Patient Convenience Study

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 148 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 1,852 participants
Where: 148 sitesin 7 countries
Study dates: 11 Nov 2015to 30 Jan 2017
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: European patients with non valvular atrial fibrillation

Who may be able to join

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

Show all 10Show fewer

Cohort B:
B. Written informed consent prior to participation.
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).
B. Stroke prevention treatment initiated with Pradaxa® or VKA according to Summary of Product Characteristics and physician's discretion.

Who cannot join

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

Trial locations and contacts

148 sites in 7 countries.

Country

City, postcode or hospital

148 sites in 7 countries

Greece72 sites

1160.247.3410 Boehringer Ingelheim Investigational Site
Agrinio
1160.247.3306 Boehringer Ingelheim Investigational Site
Alexandroupoli
1160.247.3411 Boehringer Ingelheim Investigational Site
Arta
1160.247.3100 Boehringer Ingelheim Investigational Site
Athens
1160.247.3101 Boehringer Ingelheim Investigational Site
Athens
1160.247.3102 Boehringer Ingelheim Investigational Site
Athens
1160.247.3103 Boehringer Ingelheim Investigational Site
Athens
1160.247.3104 Boehringer Ingelheim Investigational Site
Athens
1160.247.3105 Boehringer Ingelheim Investigational Site
Athens
1160.247.3106 Boehringer Ingelheim Investigational Site
Athens
1160.247.3107 Boehringer Ingelheim Investigational Site
Athens
1160.247.3108 Boehringer Ingelheim Investigational Site
Athens
1160.247.3109 Boehringer Ingelheim Investigational Site
Athens
1160.247.3110 Boehringer Ingelheim Investigational Site
Athens
1160.247.3111 Boehringer Ingelheim Investigational Site
Athens
1160.247.3113 Boehringer Ingelheim Investigational Site
Athens
1160.247.3114 Boehringer Ingelheim Investigational Site
Athens
1160.247.3116 Boehringer Ingelheim Investigational Site
Athens
1160.247.3118 Boehringer Ingelheim Investigational Site
Athens
1160.247.3119 Boehringer Ingelheim Investigational Site
Athens
1160.247.3120 Boehringer Ingelheim Investigational Site
Athens
1160.247.3121 Boehringer Ingelheim Investigational Site
Athens
1160.247.3122 Boehringer Ingelheim Investigational Site
Athens
1160.247.3200 Boehringer Ingelheim Investigational Site
Athens
1160.247.3202 Boehringer Ingelheim Investigational Site
Athens
1160.247.3203 Boehringer Ingelheim Investigational Site
Athens
1160.247.3204 Boehringer Ingelheim Investigational Site
Athens
1160.247.3206 Boehringer Ingelheim Investigational Site
Athens
1160.247.3207 Boehringer Ingelheim Investigational Site
Athens
1160.247.3208 Boehringer Ingelheim Investigational Site
Athens
1160.247.3211 Boehringer Ingelheim Investigational Site
Athens
1160.247.3212 Boehringer Ingelheim Investigational Site
Athens
1160.247.3213 Boehringer Ingelheim Investigational Site
Athens
1160.247.3214 Boehringer Ingelheim Investigational Site
Athens
1160.247.3217 Boehringer Ingelheim Investigational Site
Athens
1160.247.3218 Boehringer Ingelheim Investigational Site
Athens
1160.247.3316 Boehringer Ingelheim Investigational Site
Chalkidiki
1160.247.3219 Boehringer Ingelheim Investigational Site
Chania
1160.247.3404 Boehringer Ingelheim Investigational Site
Corfu
1160.247.3315 Boehringer Ingelheim Investigational Site
Drama
1160.247.3307 Boehringer Ingelheim Investigational Site
Giannitsá
1160.247.3216 Boehringer Ingelheim Investigational Site
Glyfada, Athens
1160.247.3215 Boehringer Ingelheim Investigational Site
Hrakleion ,Crete
1160.247.3201 Boehringer Ingelheim Investigational Site
Ierapetra, Crete
1160.247.3400 Boehringer Ingelheim Investigational Site
Ioannina
1160.247.3408 Boehringer Ingelheim Investigational Site
Ioannina
1160.247.3409 Boehringer Ingelheim Investigational Site
Ioannina
1160.247.3402 Boehringer Ingelheim Investigational Site
Kalamata
1160.247.3407 Boehringer Ingelheim Investigational Site
Karditsa
1160.247.3318 Boehringer Ingelheim Investigational Site
Katerini
1160.247.3312 Boehringer Ingelheim Investigational Site
Kavala
1160.247.3320 V.Pavlou 21 , Komotini
Komotini
1160.247.3415 Boehringer Ingelheim Investigational Site
Larissa
1160.247.3412 Boehringer Ingelheim Investigational Site
Pátrai
1160.247.3416 Boehringer Ingelheim Investigational Site
Pátrai
1160.247.3317 Boehringer Ingelheim Investigational Site
Serres
1160.247.3300 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3301 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3303 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3304 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3305 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3308 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3309 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3313 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3314 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3319 Boehringer Ingelheim Investigational Site
Thessaloniki
1160.247.3406 Boehringer Ingelheim Investigational Site
Trikala
1160.247.3403 Boehringer Ingelheim Investigational Site
Tripoli
1160.247.3310 Boehringer Ingelheim Investigational Site
Véroia
1160.247.3401 Boehringer Ingelheim Investigational Site
Volos
1160.247.3405 Boehringer Ingelheim Investigational Site
Xánthi
1160.247.3413 Boehringer Ingelheim Investigational Site
Xilokastro

