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Completed

NCT Number: NCT04183270

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.

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.

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Key information

Conditions

Atrial Fibrillation Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

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

Primary outcomes

  1. Age categories of patients

    Time frame: 1 day

    Collected via the questionnaire.

  2. Gender (Female or male) of patients

    Time frame: 1 day

    Collected via the questionnaire.

  3. Patients' level of agreement with various statements of using NOACs in general

    Time frame: 1 day

    By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)

  4. Level of patients fear of having a bleeding on a scale from 0 - 10

    Time frame: 1 day

  5. Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10

    Time frame: 1 day

  6. Age categories of physicians

    Time frame: 1 day

    Collected via the questionnaire.

  7. Gender (Female or male) of physicians

    Time frame: 1 day

    Collected via the questionnaire.

  8. Physicans' level of agreement with various statement of using NOACs in general

    Time frame: 1 day

    By using a 5-point Likert scale (completely disagree, more likely to disagree, no opinion, more likely to agree, completely agree)

  9. Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10

    Time frame: 1 day

  10. Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

BELgian ANtiCOagulation Survey for NVAF Patients

Acronym: BELANCOS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2019
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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