Active not recruitingOBSERVATIONAL

High Gastrointestinal Bleed Risk Outcomes in Patients With Non-valvular Atrial Fibrillation (NVAF) in France

This study is reviewing existing health information from patients in France. It's focused on people with an irregular heart rhythm called atrial fibrillation who are taking blood-thinning medications but also have a higher chance of stomach or gut bleeding. Researchers are looking at different types of blood thinners, including older ones (like warfarin, also known as Vitamin K antagonists) and newer ones (like Apixaban, Rivaroxaban, and Dabigatran). The main goal is to understand how these medications have been used, and to compare their safety and how well they worked in real-world situations for this specific group of patients. This kind of study helps us learn more about the effects of these important medicines without directly involving patients in new drug trials.

At a glance

Status

Active not recruiting

Sponsor

Pfizer

Enrolment target

Start

01 Aug 2022

Estimated completion

29 May 2026

Atrial Fibrillation

What is this study about?

This research project is like looking back through patient records to understand more about specific blood-thinning medicines. Researchers in France are examining information from people who have a common heart condition called atrial fibrillation, which causes an irregular and often very fast heartbeat. People with this condition often need to take blood thinners to help prevent serious problems like strokes.

However, some people taking blood thinners are also at a higher risk of bleeding in their stomach or gut. This study specifically focuses on these individuals. The researchers are comparing how two main types of blood thinners — older ones like warfarin (often called Vitamin K antagonists) and newer ones (Apixaban, Rivaroxaban, and Dabigatran, known as DOACs) — have been used in day-to-day healthcare. They want to see how effective and safe these different medications have been in real patients.

By analysing existing data, the study helps to build a clearer picture of treatment patterns and outcomes for people facing the dual challenge of atrial fibrillation and a higher risk of internal bleeding. This kind of research is valuable because it uses information from many patients in real-life situations, which can offer important insights into how different treatments work outside of controlled clinical trials.

Key takeaways

This study looks at existing health records, not new patients.
It focuses on people with an irregular heartbeat (atrial fibrillation) who take blood thinners.
A key interest is patients who also have a higher risk of stomach bleeding.
Researchers are comparing older and newer blood-thinning medications.
The goal is to learn more about the real-world safety and effectiveness of these treatments.
This research does not involve giving new medicines or patient participation.

Who may be eligible?

This study is looking at information from adults aged 18 or over in France who are part of the national health insurance system. These individuals must have had a diagnosis of atrial fibrillation (an irregular heartbeat) and have been prescribed certain blood-thinning medications, including Apixaban, Rivaroxaban, Dabigatran, or older types of blood thinners such as Vitamin K antagonists.

Importantly, they must also have had at least one factor that puts them at higher risk of bleeding in their stomach or gut. This helps the researchers focus on the specific group of patients they are interested in.

However, the study excludes patients who were taking different types of blood thinners at the very start of the observation period. Also excluded are those with specific heart valve problems (like rheumatic mitral valve disease or a replaced heart valve) or those who had been diagnosed with specific types of blood clots (venous thromboembolism) in the year leading up to a key point in their health record.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult aged 18 or over?
Do you have a diagnosis of an irregular heartbeat (atrial fibrillation)?
Have you been prescribed certain blood-thinning medications (like Apixaban, Rivaroxaban, Dabigatran, or warfarin)?
Do you have a known risk factor for bleeding in your stomach or gut?
Do you NOT have specific heart valve problems or replaced heart valves?
Have you NOT been diagnosed with certain types of blood clots in the last year?

Answer every question to see your result.

What does participation involve?

This study doesn't involve you directly or ask you to do anything. It's a 'retrospective' study, meaning researchers are looking back at existing, anonymised French health records that have already been collected as part of routine care. They are not giving out new medication or asking people to attend appointments. Your personal information will not be identifiable to the researchers. You don't need to sign up or agree to anything, as the study is using previously collected, de-identified data.

Potential risks and benefits

Since this study only involves analysing existing, anonymised patient records, there are no direct risks or benefits to individual patients. No new treatments are being given, and no personal information will be shared or identified. The potential benefit of this type of research is to help doctors and patients understand more about the safety and effectiveness of different blood-thinning medications for people with atrial fibrillation who also have a higher risk of stomach bleeding. This knowledge could help improve future treatment decisions. As no individuals are participating, there is no right to withdraw personal data, as the data used is de-identified and analysed in aggregate.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Pfizer Investigator
Verified postcode
London, United Kingdom

Common questions

What is 'atrial fibrillation'?

Atrial fibrillation is a common heart condition that causes an irregular and often abnormally fast heart rate. It can increase the risk of stroke.

What are blood thinners and why are they used?

Blood thinners (anticoagulants) are medicines that help prevent blood clots. For people with atrial fibrillation, they are used to reduce the risk of strokes caused by blood clots forming in the heart.

What does 'high risk of gastrointestinal bleed' mean?

This means a person has a higher chance of bleeding in their stomach or intestines, which can sometimes be a side effect of blood-thinning medications.

Is this study giving out new medicines?

No, this study is not giving out any new medicines. It's looking at information about medicines that patients have already been prescribed as part of their routine care in the past.

How does this study affect me?

This study does not directly affect you as an individual. It uses anonymous health data to learn more about treatments, which could indirectly help improve care for patients like you in the future.