Other trials in Greece

Belgium19 sites

1160.247.1019 Boehringer Ingelheim Investigational Site
Braine-l'Alleud
1160.247.1001 Boehringer Ingelheim Investigational Site
Brussels
1160.247.1018 Boehringer Ingelheim Investigational Site
Brussels
1160.247.1020 Boehringer Ingelheim Investigational Site
Brussels
1160.247.1013 Boehringer Ingelheim Investigational Site
De Pinte
1160.247.1010 Boehringer Ingelheim Investigational Site
Dendermonde
1160.247.1011 Boehringer Ingelheim Investigational Site
Diest
1160.247.1014 Boehringer Ingelheim Investigational Site
Edegem
1160.247.1007 Boehringer Ingelheim Investigational Site
Leuven
1160.247.1021 Boehringer Ingelheim Investigational Site
Lier
1160.247.1002 Boehringer Ingelheim Investigational Site
Maaseik
1160.247.1015 Boehringer Ingelheim Investigational Site
Meise
1160.247.1008 Boehringer Ingelheim Investigational Site
Mol
1160.247.1016 Boehringer Ingelheim Investigational Site
Mol
1160.247.1005 Boehringer Ingelheim Investigational Site
Mons
1160.247.1009 Boehringer Ingelheim Investigational Site
Nijlen
1160.247.1003 Boehringer Ingelheim Investigational Site
Ottignies-Louvain-la-Neuve
1160.247.1012 Boehringer Ingelheim Investigational Site
Roeselare
1160.247.1017 Boehringer Ingelheim Investigational Site
Tienen

Other trials in Belgium

Sweden18 sites

1160.247.7016 Boehringer Ingelheim Investigational Site
Bandhagen
1160.247.7013 Boehringer Ingelheim Investigational Site
Broby
1160.247.7006 Boehringer Ingelheim Investigational Site
Gothenburg
1160.247.7007 Boehringer Ingelheim Investigational Site
Gothenburg
1160.247.7014 Boehringer Ingelheim Investigational Site
Gothenburg
1160.247.7011 Boehringer Ingelheim Investigational Site
Hässleholm
1160.247.7019 Boehringer Ingelheim Investigational Site
Kristianstad
1160.247.7005 Boehringer Ingelheim Investigational Site
Malmö
1160.247.7001 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7002 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7003 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7004 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7008 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7010 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7012 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7017 Boehringer Ingelheim Investigational Site
Stockholm
1160.247.7009 Boehringer Ingelheim Investigational Site
Värnamo
1160.247.7015 Boehringer Ingelheim Investigational Site
Västerås

