Survey on Belgian Patients Suffering From Irregular Heartbeat and Starting Treatment With a Drug to Prevent Blood Clots in Blood Vessels and the Heart. This Study is Also Called BELANCOS.

Atrial Fibrillation Clinical Trial

— BELANCOS  

Official title:

BELgian ANtiCOagulation Survey for NVAF Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04183270
• Other study ID #: 21153
• Status: Completed
• Start date: February 10, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2021
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study researchers want to learn more about the patient's and treating doctor's concerns about possible bleedings during treatment with drugs preventing blood clots in blood vessels and the heart - so called blood thinner. The study also wants to find out more about the patient's knowledge on the importance, risks and benefits of treatment with this drug group.

Patients with irregular heartbeat not caused by valvular heart disease who will start treatment with a blood thinner will be asked by their treating cardiologist to complete a questionnaire related to their knowledge and fear of possible bleedings or stroke (blockage or rupture of a blood vessel to the brain) due to the intake of a blood thinner. The treating doctor will complete a similar questionnaire. The study plans to involve 15 cardiologists and 300 patients in Belgium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 31, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• Male or female adult patients diagnosed with NVAF.

• NOAC treatment-naive patients who will start a NOAC treatment.

Exclusion criteria:

• Previous stroke or thrombosis

• Previous severe bleeding

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Other:
• Questionnaires
The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.

Locations

Country	Name	City	State
Belgium	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age categories of patients	Collected via the questionnaire.	1 day
Primary	Gender (Female or male) of patients	Collected via the questionnaire.	1 day
Primary	Patients' level of agreement with various statements of using NOACs in general	By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)	1 day
Primary	Level of patients fear of having a bleeding on a scale from 0 - 10		1 day
Primary	Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10		1 day
Primary	Age categories of physicians	Collected via the questionnaire.	1 day
Primary	Gender (Female or male) of physicians	Collected via the questionnaire.	1 day
Primary	Physicans' level of agreement with various statement of using NOACs in general	By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)	1 day
Primary	Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10		1 day
Primary	Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10		1 day

External Links

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