.4012 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1160.247.4005 Boehringer Ingelheim Investigational Site

Nijmegen, , Netherlands

Site Status

1160.247.4011 Boehringer Ingelheim Investigational Site

Schiedam, , Netherlands

Site Status

1160.247.4002 Boehringer Ingelheim Investigational Site

The Hague, , Netherlands

Site Status

1160.247.4007 Boehringer Ingelheim Investigational Site

Uden, , Netherlands

Site Status

1160.247.4003 Boehringer Ingelheim Investigational Site

Veldhoven, , Netherlands

Site Status

1160.247.5001 Boehringer Ingelheim Investigational Site

Bergen, , Norway

Site Status

1160.247.5007 Boehringer Ingelheim Investigational Site

Førde, , Norway

Site Status

1160.247.5008 Boehringer Ingelheim Investigational Site

Lierskogen, , Norway

Site Status

1160.247.5009 Boehringer Ingelheim Investigational Site

Nesbru, , Norway

Site Status

1160.247.5004 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1160.247.5005 Boehringer Ingelheim Investigational Site

Oslo, , Norway

Site Status

1160.247.5010 Boehringer Ingelheim Investigational Site

Stavanger, , Norway

Site Status

1160.247.5006 Boehringer Ingelheim Investigational Site

Svelvik, , Norway

Site Status

1160.247.6003 Boehringer Ingelheim Investigational Site

Amadora, , Portugal

Site Status

1160.247.6012 Boehringer Ingelheim Investigational Site

Angra do Heroísmo, , Portugal

Site Status

1160.247.6007 Boehringer Ingelheim Investigational Site

Aveiro, , Portugal

Site Status

1160.247.6004 Boehringer Ingelheim Investigational Site

Braga, , Portugal

Site Status

1160.247.6006 Boehringer Ingelheim Investigational Site

Guimarães, , Portugal

Site Status

1160.247.6013 Boehringer Ingelheim Investigational Site

Horta, , Portugal

Site Status

1160.247.6002 Boehringer Ingelheim Investigational Site

Matosinhos Municipality, , Portugal

Site Status

1160.247.6009 Boehringer Ingelheim Investigational Site

Penafiel, , Portugal

Site Status

1160.247.6008 Boehringer Ingelheim Investigational Site

Viana do Castelo, , Portugal

Site Status

1160.247.6005 Boehringer Ingelheim Investigational Site

Vila Franca de Xira, , Portugal

Site Status

1160.247.7016 Boehringer Ingelheim Investigational Site

Bandhagen, , Sweden

Site Status

1160.247.7013 Boehringer Ingelheim Investigational Site

Broby, , Sweden

Site Status

1160.247.7006 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.247.7007 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.247.7014 Boehringer Ingelheim Investigational Site

Gothenburg, , Sweden

Site Status

1160.247.7011 Boehringer Ingelheim Investigational Site

Hässleholm, , Sweden

Site Status

1160.247.7019 Boehringer Ingelheim Investigational Site

Kristianstad, , Sweden

Site Status

1160.247.7005 Boehringer Ingelheim Investigational Site

Malmo, , Sweden

Site Status

1160.247.7001 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7002 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7003 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7004 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7008 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7010 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7012 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7017 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

1160.247.7009 Boehringer Ingelheim Investigational Site

Värnamo, , Sweden

Site Status

1160.247.7015 Boehringer Ingelheim Investigational Site

Västerås, , Sweden

Site Status

Countries

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Belgium Denmark Greece Netherlands Norway Portugal Sweden

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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1160.247

Identifier Type: -

Identifier Source: org_study_id

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