Other trials in Sweden

Netherlands13 sites

1160.247.4004 Boehringer Ingelheim Investigational Site
Amsterdam
1160.247.4010 Boehringer Ingelheim Investigational Site
Beugen
1160.247.4013 Boehringer Ingelheim Investigational Site
Capelle aan den IJssel
1160.247.4006 Boehringer Ingelheim Investigational Site
Ede
1160.247.4009 Boehringer Ingelheim Investigational Site
Goes
1160.247.4001 Boehringer Ingelheim Investigational Site
Groningen
1160.247.4008 Boehringer Ingelheim Investigational Site
Heerenveen
1160.247.4012 Boehringer Ingelheim Investigational Site
Heerlen
1160.247.4005 Boehringer Ingelheim Investigational Site
Nijmegen
1160.247.4011 Boehringer Ingelheim Investigational Site
Schiedam
1160.247.4002 Boehringer Ingelheim Investigational Site
The Hague
1160.247.4007 Boehringer Ingelheim Investigational Site
Uden
1160.247.4003 Boehringer Ingelheim Investigational Site
Veldhoven

Other trials in Netherlands

Portugal10 sites

1160.247.6003 Boehringer Ingelheim Investigational Site
Amadora
1160.247.6012 Boehringer Ingelheim Investigational Site
Angra do Heroísmo
1160.247.6007 Boehringer Ingelheim Investigational Site
Aveiro
1160.247.6004 Boehringer Ingelheim Investigational Site
Braga
1160.247.6006 Boehringer Ingelheim Investigational Site
Guimarães
1160.247.6013 Boehringer Ingelheim Investigational Site
Horta
1160.247.6002 Boehringer Ingelheim Investigational Site
Matosinhos Municipality
1160.247.6009 Boehringer Ingelheim Investigational Site
Penafiel
1160.247.6008 Boehringer Ingelheim Investigational Site
Viana do Castelo
1160.247.6005 Boehringer Ingelheim Investigational Site
Vila Franca de Xira

Other trials in Portugal

Denmark8 sites

1160.247.2006 Boehringer Ingelheim Investigational Site
Frederikssund
1160.247.2008 Boehringer Ingelheim Investigational Site
Herning
1160.247.2001 Sygehus Vendsyssel
Hjørring
1160.247.2007 Hvidovre Hospital
Hvidovre
1160.247.2003 Boehringer Ingelheim Investigational Site
Næstved
1160.247.2005 Boehringer Ingelheim Investigational Site
Nykøbing Falster
1160.247.2009 Boehringer Ingelheim Investigational Site
Roskilde
1160.247.2004 Boehringer Ingelheim Investigational Site
Svendborg

Other trials in Denmark

Norway8 sites

1160.247.5001 Boehringer Ingelheim Investigational Site
Bergen
1160.247.5007 Boehringer Ingelheim Investigational Site
Førde
1160.247.5008 Boehringer Ingelheim Investigational Site
Lierskogen
1160.247.5009 Boehringer Ingelheim Investigational Site
Nesbru
1160.247.5004 Boehringer Ingelheim Investigational Site
Oslo
1160.247.5005 Boehringer Ingelheim Investigational Site
Oslo
1160.247.5010 Boehringer Ingelheim Investigational Site
Stavanger
1160.247.5006 Boehringer Ingelheim Investigational Site
Svelvik

Other trials in Norway

About this 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

Conditions: Atrial Fibrillation
Medical subject headings: Atrial Fibrillation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02597920
Study group	Role	What they receive
Switch patients / A		Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
New AF patients / B		Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Measured: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Measured: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Patient Characterization at Baseline - Categorical Parameters
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Measured: Baseline
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Measured: Baseline
Patient Characterization at Baseline - Creatinine Clearance
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Measured: Baseline
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.
Measured: Baseline

Secondary outcomes (2)

