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European Multinational Prolongation Registry on Prevention of Thromboembolic Events in Atrial Fibrillation

Organizational Data

DRKS-ID:
DRKS00005996
Recruitment Status:
Recruiting complete, study continuing
Date of registration in DRKS:
2014-05-22
Last update in DRKS:
2016-05-06
Registration type:
Prospective

Acronym/abbreviation of the study

Prolongation PREFER in AF Registry

URL of the study

No Entry

Brief summary in lay language

This study is a prolongation of the already completed register study for the prevention of thromboembolic events in atrial fibrillation. Aim of the oberservation is to collect data of patients with atrial fibrillation (the most common cardiac arrhythmia) concerning their medical history, their concomitant diseases and their treatment with a focus on the prevention of thromoembolic events (i.e. formation of a clot in a blood vessel (thrombus) that breaks lose and is carried by the blood stream to plug another vessel in the lungs (pulmonary embolism), brain (stroke), gastrointestinal tract, kidneys, or leg).

Brief summary in scientific language

Prolongation of the currently ongoing Multinational Registry on Prevention of Thromboembolic Events in Atrial Fibrillation (PREFER in AF) to gain further insight into the long-term management of patients with AF, with special focus on the use of new oral anticoagulants (NOACs). In the PREFER in AF registry a large patient population is observed and data on different anticoagulation treatment patterns are collected. The aim of this registry is to prolong the patient observation period and recruit new patients to gain further insights into the long-term use of NOACs, including switching from Vitamin K antagonists (VKAs), to NOACs in a real life setting. This will include the collection of data on direct healthcare resource use and estimated costs correlated in patients with AF.

Health condition or problem studied

ICD10:
I48 - Atrial fibrillation and flutter
Free text:
MedDRA - 10003658 Atrial fibrillation
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
- only patients treated with NOAC or VKA; - Description of charakteristics of AF patients in terms of key (socio-)demographic data, risk factors, method of diagnosis, treatment modalities; - Retrospective documentation of events related to AF and anticoagulation therapy (within a 1 year period prior to inclusion); - Assessment of quality of life at baseline (visit1); - Prospective observation of patients with atrial fibrillation; - Prospective collection of outcome data; - Prospective assessment of quality of life at 1 year; - Assessment of selected complications related to (oral) anticoagulants prescribed in AF, in particular bleeding; - Information on treatment itensity, frequencies and resource use for pharmaco-economic analyses.

Endpoints

Primary outcome:
To describe the long-term use of NOACs and corresponding prescription patterns, including reasons for switching from VKAs to NOACs.
Secondary outcome:
To gain insight on the long-term management of patients with atrial fibrillation (AF), treated with either NOACs or VKAs, with focus on the prevention of thromboembolic events. To assess selected complications related to oral anticoagulants prescribed in AF, in particular bleeding. To explore the relationship between anticoagulants and duration of therapy, adherence to therapy, resource utilization, estimated costs, treatment satisfaction, and health related quality of life, and clinical outcomes. All the above mentioned objectives will be measured one year after baseline visit via a EQ-5D-5L and PACT-Q2. Also diaries will be distributed to the patients to record their contact with physician, nurse or other facilities throughout the year.

Study Design

Purpose:
Prevention
Retrospective/prospective:
No Entry
Study type:
Non-interventional
Longitudinal/cross-sectional:
No Entry
Study type non-interventional:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study continuing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Austria
  • Belgium
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom
Number of study centers:
Multicenter study
Recruitment location(s):
  • Doctor's practice Gotha
  • Doctor's practice Dachau
  • University medical center Isar Herzzentrum München - Klinik für Kardiologie u. Internist. Intensivmedizin München
  • Doctor's practice Lohne
  • Doctor's practice Helmstedt
  • Medical center Klinikum Lippe Detmold Detmold
  • Medical center Universitätsklinikum Carl Gustav Carus der TU Dresden Dresden
  • Doctor's practice Riesa

Recruitment period and number of participants

Planned study start date:
2014-06-09
Actual study start date:
2014-06-25
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
5000
Final Sample Size:
4171

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
-At least 18 years of age; -Written informed consent for participation in the registry; -History of non-valvular AF documented by electrical tracing (ECG, holter, pacemaker, implantable cardioverter defibrillator) within the prior 12 months; -Treated with NOAC or VKA;

Exclusion Criteria

Patients with mechanical valve replacements or moderate, moderately severe or severe mitral stenosis are not allowed to be enrolled.

Addresses

Primary Sponsor

Daiichi Sankyo Europe GmbH
Zielstattstr. 48
81379 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
No

Contact for Scientific Queries

Daiichi Sankyo Europe GmbH, Clinical Operations
Dr. Petra Laeis
Zielstattstr. 48
81379 München
Germany
Telephone:
+49 (0)89 7808-614
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Daiichi-Sankyo Europe GmbH, Clinical Operations
Dr. Petra Laeis
Zielstattstr. 48
81379 München
Germany
Telephone:
+49 (0) 89 7808 614
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Daiichi Sankyo Europe GmbH, Clinical Operations
Dr. Petra Laeis
Zielstattstr. 48
81379 München
Germany
Telephone:
+49 (0)89 7808-614
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Commercial (pharmaceutical industry, medical engineering industry, etc.)

Daiichi Sankyo Europe GmbH, Zielstattstr. 48
81379 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Bayerischen Landesärztekammer
Mühlbaurstr. 16
81677 München
Germany
Telephone:
+49-89-4147165
Fax:
+49-89-4147334
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-03-25
Ethics committee number:
14026
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-05-09

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
Other secondary IDs:
DSE-EAF-01-13 - sponsor-id
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No Entry
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry