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

An observational study of Atrial Fibrillation, run by Boehringer Ingelheim at 161 sites in 8 countries.

Completed

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

Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Atrial Fibrillation
How many people: 1,213 participants
Where: 161 sitesin 8 countries
Study dates: Jan 2015to Aug 2015
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: Physicians prescribing dabigatran for patients with atrial fibrillation

Who may be able to join

Pradaxa® prescribers (cardiologists and primary care physicians)
Patients with atrial fibrillation treated with Pradaxa®

Who cannot join

As defined in Summary of Product Characteristics for patients treated with Pradaxa®

Trial locations and contacts

161 sites in 8 countries.

Country

City, postcode or hospital

161 sites in 8 countries

France45 sites

Boehringer Ingelheim Investigational Site 25
Ambleuteuse
Boehringer Ingelheim Investigational Site 68
Ardres
Boehringer Ingelheim Investigational Site 26
Arnac-Pompadour
Boehringer Ingelheim Investigational Site 27
Audincourt
Boehringer Ingelheim Investigational Site 28
Bart
Boehringer Ingelheim Investigational Site 29
Besançon
Boehringer Ingelheim Investigational Site 30
Buissière Galant
Boehringer Ingelheim Investigational Site 32
Châlus
Boehringer Ingelheim Investigational Site 31
Charbrignac
Boehringer Ingelheim Investigational Site 33
Coussac-Bonneval
Boehringer Ingelheim Investigational Site 34
Décines-Charpieu
Boehringer Ingelheim Investigational Site 35
Eckwersheim
Boehringer Ingelheim Investigational Site 36
Geneuille
Boehringer Ingelheim Investigational Site 37
Glandon
Boehringer Ingelheim Investigational Site 65
Gruson
Boehringer Ingelheim Investigational Site 38
Halluin
Boehringer Ingelheim Investigational Site 39
Lanouaille
Boehringer Ingelheim Investigational Site 67
Le Catelet
Boehringer Ingelheim Investigational Site 40
Le Haillan
Boehringer Ingelheim Investigational Site 41
Lille
Boehringer Ingelheim Investigational Site 42
Limoges
Boehringer Ingelheim Investigational Site 43
Lomme
Boehringer Ingelheim Investigational Site 44
Lyon
Boehringer Ingelheim Investigational Site 45
Marseille
Boehringer Ingelheim Investigational Site 46
Mérignac
Boehringer Ingelheim Investigational Site 47
Nexon
Boehringer Ingelheim Investigational Site 48
Noaillan
Boehringer Ingelheim Investigational Site 24
Paris
Boehringer Ingelheim Investigational Site 52
Saint Saud Lacousserie
Boehringer Ingelheim Investigational Site 55
Saint-Hilaire-les-Places
Boehringer Ingelheim Investigational Site 50
Saint-Martial-d'Albarède
Boehringer Ingelheim Investigational Site 51
Saint-Martin-Sepert
Boehringer Ingelheim Investigational Site 53
Saint-Sornin-Lavolps
Boehringer Ingelheim Investigational Site 54
Saint-Yrieix-la-Perche
Boehringer Ingelheim Investigational Site 56
Schiltigheim
Boehringer Ingelheim Investigational Site 57
Sochaux
Boehringer Ingelheim Investigational Site 58
Strasbourg
Boehringer Ingelheim Investigational Site 59
Talence
Boehringer Ingelheim Investigational Site 60
Thiviers
Boehringer Ingelheim Investigational Site 66
Tourcoing
Boehringer Ingelheim Investigational Site 61
Tourmignies
Boehringer Ingelheim Investigational Site 49
Val Pompadour
Boehringer Ingelheim Investigational Site 62
Villenave-d'Ornon
Boehringer Ingelheim Investigational Site 63
Voujeaucourt
Boehringer Ingelheim Investigational Site 64
Weyersheim

