RecruitingPHASE4INTERVENTIONAL

Preventing Stroke, Premature Death and Cognitive Decline in a Broader Community of Patients With Atrial Fibrillation

This NHS study, called DaRe2THINK, is exploring if a type of medication called Direct Oral Anticoagulants (DOACs) can prevent serious problems like strokes and memory decline in people aged 55 to 73 years with an irregular heartbeat condition known as atrial fibrillation. These are people who might be considered at a lower or medium risk of stroke. The study uses a clever new way to find patients, enroll them, and follow their health by using existing NHS records. This means there are no extra hospital visits for participants. The aim is to understand if DOACs are effective and offer good value for money for this group, and to show how this new research method can help future studies.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

University of Birmingham

Enrolment target

3,000

Start

01 Jun 2021

Estimated completion

01 Jan 2031

Atrial Fibrillation

What is this study about?

Imagine your heart has a very fast, irregular beat – that's atrial fibrillation, or AF. It's a common condition, and for some people, it can increase the risk of a stroke or other serious health issues, including problems with memory and thinking. This research study, called DaRe2THINK, wants to understand if a type of medication known as Direct Oral Anticoagulants (DOACs), which are blood thinners, can help prevent these serious problems in a specific group of people with AF.

Currently, DOACs are often given to older individuals with AF who are at a higher risk of stroke. This study is focusing on people aged between 55 and 73 who have AF but are considered to be at a lower or medium risk of stroke. The researchers want to see if giving DOACs to these younger patients can effectively lower their chances of having a stroke, developing other harmful blood clots, and even help protect their memory and thinking skills over time.

What's special about DaRe2THINK is how it's being run. It's using new technology to go through NHS health records across England to identify suitable patients. There are no extra hospital or clinic visits needed for those taking part. This makes it really easy for patients and aims to show how research can be done more efficiently within the NHS. This study could help many people with AF by finding out the best ways to keep them healthy and prevent serious health problems in the future.

Key takeaways

The study investigates if blood thinners (DOACs) can help prevent strokes and memory decline in people aged 55-73 with atrial fibrillation.
It uses existing NHS health records, so no extra appointments or visits are needed.
Participants will be randomly chosen to either take DOACs or receive usual care.
The study aims to improve understanding of how to treat AF and prevent serious health problems.
Potential benefits include reduced risk of stroke; potential risks include increased bleeding.
You can stop participating at any time.

Who may be eligible?

This study is looking for people who have an irregular heartbeat condition called atrial fibrillation (AF). You would need to be between 55 and 73 years old to be considered.

There are also some important reasons why you might not be able to join. For example, if you've already had a stroke or a mini-stroke (TIA), or if you already take blood-thinning medication. You also wouldn't be able to participate if you have certain other serious health conditions, especially those that increase your risk of bleeding or if you have severe kidney problems. If you have been diagnosed with dementia, or are currently in another clinical trial, you wouldn't be able to join this one.

Before taking part, doctors will also check your health records for specific conditions. You also wouldn't be able to join if you are a woman who could become pregnant. The research team will carefully check all these details with your GP to make sure it's safe for you to be part of the study.

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.

Do I have atrial fibrillation?
Am I between 55 and 73 years old?
Have I ever had a stroke or mini-stroke (TIA)? (If yes, you may not be eligible)
Do I currently take blood-thinning medication? (If yes, you may not be eligible)
Do I have a serious bleeding condition or severe kidney problems? (If yes, you may not be eligible)
Am I currently taking part in another medical research study? (If yes, you may not be eligible)

Answer every question to see your result.

What does participation involve?

If you are invited to join the DaRe2THINK study, it's designed to be as simple as possible. You won't need to attend any extra appointments or clinic visits. The study works by using your existing NHS health records, both from your GP and from hospitals, to monitor your health over time.

If you agree to take part, you would provide your permission online to allow the researchers to access your health records for the study. You would then be randomly chosen to either start taking Direct Oral Anticoagulants (DOACs) – which are blood-thinning medicines – or continue with your usual care, meaning you wouldn’t take any study medication. Your GP will be kept updated throughout the process.

The study will initially run for five years, but researchers plan to check in on certain results, like your memory and thinking, again after ten years. If you are given DOACs, there will be careful monitoring of your health and any side effects, particularly relating to bleeding, through your health records. You will not have any extra appointments specifically for the study.

Potential risks and benefits

Taking part in this study could offer several potential benefits. It might help us understand if a commonly used medicine can prevent strokes, serious blood clots, and memory problems in a wider group of people with atrial fibrillation, potentially improving care for future patients. If you are assigned to take the study medication, you might personally benefit from a reduced risk of these events. However, like all medicines, DOACs carry potential risks, the main one being an increased risk of bleeding, which can sometimes be serious. The study will carefully monitor blood records. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

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

University Hospitals Birmingham
Verified postcode
Birmingham, United Kingdom· Recruiting

Common questions

What is atrial fibrillation?

Atrial fibrillation (AF) is a heart condition where your heart beats irregularly and often very fast. It can increase your risk of stroke.

What are DOACs?

DOACs (Direct Oral Anticoagulants) are types of medicine that thin your blood. They help prevent harmful blood clots from forming, which can cause strokes.

Will I have to go to extra appointments?

No, this study is designed so you won't need any extra visits. Your health will be monitored using your existing NHS medical records.

How long does the study last?

The main part of the study will last for five years, but researchers will look at some outcomes, like memory, again after ten years.

What if I change my mind about taking part?

You can withdraw from the study at any time without any reason, and it won't affect your medical care.

How to find out more

Alastair Mobley, BSc

a.mobley@bham.ac.uk +44 121 371 4225 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.