Clinical trial NCT02597920: Patient Convenience Study
Official title: Non-interventional Study Describing Patients' Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamin K Antagonist for Stroke Prophylaxis in Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2015-11-05
Enrollment: 1852
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: European patients with non valvular atrial fibrillation

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
timeFrame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
measure: Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
timeFrame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
measure: Patient Characterization at Baseline - Categorical Parameters
timeFrame: Baseline
measure: Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
timeFrame: Baseline
measure: Patient Characterization at Baseline - Creatinine Clearance
timeFrame: Baseline
measure: Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
timeFrame: Baseline
Secondary outcomes:
measure: Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
timeFrame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
measure: Description of PACT-Q1 Items for Patients in Cohort B at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Braine-l'Alleud
country: Belgium
facility: 1160.247.1019 Boehringer Ingelheim Investigational Site
city: Brussels
country: Belgium
facility: 1160.247.1020 Boehringer Ingelheim Investigational Site
city: Brussel
country: Belgium
facility: 1160.247.1018 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1160.247.1001 Boehringer Ingelheim Investigational Site
city: De Pinte
country: Belgium
facility: 1160.247.1013 Boehringer Ingelheim Investigational Site
city: Dendermonde
country: Belgium
facility: 1160.247.1010 Boehringer Ingelheim Investigational Site
city: Diest
country: Belgium
facility: 1160.247.1011 Boehringer Ingelheim Investigational Site
city: Edegem
country: Belgium
facility: 1160.247.1014 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1160.247.1007 Boehringer Ingelheim Investigational Site
city: Lier
country: Belgium
facility: 1160.247.1021 Boehringer Ingelheim Investigational Site
city: Maaseik
country: Belgium
facility: 1160.247.1002 Boehringer Ingelheim Investigational Site
city: Meise
country: Belgium
facility: 1160.247.1015 Boehringer Ingelheim Investigational Site
city: Mol
country: Belgium
facility: 1160.247.1008 Boehringer Ingelheim Investigational Site
city: Mol
country: Belgium
facility: 1160.247.1016 Boehringer Ingelheim Investigational Site
city: Mons
country: Belgium
facility: 1160.247.1005 Boehringer Ingelheim Investigational Site
city: Nijlen
country: Belgium
facility: 1160.247.1009 Boehringer Ingelheim Investigational Site
city: Ottignies - Louvain-la-neuve
country: Belgium
facility: 1160.247.1003 Boehringer Ingelheim Investigational Site
city: Roeselare
country: Belgium
facility: 1160.247.1012 Boehringer Ingelheim Investigational Site
city: Tienen
country: Belgium
facility: 1160.247.1017 Boehringer Ingelheim Investigational Site
city: Frederikssund
country: Denmark
facility: 1160.247.2006 Boehringer Ingelheim Investigational Site
city: Herning
country: Denmark
facility: 1160.247.2008 Boehringer Ingelheim Investigational Site
city: Hjørring
country: Denmark
facility: 1160.247.2001 Sygehus Vendsyssel
city: Hvidovre
country: Denmark
facility: 1160.247.2007 Hvidovre Hospital
city: Nykøbing F
country: Denmark
facility: 1160.247.2005 Boehringer Ingelheim Investigational Site
city: Næstved
country: Denmark
facility: 1160.247.2003 Boehringer Ingelheim Investigational Site
city: Roskilde
country: Denmark
facility: 1160.247.2009 Boehringer Ingelheim Investigational Site
city: Svendborg
country: Denmark
facility: 1160.247.2004 Boehringer Ingelheim Investigational Site
city: Agrinio
country: Greece
facility: 1160.247.3410 Boehringer Ingelheim Investigational Site
city: Alexandroupoli
country: Greece
facility: 1160.247.3306 Boehringer Ingelheim Investigational Site
city: Arta
country: Greece
facility: 1160.247.3411 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3100 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3101 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3102 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3103 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3104 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3105 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3106 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3107 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3108 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3109 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3110 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3111 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3113 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3114 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3116 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3118 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3119 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3120 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3121 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3122 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3200 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3202 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3203 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3204 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3206 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3207 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3208 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3211 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3212 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3213 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3214 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3217 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.247.3218 Boehringer Ingelheim Investigational Site
city: Chalkidiki
country: Greece
facility: 1160.247.3316 Boehringer Ingelheim Investigational Site
city: Chania
country: Greece
facility: 1160.247.3219 Boehringer Ingelheim Investigational Site
city: Drama
country: Greece
facility: 1160.247.3315 Boehringer Ingelheim Investigational Site
city: Giannitsa
country: Greece
facility: 1160.247.3307 Boehringer Ingelheim Investigational Site
city: Glyfada, Athens
country: Greece
facility: 1160.247.3216 Boehringer Ingelheim Investigational Site
city: Hrakleion ,Crete
country: Greece
facility: 1160.247.3215 Boehringer Ingelheim Investigational Site
city: Ierapetra, Crete
country: Greece
facility: 1160.247.3201 Boehringer Ingelheim Investigational Site