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Slovakia44 sites

Boehringer Ingelheim Investigational Site 122
Banská Bystrica
Boehringer Ingelheim Investigational Site 127
Bardejov
Boehringer Ingelheim Investigational Site 152
Bratislava
Boehringer Ingelheim Investigational Site 146
Čierna nad Tisou
Boehringer Ingelheim Investigational Site 149
Čierne Kľačany
Boehringer Ingelheim Investigational Site 154
Čierny Brod
Boehringer Ingelheim Investigational Site 139
Dolné Kočkovce
Boehringer Ingelheim Investigational Site 141
Horný Vadičov
Boehringer Ingelheim Investigational Site 137
Ivanka pri Dunaji
Boehringer Ingelheim Investigational Site 140
Jelka
Boehringer Ingelheim Investigational Site 159
Kokava nad Rimavicou
Boehringer Ingelheim Investigational Site 125
Košice
Boehringer Ingelheim Investigational Site 158
Košťany nad Turcom
Boehringer Ingelheim Investigational Site 160
Krásno nad Kysucou
Boehringer Ingelheim Investigational Site 134
Lalinok
Boehringer Ingelheim Investigational Site 120
Lastovce
Boehringer Ingelheim Investigational Site 155
Liptovský Hrádok
Boehringer Ingelheim Investigational Site 145
Lučenec
Boehringer Ingelheim Investigational Site 144
Nitra
Boehringer Ingelheim Investigational Site 119
Nové Mesto nad Váhom
Boehringer Ingelheim Investigational Site 150
Nové Zámky
Boehringer Ingelheim Investigational Site 124
Odorín
Boehringer Ingelheim Investigational Site 142
Oščadnica
Boehringer Ingelheim Investigational Site 157
Poprad
Boehringer Ingelheim Investigational Site 128
Považská Bystrica
Boehringer Ingelheim Investigational Site 132
Považský Chlmec
Boehringer Ingelheim Investigational Site 118
Prešov
Boehringer Ingelheim Investigational Site 138
Púchov
Boehringer Ingelheim Investigational Site 143
Radoľa
Boehringer Ingelheim Investigational Site 153
Rešov
Boehringer Ingelheim Investigational Site 156
Revúca
Boehringer Ingelheim Investigational Site 147
Rožkovany
Boehringer Ingelheim Investigational Site 131
Rudinka
Boehringer Ingelheim Investigational Site 126
Sabinov
Boehringer Ingelheim Investigational Site 161
Skalité
Boehringer Ingelheim Investigational Site 123
Spišská Nová Ves
Boehringer Ingelheim Investigational Site 130
Stráňavy
Boehringer Ingelheim Investigational Site 121
Trebišov
Boehringer Ingelheim Investigational Site 151
Trnava
Boehringer Ingelheim Investigational Site 129
Trnové
Boehringer Ingelheim Investigational Site 135
Valasska Bela
Boehringer Ingelheim Investigational Site 148
Vráble
Boehringer Ingelheim Investigational Site 133
Žilina
Boehringer Ingelheim Investigational Site 136
Zvolen

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Czechia29 sites

Boehringer Ingelheim Investigational Site 92
?eská Lípa
Boehringer Ingelheim Investigational Site 93
?eské Bud?jovice
Boehringer Ingelheim Investigational Site 94
?eský Krumlov
Boehringer Ingelheim Investigational Site 90
B?eclav
Boehringer Ingelheim Investigational Site 89
Benesov U Prahy
Boehringer Ingelheim Investigational Site 91
Brno
Boehringer Ingelheim Investigational Site 95
Chomutov
Boehringer Ingelheim Investigational Site 96
Domažlice
Boehringer Ingelheim Investigational Site 97
Haví?ov
Boehringer Ingelheim Investigational Site 98
Havlí?k?v Brod
Boehringer Ingelheim Investigational Site 99
Ho?ovice
Boehringer Ingelheim Investigational Site 100
Hradec Králové
Boehringer Ingelheim Investigational Site 101
Ivan?ice
Boehringer Ingelheim Investigational Site 102
Krom??íz
Boehringer Ingelheim Investigational Site 103
Kyjov
Boehringer Ingelheim Investigational Site 104
Liberec
Boehringer Ingelheim Investigational Site 105
Louny
Boehringer Ingelheim Investigational Site 106
Most
Boehringer Ingelheim Investigational Site 107
Nový Bor
Boehringer Ingelheim Investigational Site 108
Odry
Boehringer Ingelheim Investigational Site 109
Olomouc
Boehringer Ingelheim Investigational Site 110
Pardubice
Boehringer Ingelheim Investigational Site 111
Plze?
Boehringer Ingelheim Investigational Site 112
Prague
Boehringer Ingelheim Investigational Site 113
Sternberk
Boehringer Ingelheim Investigational Site 114
Tábor
Boehringer Ingelheim Investigational Site 115
Tehovec
Boehringer Ingelheim Investigational Site 116
Teplice
Boehringer Ingelheim Investigational Site 117
Valasské Mezi?í?í

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Germany14 sites

Boehringer Ingelheim Investigational Site 9
Berlin
Boehringer Ingelheim Investigational Site 3
Bremen
Boehringer Ingelheim Investigational Site 10
Chemnitz
Boehringer Ingelheim Investigational Site 5
Düsseldorf
Boehringer Ingelheim Investigational Site 6
Essen
Boehringer Ingelheim Investigational Site 1
Frankfurt
Boehringer Ingelheim Investigational Site 8
Hanover
Boehringer Ingelheim Investigational Site 14
Heidelberg
Boehringer Ingelheim Investigational Site 11
Leipzig
Boehringer Ingelheim Investigational Site 2
Mannheim
Boehringer Ingelheim Investigational Site 7
Marburg
Boehringer Ingelheim Investigational Site 13
München
Boehringer Ingelheim Investigational Site 4
Nuremberg
Boehringer Ingelheim Investigational Site 12
Rostock

