Patient Perceptions and Physician Assessment of Benefits and Risks of Oral Anticoagulation Due to Non-valvular AF
1 other identifier
observational
91
1 country
8
Brief Summary
The risk of stroke is markedly elevated in patients with atrial fibrillation (AF). Oral anticoagulation (OAC) is indicated in individuals with moderate and high risk of stroke to the disadvantage of an increased burden from bleeding. Adequate knowledge of this disorder and understanding the benefits and hazards of antithrombotic treatment are essential to incorporate patient´s values and preferences in these decisions. This will further improve acceptance of recommended therapy and augment compliance with OAC. The objective of this investigation is to compare patient´s perceptions and physician´s assessments of benefits and risks of OAC.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2015
Typical duration for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedSeptember 15, 2023
September 1, 2023
2.1 years
February 17, 2017
September 14, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison of subjective stroke risk perception with CHA2DS2-VASc score
Baseline
Comparison of subjective bleeding risk perception with HAS-BLED score
Baseline
Secondary Outcomes (1)
Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information)
Baseline
Interventions
Eligibility Criteria
Patients with atrial fibrillation with new indication for anticoagulation.
You may qualify if:
- Diagnosed and ECG-documented non-valvular atrial fibrillation
- New indication for oral anticoagulation (OAC)
- Ability of informed consent
You may not qualify if:
- Existing OAC therapy
- Valvular heart disease
- History of valve surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
LKH Feldbach
Feldbach, 8330, Austria
LKH Fürstenfeld
Fürstenfeld, 8280, Austria
Hospital Barmherzige Brueder Eggenberg
Graz, 8020, Austria
Hospital Barmherzige Brueder Marschallgasse
Graz, 8020, Austria
Hospital Elisabethinen
Graz, 8020, Austria
Medical University of Graz
Graz, 8036, Austria
LKH Hartberg
Hartberg, 8230, Austria
Ordination Dr. Zweiker
Straden, 8345, Austria
Related Publications (1)
Zweiker D, Zweiker R, Winkler E, Roesch K, Schumacher M, Stepan V, Krippl P, Bauer N, Heine M, Reicht G, Zweiker G, Sprenger M, Watzinger N. Association between subjective risk perception and objective risk estimation in patients with atrial fibrillation: a cross-sectional study. BMJ Open. 2017 Sep 25;7(9):e018242. doi: 10.1136/bmjopen-2017-018242.
PMID: 28951417DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
September 1, 2015
Primary Completion
October 1, 2017
Study Completion
October 1, 2017
Last Updated
September 15, 2023
Record last verified: 2023-09