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Measured: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
The PACT-Q1 is composed of a single dimension (7 items), covering the expectations of patients regarding their anticoagulant treatment, and was to be administered before treatment initiation. The 7 items are: A1: How confident are you that your anticoagulant treatment will prevent blood clots? A2: Do you expect that your anticoagulant treatment will relieve some of the symptoms you experience? A3: Do you expect that your anticoagulant treatment will cause side effects such as minor bruises or bleeding? A4: How important is it for you to have an anticoagulant treatment that is easy to take? A5: How concerned are you about making mistakes when taking your anticoagulant treatment? A6: How important is it for you to take care of your anticoagulant treatment by yourself? A7: How concerned are you about how much you pay for your anticoagulant treatment? Responses ranged from 1 (Not at all) to 5 (Extremely/ Completely/ Very much).
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Nov 201530 Jan 2017

First posted5 Nov 2015 (estimated)
Study start11 Nov 2015
Primary completion30 Jan 2017
Study completion30 Jan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Atrial FibrillationStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,852 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02597920
Sponsor's protocol ID: 1160.247
Status last verified: Oct 2018
First submitted: 4 Nov 2015
Last updated: 21 Feb 2019
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02597920
Acronym / sponsor ID: 1160.247
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 1,852 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: 11 Nov 2015 (actual)
Primary completion: 30 Jan 2017 (actual)
Study completion: 30 Jan 2017 (actual)
First posted: 5 Nov 2015 (estimated)
Results: Posted 21 Feb 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
Switch patients / A	–	–Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
New AF patients / B	–	–Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: European patients with non valvular atrial fibrillation

Key inclusion criteria (10 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment
Time frame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q is a self-administered questionnaire which was developed as a means to investigate patients´ satisfaction with anticoagulant treatment and treatment convenience in patients with deep venous thrombosis (DVT), pulmonary embolism (PE) or atrial fibrillation (AF). The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score (CDS). Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score (SDS). High scores are more favorable. The two dimension scores are presented for Baseline, Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD).
Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups
Time frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
The PACT-Q2 is composed of three dimensions covering: convenience (11 items), burden of disease and treatment (2 items), and anticoagulant treatment satisfaction (7 items). The PACT-Q2 was to be administered to patients once treatment was ongoing. Items for convenience and for burden of disease and treatment were reversed (reversed score = 6 - item score), added together and rescaled on a 0-100 scale to obtain the convenience dimension score. Items for anticoagulant treatment satisfaction are summed and rescaled on a 0-100 scale to determine the satisfaction dimension score. High scores are more favorable. The two dimension scores are presented for Visit 2 (second assessment) and Visit 3 (last assessment) as mean and standard deviation (SD). Propensity score matching method is used to identify matched Pradaxa® and VKA patients. Only the matched patients in each treatment group are summarized and used for comparison.
Patient Characterization at Baseline - Categorical Parameters
Time frame: Baseline
Categorical parameters of the patient characteristics at baseline included age, gender, Stroke- and/or bleeding related risk factors in medical history and at baseline (MH), co-morbidities (CoMo), concomitant therapies (CM) and dosing of Pradaxa® (DoP).
Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score
Time frame: Baseline
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ Transient Ischaemic Attack (TIA), Vascular disease, Age 65-74, Sex category. HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile INR, Elderly (>65 years), Drugs and Alcohol. CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome. HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome. CHA2DS2-VASc stroke risk score and HAS-BLED bleeding risk score at baseline are patient characteristics.
Patient Characterization at Baseline - Creatinine Clearance
Time frame: Baseline
Creatinine clearance at baseline is a measure of the patient's kidney function and is one of the baseline patient characteristics.
Patient Characteristics at Baseline - Vitamin K Antagonist Treatment Duration
Time frame: Baseline
Vitamin K Antagonist (VKA) treatment duration at baseline is only applicable for Cohort A patients and is one of the baseline patient characteristics.

2 secondary outcomes

Mean PACT-Q2 Scores, for Patients in Cohort A, at Last Assessment Compared to Second Assessment
Time frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).
Description of PACT-Q1 Items for Patients in Cohort B at Baseline
Time frame: Baseline

Results and safety

Results posted to the registry on 21 Feb 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort A Pradaxa®	585	544
Cohort B Pradaxa®	1,159	1,075
Cohort B VKA	78	72

Primary outcome: Mean Perception of Anticoagulant Treatment Questionnaire 2 (PACT-Q2) Scores, for Patients in Cohort A, at Second and Last Assessment Compared to Baseline Assessment

