check_circleStudy Completed
atrial fibrillation
Bayer Identifier:
21153
ClinicalTrials.gov Identifier:
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.
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
AllAge
18 - N/ATrial summary
Enrollment Goal
164Trial Dates
February 2020 - December 2020Phase
Phase 4Could I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many locations | Many locations, Belgium |
Primary Outcome
- Age categories of patientsCollected via the questionnaire.date_rangeTime Frame:1 day
- Gender (Female or male) of patientsCollected via the questionnaire.date_rangeTime Frame:1 day
- Patients' level of agreement with various statements of using NOACs in generalBy 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 - 10date_rangeTime Frame:1 day
- Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10date_rangeTime Frame:1 day
- Age categories of physiciansCollected via the questionnaire.date_rangeTime Frame:1 day
- Gender (Female or male) of physiciansCollected via the questionnaire.date_rangeTime Frame:1 day
- Physicans' level of agreement with various statement of using NOACs in generalBy 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 - 10date_rangeTime Frame:1 day
- Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10date_rangeTime Frame:1 day
Trial design
Trial Type
ObservationalIntervention Type
OtherTrial Purpose
OtherAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A