check_circleStudy Completed

atrial fibrillation

Bayer Identifier:

21153

ClinicalTrials.gov Identifier:

NCT04183270

EudraCT Number:

Not Available

EU CT Number:

Not Available
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.

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A
  • 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

Trial summary

Enrollment Goal
164
Trial Dates
February 2020 - December 2020
Phase
Phase 4
Could I Receive a placebo
No
Products
Unspecified
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Belgium

Primary Outcome

  • Age categories of patients
    Collected via the questionnaire.
    date_rangeTime Frame:
    1 day
  • Gender (Female or male) of patients
    Collected via the questionnaire.
    date_rangeTime Frame:
    1 day
  • 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)
    date_rangeTime Frame:
    1 day
  • Level of patients fear of having a bleeding on a scale from 0 - 10
    date_rangeTime Frame:
    1 day
  • Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10
    date_rangeTime Frame:
    1 day
  • Age categories of physicians
    Collected via the questionnaire.
    date_rangeTime Frame:
    1 day
  • Gender (Female or male) of physicians
    Collected via the questionnaire.
    date_rangeTime Frame:
    1 day
  • 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)
    date_rangeTime Frame:
    1 day
  • Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10
    date_rangeTime Frame:
    1 day
  • Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10
    date_rangeTime Frame:
    1 day

Trial design

BELgian ANtiCOagulation Survey for NVAF patients
Trial Type
Observational
Intervention Type
Other
Trial Purpose
Other
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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