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
1 other identifier
observational
164
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2020
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 21, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
February 10, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedNovember 5, 2021
October 1, 2021
10 months
November 21, 2019
October 28, 2021
Conditions
Outcome Measures
Primary Outcomes (10)
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
Study Arms (2)
Patients
Non-valvular atrial fibrillation (NVAF) patients who will start treatment with a non-VKA oral anticoagulants (NOAC).
Physicians
Treating physicians for NVAF patients.
Interventions
The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
Eligibility Criteria
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.
You may qualify if:
- Male or female adult patients diagnosed with NVAF.
- NOAC treatment-naive patients who will start a NOAC treatment.
You may not qualify if:
- Previous stroke or thrombosis
- Previous severe bleeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (1)
Many locations
Multiple Locations, Belgium
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2019
First Posted
December 3, 2019
Study Start
February 10, 2020
Primary Completion
November 30, 2020
Study Completion
December 31, 2020
Last Updated
November 5, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
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.