city: Ioannina
country: Greece
facility: 1160.247.3400 Boehringer Ingelheim Investigational Site
city: Ioannina
country: Greece
facility: 1160.247.3408 Boehringer Ingelheim Investigational Site
city: Ioannina
country: Greece
facility: 1160.247.3409 Boehringer Ingelheim Investigational Site
city: Kalamata
country: Greece
facility: 1160.247.3402 Boehringer Ingelheim Investigational Site
city: Karditsa
country: Greece
facility: 1160.247.3407 Boehringer Ingelheim Investigational Site
city: Katerini
country: Greece
facility: 1160.247.3318 Boehringer Ingelheim Investigational Site
city: Kavala
country: Greece
facility: 1160.247.3312 Boehringer Ingelheim Investigational Site
city: Kerkyra
country: Greece
facility: 1160.247.3404 Boehringer Ingelheim Investigational Site
city: Komotini
country: Greece
facility: 1160.247.3320 V.Pavlou 21 , Komotini
city: Larissa
country: Greece
facility: 1160.247.3415 Boehringer Ingelheim Investigational Site
city: Patra
country: Greece
facility: 1160.247.3412 Boehringer Ingelheim Investigational Site
city: Patra
country: Greece
facility: 1160.247.3416 Boehringer Ingelheim Investigational Site
city: Serres
country: Greece
facility: 1160.247.3317 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3300 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3301 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3303 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3304 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3305 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3308 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3309 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3313 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3314 Boehringer Ingelheim Investigational Site
city: Thessaloniki
country: Greece
facility: 1160.247.3319 Boehringer Ingelheim Investigational Site
city: Trikala
country: Greece
facility: 1160.247.3406 Boehringer Ingelheim Investigational Site
city: Tripoli
country: Greece
facility: 1160.247.3403 Boehringer Ingelheim Investigational Site
city: Veroia
country: Greece
facility: 1160.247.3310 Boehringer Ingelheim Investigational Site
city: Volos
country: Greece
facility: 1160.247.3401 Boehringer Ingelheim Investigational Site
city: Xanthi
country: Greece
facility: 1160.247.3405 Boehringer Ingelheim Investigational Site
city: Xilokastro
country: Greece
facility: 1160.247.3413 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.247.4004 Boehringer Ingelheim Investigational Site
city: Beugen
country: Netherlands
facility: 1160.247.4010 Boehringer Ingelheim Investigational Site
city: Capelle A/d Ijssel
country: Netherlands
facility: 1160.247.4013 Boehringer Ingelheim Investigational Site
city: Den Haag
country: Netherlands
facility: 1160.247.4002 Boehringer Ingelheim Investigational Site
city: EDE
country: Netherlands
facility: 1160.247.4006 Boehringer Ingelheim Investigational Site
city: Goes
country: Netherlands
facility: 1160.247.4009 Boehringer Ingelheim Investigational Site
city: Groningen
country: Netherlands
facility: 1160.247.4001 Boehringer Ingelheim Investigational Site
city: Heerenveen
country: Netherlands
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city: Heerlen
country: Netherlands
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country: Netherlands
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city: Schiedam
country: Netherlands
facility: 1160.247.4011 Boehringer Ingelheim Investigational Site
city: Uden
country: Netherlands
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city: Veldhoven
country: Netherlands
facility: 1160.247.4003 Boehringer Ingelheim Investigational Site
city: Bergen
country: Norway
facility: 1160.247.5001 Boehringer Ingelheim Investigational Site
city: Førde
country: Norway
facility: 1160.247.5007 Boehringer Ingelheim Investigational Site
city: Lierskogen
country: Norway
facility: 1160.247.5008 Boehringer Ingelheim Investigational Site
city: Nesbru
country: Norway
facility: 1160.247.5009 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.247.5004 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.247.5005 Boehringer Ingelheim Investigational Site
city: Stavanger
country: Norway
facility: 1160.247.5010 Boehringer Ingelheim Investigational Site
city: Svelvik
country: Norway
facility: 1160.247.5006 Boehringer Ingelheim Investigational Site
city: Amadora
country: Portugal
facility: 1160.247.6003 Boehringer Ingelheim Investigational Site
city: Angra do Heroísmo
country: Portugal
facility: 1160.247.6012 Boehringer Ingelheim Investigational Site
city: Aveiro
country: Portugal
facility: 1160.247.6007 Boehringer Ingelheim Investigational Site
city: Braga
country: Portugal
facility: 1160.247.6004 Boehringer Ingelheim Investigational Site
city: Guimarães
country: Portugal
facility: 1160.247.6006 Boehringer Ingelheim Investigational Site
city: Horta
country: Portugal
facility: 1160.247.6013 Boehringer Ingelheim Investigational Site
city: Matosinhos
country: Portugal
facility: 1160.247.6002 Boehringer Ingelheim Investigational Site
city: Penafiel
country: Portugal
facility: 1160.247.6009 Boehringer Ingelheim Investigational Site
city: Viana do Castelo
country: Portugal
facility: 1160.247.6008 Boehringer Ingelheim Investigational Site
city: Vila Franca de Xira
country: Portugal
facility: 1160.247.6005 Boehringer Ingelheim Investigational Site
city: Bandhagen
country: Sweden
facility: 1160.247.7016 Boehringer Ingelheim Investigational Site
city: Broby
country: Sweden
facility: 1160.247.7013 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.247.7006 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.247.7007 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.247.7014 Boehringer Ingelheim Investigational Site
city: Hässleholm
country: Sweden
facility: 1160.247.7011 Boehringer Ingelheim Investigational Site
city: Kristianstad
country: Sweden
facility: 1160.247.7019 Boehringer Ingelheim Investigational Site
city: Malmö
country: Sweden
facility: 1160.247.7005 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7002 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7003 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7004 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7008 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7010 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7012 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.247.7017 Boehringer Ingelheim Investigational Site
city: Värnamo
country: Sweden
facility: 1160.247.7009 Boehringer Ingelheim Investigational Site
city: Västerås
country: Sweden
facility: 1160.247.7015 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: