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. (BELANCOS)

BELgian ANtiCOagulation Survey for NVAF Patients

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Questionnaires

• Study Type: Observational
• Enrollment (Actual): 164

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Non-valvular atrial fibrillation (NVAF) patients who will start treatment with a non-VKA oral anticoagulants (NOAC).	Other: Questionnaires; The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
Physicians; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 28, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 21153

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No