- IRAS ID: 1009448
- ISRCTN: 13146458
Why is this research being done?
You are scheduled to have, or have had, surgery to repair a valve in your heart, called the mitral valve.
This mitral valve repair surgery is to fix leakiness around the valve that has been allowing blood to flow the wrong way (called mitral regurgitation).
This may have been causing you to feel unwell, for example you might have been feeling breathless or dizzy.
After mitral valve repair surgery, there are risks of certain complications, such as blood clots and stroke.
These risks are greater for people who also have an irregular heartbeat (called atrial fibrillation).
To try and prevent such complications, the current national and international guidelines recommend that patients are given a blood-thinning medication called a vitamin K antagonist (VKA).
In the UK this is usually warfarin, though very occasionally other VKAs called acenocoumarol are used.
Using a VKA (such as warfarin) is very effective at preventing strokes but may be inconvenient as it requires blood tests to make sure the right dose is taken.
However, some people prefer to have the blood tests to be reassured that they are taking the right dose and being monitored.
There is another type of blood thinner called a Direct Oral Anti-Coagulant (DOAC) which is a newer type of drug than VKAs.
They do not require blood tests and because of this advantage, some doctors have started to prescribe these after surgery. However, no research has been done to test if they are better, worse, or the same as VKAs (warfarin).
We know that both VKAs (warfarin) and DOACs can reduce the risk of having a stroke, but they can also increase the chances of bleeding and bruising.
What happens to me if I agree to take part in this research?
If you agree to take part in this research study and your clinical team confirm that you are eligible you will be randomly allocated to one of two groups by a computer (like tossing a coin).
One group will receive the guideline-recommended therapy of VKAs (such as warfarin) and one group will receive DOACs.
There is equal chance of being allocated to each group and you will be prescribed the medicine to take at that point, before you leave hospital.
You should continue to take the same medicine for as long as you are taking part in the trial, which could be for up to four years.
Once you leave hospital we will monitor your health for between 1 and 4 years. During this time, you will be contacted over the phone at three months, 12 months and then yearly and asked about your health and to complete questionnaires.
If you provide an e-mail address then you will be contacted every three months between visits, directly from the trial database to complete a simple online questionnaire.
How many people will take part in this research?
1,282
Where is this study taking place?
We aim to deliver this study across about 25 cardiac centres throughout the UK.
Current study centres are:
- The James Cook University Hospital, Middlesbrough, South Tees Hospitals NHS Foundation Trust
- Royal Sussex County Hospital, University Hospitals Sussex NHS Foundation Trust
- Glenfield Hospital, Leicester, University Hospitals of Leicester NHS Trust
- Castle Hill Hospital, Hull University Teaching Hospitals NHS Trust
- St. George’s London, St. George’s University Hospitals NHS Foundation Trust
- Derriford Hospital, University Hospitals Plymouth NHS Trust
- Liverpool Heart and Chest Hospital, Liverpool Heart and Chest Hospital NHS Foundation Trust
- Victoria Hospital Blackpool, Blackpool Teaching Hospitals NHS Foundation Trust
- Royal Brompton Hospital, Guy’s and St. Thomas’ NHS Foundation Trust
- King’s College Hospital, King’s College Hospital NHS Foundation Trust
- St. Bart’s London, Bart’s Health NHS Trust
- Harefield Hospital, Guy’s and St. Thomas’ NHS Foundation Trust
- Royal Infirmary of Edinburgh, NHS Lothian
- St. Thomas’ Hospital, Guy’s and St. Thomas’ NHS Foundation Trust
- Southampton General Hospital, University Hospital Southampton NHS foundation Trust
- Nottingham City Hospital, Nottingham University Hospitals NHS Trust
- Bristol Heart Institute, University Hospitals Bristol and Weston NHS Foundation Trust
- Freeman, The Newcastle-upon-Tyne Hospitals NHS Foundation Trust
- Northern General Hospital, Sheffield Teaching Hospitals NHS Foundation Trust
- Queen Elizabeth Hospital Birmingham, University Hospitals Birmingham NHS Foundation Trust
- Royal Papworth Hospital, Royal Papworth Hospital NHS Foundation Trust
- Basildon Hospital, Mid and South Essex NHS Foundation Trust
- Golden Jubilee Hospital, NHS Golden Jubilee, Glasgow
- Hammersmith Hospital, Imperial College Healthcare NHS Trust
- Morriston Hospital, Swansea Bay University Health Board
- University Hospital of Wales, Cardiff an Vale University Health Board
Can I take part in this study?
We are looking for people over the age of 18 who have confirmed persistent or permanent atrial fibrillation (irregular heartbeat) who are planned to undergo a surgical repair of one of their heart valves (the mitral valve).
There are additional criteria you would need to fulfil to be able to participate, so please speak to your usual care team about this.
How do I take part in this study?
In the first instance, speak to your usual care team or contact your closest hospital.
They will be able to provide you with more detailed information and discuss with you what participation involves.
You are also able to email the central study team via [email protected]
Who is organising and funding the study?
National Institute for Health and Care Research (NIHR), Health Technology Assessment (HTA) Programme grant funding is awarded to support the delivery of this trial.
NIHR Grant Number: NIHR160252
The Academic Cardiovascular Unit at South Tees Hospitals NHS Foundation Trust is organising this study.
South Tees Hospitals NHS Foundation Trust is the ‘sponsor’ of this study, meaning they are legally responsible.
The study has been submitted for favourable ethical opinion (ethical approval) by London – Harrow Research Ethics Committee.
Trial research team
Chief investigator
Professor Enoch Akowuah, consultant cardiothoracic surgeon, The James Cook University Hospital, Middlesbrough.
ACU team
- Ms Louise Steel, senior research manager
- Dr Lisa Chang, principal research manager
- Ms Olivia Sawdon, research coordinator
Wider research team
- Rebecca Maier, head of the Academic Cardiovascular Unit at South Tees Hospitals NHS Foundation Trust.
- Mr Bilal Kirmani, consultant cardiothoracic surgeon, Liverpool Heart and Chest Hospital.
- Professor James Wason, professor of biostatistics, University of Newcastle upon Tyne.
- Professor Laura Ternent, professor of health economics, University of Newcastle upon Tyne.
- Ms Helen Mossop, senior research associate in statistics, University of Newcastle upon Tyne.
- Professor Laura Green, professor of haemostasis and transfusion medicine; consultant in haemostasis and transfusion medicine, Queen Mary University of London.
- Professor Gregory Lip, Price-Evans chair of cardiovascular medicine, director of Liverpool centre for cardiovascular science, University of Liverpool.
- Professor Julie Sanders, professor of cardiovascular care, King’s College London.
- Professor Scott Wilkes, head of the School of Medicine, professor of general practice and primary care, University of Sunderland.
- Mrs Sarah Murray, BHF CRC National PPI Group chair, patient and public involvement and engagement representative.
- Professor Gavin Murphy, professor of cardiac surgery and consultant cardiac surgeon, University of Leicester.
- Mr Narain Moorjani, consultant cardiothoracic surgeon, Royal Papworth Hospital.
- Dr Benoy Shah, consultant cardiologist, University Hospitals Southampton.
Current study status
- Recruitment opened April 2025.
- Planned study end date Friday 31 May 2030.