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Bulgaria10 sites

Boehringer Ingelheim Investigational Site 81
Dobrich
Boehringer Ingelheim Investigational Site 84
Gabrovo
Boehringer Ingelheim Investigational Site 79
Montana
Boehringer Ingelheim Investigational Site 85
Plovdiv
Boehringer Ingelheim Investigational Site 80
Shumen
Boehringer Ingelheim Investigational Site 86
Sliven
Boehringer Ingelheim Investigational Site 87
Sofia
Boehringer Ingelheim Investigational Site 88
Stara Zagora
Boehringer Ingelheim Investigational Site 82
Varna
Boehringer Ingelheim Investigational Site 83
Veliko Tarnovo

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Spain9 sites

Boehringer Ingelheim Investigational Site 23
Baleares
Boehringer Ingelheim Investigational Site 22
Barcelona
Boehringer Ingelheim Investigational Site 15
Ciudad Real
Boehringer Ingelheim Investigational Site 16
Galicia
Boehringer Ingelheim Investigational Site 17
Madrid
Boehringer Ingelheim Investigational Site 18
Murcia
Boehringer Ingelheim Investigational Site 19
Seville
Boehringer Ingelheim Investigational Site 20
Valencia
Boehringer Ingelheim Investigational Site 21
Zaragoza

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United Kingdom9 sites

Boehringer Ingelheim Investigational Site 71
Brighton
Boehringer Ingelheim Investigational Site 76
Cheadle
Boehringer Ingelheim Investigational Site 78
Essex
Boehringer Ingelheim Investigational Site 70
London
Boehringer Ingelheim Investigational Site 77
Manchester
Boehringer Ingelheim Investigational Site 74
Middlesex
Boehringer Ingelheim Investigational Site 73
Romford
Boehringer Ingelheim Investigational Site 75
Stockport
Boehringer Ingelheim Investigational Site 72
Surrey

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Denmark1 site

Boehringer Ingelheim Investigational Site 69
Copenhagen

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About this study

Official title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF

Read the detailed description

Purpose:

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 NCT02433366
Study group	Role	What they receive
Patients		Not described
Physicians		Not described

What is being measured

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

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

Timeline

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

Jan 2015Aug 2015

First posted5 May 2015 (estimated)
Study startJan 2015
Primary completionAug 2015
Study completionAug 2015

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: Cross-sectional
Enrolment: 1,213 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02433366
Sponsor's protocol ID: 1160.149
Status last verified: Jul 2016
First submitted: 25 Mar 2015
Last updated: 19 Sep 2016
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?

See locations

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

All Atrial Fibrillation trials

Study at a glance

From the registry record, last updated by the sponsor on 19 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Post-authorisation Study to Evaluate the Effectiveness of the Risk Minimisation Activities in the Treatment of SPAF
ClinicalTrials.gov ID: NCT02433366
Acronym / sponsor ID: 1160.149
Conditions: Atrial Fibrillation
Study type: Observational
Recruitment status: Completed
Enrolment: 1,213 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2015
Primary completion: Aug 2015 (actual)
Study completion: Aug 2015 (actual)
First posted: 5 May 2015 (estimated)
Results: Posted 19 Sep 2016

Clinical summary

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

Detailed description

Purpose:

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
Patients	–	–
Physicians	–	–

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Physicians prescribing dabigatran for patients with atrial fibrillation

Key inclusion criteria (2 listed)

Pradaxa® prescribers (cardiologists and primary care physicians)
Patients with atrial fibrillation treated with Pradaxa®

Key exclusion criteria (1 listed)

As defined in Summary of Product Characteristics for patients treated with Pradaxa®

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

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.
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.

Results and safety

Results posted to the registry on 19 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Physicians	411	411
Patients	802	802

Primary outcome: 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. Number. Unit: Percentage of Participants

Measure	Physicians n = 411	Patients n = 0
A	65	–
B	71	–
C	95	–
D	100	–

Population analysed: Physicians who were current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF)

Primary outcome: 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. Number. Unit: Percentage of Participants

Measure	Physicians n = 0	Patients n = 802
A	–	55
B	–	83
C	–	100
D	–	89
E	–	54
F	–	52

Population analysed: AF patients on treatment with Pradaxa®.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Physicians	0 of 0	0 of 0	Not reported
Patients	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Atrial Fibrillation

Active, not recruiting
Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Sphere-360™ Catheter and Affera™ Mapping and Ablation System (Horizon 360)
Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
Active, not recruiting
CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)

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

161 sites in 8 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 161 sites in 8 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 2 inclusion and 1 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 19 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 161 sites in France, Slovakia, Czechia, Germany, Bulgaria and 3 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 19 Sep 2016). 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?

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 study lists 2 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 NCT02433366.

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 19 Sep 2016.