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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03061123
Other study ID # 28-004 ex 15/16
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2015
Est. completion date October 2017

Study information

Verified date September 2023
Source Medical University of Graz
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date October 2017
Est. primary completion date October 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility Inclusion Criteria: - Diagnosed and ECG-documented non-valvular atrial fibrillation - New indication for oral anticoagulation (OAC) - Ability of informed consent Exclusion Criteria: - Existing OAC therapy - Valvular heart disease - History of valve surgery

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Questionnaire


Locations

Country Name City State
Austria LKH Feldbach Feldbach
Austria LKH Fürstenfeld Furstenfeld
Austria Hospital Barmherzige Brueder Eggenberg Graz
Austria Hospital Barmherzige Brueder Marschallgasse Graz
Austria Hospital Elisabethinen Graz
Austria Medical University of Graz Graz
Austria LKH Hartberg Hartberg
Austria Ordination Dr. Zweiker Straden

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary Comparison of subjective stroke risk perception with CHA2DS2-VASc score Baseline
Primary Comparison of subjective bleeding risk perception with HAS-BLED score Baseline
Secondary Relationship between accurate perception of stroke and bleeding risks and baseline parameters (highest completed level of education, subjective level of information) Baseline
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