An observational study in Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-11-05.
Sponsored by Bayer · Observational
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.
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 164 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.
Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.
Counted across the registry records on this site, refreshed daily.
The source population of this study would be approximately 15 cardiologists (hospital or office-based) and 300 NOAC treatment-naïve patients diagnosed with NVAF who will start treatment with a NOAC for this indication.
Exclusion criteria:
Non-valvular atrial fibrillation (NVAF) patients who will start treatment with a non-VKA oral anticoagulants (NOAC).
Other: Questionnaires
Treating physicians for NVAF patients.
Other: Questionnaires
The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
Age categories of patients
Collected via the questionnaire.
Time frame: 1 day
Gender (Female or male) of patients
Collected via the questionnaire.
Time 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)
Time frame: 1 day
Level of patients fear of having a bleeding on a scale from 0 - 10
Time frame: 1 day
Level of patients fear of having a stroke or thrombosis on a scale from 0 - 10
Time frame: 1 day
Age categories of physicians
Collected via the questionnaire.
Time frame: 1 day
Gender (Female or male) of physicians
Collected via the questionnaire.
Time 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)
Time frame: 1 day
Level of patients fear of having a bleeding assessed by physicans on a scale from 0 - 10
Time frame: 1 day
Level of patients fear of having a stroke or thrombosis assessed by physicians on a scale from 0 - 10
Time frame: 1 day
Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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