Time frame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).. Mean (Standard Deviation). Unit: Units on Scale

Measure	Cohort A Pradaxa® n = 585
CDS-Baseline	63.4 (25.2)
CDS-Visit 2	77.3 (19.4)
CDS-Visit 3	79.2 (17.9)
SDS-Baseline	53.8 (16.8)
SDS-Visit 2	67.7 (13.9)
SDS-Visit 3	70.0 (13.0)

Cohort A Pradaxa®: p <0.0001, Paired t-test
Cohort A Pradaxa®: p <0.0001, Paired t-test
Cohort A Pradaxa®: p <0.0001, Paired t-test

Population analysed: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible. PACT-Q2 score obtained after discontinuation of treatment or using incorrect procedure was excluded from the summary for that particular visit.

Primary outcome: Mean PACT-Q2 Scores, for Patients in Cohort B, at Second and Last Assessment Compared Between Treatment Groups

Time frame: Visit 2 (7-124 days after initiation on Pradaxa® or VKA) and Visit 3 (125-365 days after initiation on Pradaxa® or VKA).. Mean (Standard Deviation). Unit: Units on Scale

Measure	Cohort B Pradaxa® n = 1159	Cohort B VKA n = 78
CDS-Visit 2	78.3 (13.4)	69.1 (22.6)
CDS-Visit 3	80.3 (10.5)	69.5 (22.3)
SDS-Visit 2	65.9 (7.8)	58.0 (13.3)
SDS-Visit 3	68.4 (8.8)	58.8 (15.9)

Cohort B Pradaxa® vs Cohort B VKA: p = 0.0005, Propensity score matching method
Cohort B Pradaxa® vs Cohort B VKA: p = 0.0002, Propensity score matching method
Cohort B Pradaxa® vs Cohort B VKA: p = 0.0002, Propensity score matching method

Primary outcome: Patient Characterization at Baseline - Categorical Parameters

Time frame: Baseline. Number. Unit: Percentage of participants

Measure	Cohort A Pradaxa® n = 585	Cohort B Pradaxa® n = 1159	Cohort B VKA n = 78
Age: < 65 years	14.2	17.9	12.8
Age: ≥ 65 and < 75 years	36.4	36.6	28.2
Age: ≥ 75 years	49.4	45.6	59.0
Gender: Male	55.9	55.1	44.9
Gender: Female	44.1	44.9	55.1
MH: Thromboembolism	14.0	9.1	12.8
MH: Cardiovascular Conditions	22.4	18.5	21.8
MH: Bleedings	4.1	2.5	7.7

Population analysed: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

Primary outcome: Patient Characteristics at Baseline - CHA2DS2-VASc Stroke Risk Score and HAS-BLED Bleeding Risk Score

Time frame: Baseline. Mean (Standard Deviation). Unit: Units on scale

Measure	Cohort A Pradaxa® n = 585	Cohort B Pradaxa® n = 1159	Cohort B VKA n = 78
CHA2DS2-VASc	3.4 (1.5)	3.2 (1.4)	3.8 (1.3)
HAS-BLED	2.1 (0.9)	1.7 (0.8)	2.0 (1.0)

Population analysed: Eligible patients: All patients who took the prescribed treatment and without specific important protocol violations are eligible.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From signing the informed consent till end of the study; up to 290 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort A Pradaxa®	4 of 585 (0.7%)	0 of 585 (0%)	1 of 585
Cohort B Pradaxa®	8 of 1,159 (0.7%)	0 of 1,159 (0%)	5 of 1,159
Cohort B VKA	2 of 78 (2.6%)	0 of 78 (0%)	1 of 78

Limitations and caveats (from the sponsor): This study was conducted in an unblinded manner so site and patient selection bias could have occurred. Therefore, current practice patterns at these sites may not necessarily reflect patterns of care elsewhere.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Synopsis LinkLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

148 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 148 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 148 sites in Greece, Belgium, Sweden, Netherlands, Portugal and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Baseline, Visit 2 (7-124 days after initiation on Pradaxa® or VKA), Visit 3 (125-365 days after initiation on Pradaxa® or VKA).). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02597920.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2019.