PRESTIGE-AF Qualitative sub-study
Research type
Research Study
Full title
PREvention of STroke in Intracerebral haemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF): Qualitative sub-study
IRAS ID
250522
Contact name
Deirdre A Lane
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
2018-002176-41, EudraCT Number
Duration of Study in the UK
2 years, 0 months, 30 days
Research summary
Research Summary:
In the main trial we are examining what is the best strategy to prevent a stroke caused by a clot (an ischaemic stroke) in patients who have a common heart rhythm abnormality called atrial fibrillation (AF) and who have recently had a bleed in their brain called an 'intracerebral haemorrhage'. Having AF makes you more likely to suffer an ischaemic stroke as it can cause blood clots to form in the
heart, which can travel up to the brain and block off one of the blood vessels.The standard treatment to reduce the risk of stroke in patients with AF is an anti-clotting drug called an “anticoagulant” to help prevent blood clots forming. However, a side effect of anticoagulants is that they can make patients more likely to bleed. It is not currently known whether patients who have had a bleed in their brain (intracerebral haemorrhage) should take an anticoagulant to reduce their risk of stroke or not. This main study will test this.Half of the participants in the trial will take an anticoagulant medication and half will not. This qualitative sub-study will examine these patients attitudes towards taking medication to reduce their risk of stroke. As these patients have all experienced a major bleed in their brain they may be reluctant to take a medication that could increase their risk of further bleeding. Doctors who treat these patients are often faced with a dilemma over the best course of treatment. They have to weigh up the risk/benefit of an anti-clot medication (bleeding in the brain versus stroke caused by a blood clot) and this qualitative study will also explore the decision-making process of the doctors who treat patients with AF who have survived a bleed in their brain.
Summary of Results:
Background: Atrial fibrillation is a common irregular heart rhythm that increases the risk of stroke caused by a blood clot (ischaemic stroke). Oral anticoagulation medication can be used to lower the risk of stroke. However, this type of medication can increase the risk of serious bleeding, such as bleeding in the brain. For people with atrial fibrillation who also have a bleed on the brain (intracerebral haemorrhage), it can be difficult to decide if the benefits of oral anticoagulants are greater than the risk of maybe having another serious bleed.
The study reported here is a sub-study of the PREvention of STroke in Intracerebral HemorrhaGE survivors with Atrial Fibrillation (PRESTIGE-AF) trial (NCT03996772).
The aims of the sub-study were to (1) explore how doctors decide if a patient who has atrial fibrillation and a bleed on the brain should be offered an oral anticoagulant or not; and (2) explore how patients who have atrial fibrillation and a bleed on the brain decide if they should take oral anticoagulant medication or not. This study used interviews with doctors and patients to collect this information.
Results: Twenty doctors from five different European countries and 12 patients from across England took part in this study. The main theme that described how doctors make their decision was called ‘Managing uncertainty’. This showed that doctors are not always sure if patients who have atrial fibrillation and a bleed on the brain should be prescribed oral anticoagulants or not. There were three smaller themes, called ‘Computing the risks’ (meaning how the results of tests and scans influenced doctors' decision), ‘Patient Factors’ (meaning how the doctor considered what the patient would or would not like to do), and ‘Making a decision’ (meaning how the doctor and patient tried to agree on a decision together). The main theme that described how patients make their decision was called ‘Living my life as normal’. This showed that patients were mostly worried about having a good quality of life after their brain bleed. There were three broad areas that affected how patients thought about the benefits and risks of taking an oral anticoagulant after a brain bleed to prevent a further stroke, which were: individual (meaning how the person themselves felt about the medication), medical (meaning the advice that the person received from doctors), and social (meaning how the person’s family and friends influenced their decision).
Impact of the findings: This was the first study of its kind, using interviews, to explore how doctors and patients decide if a person who has atrial fibrillation and a bleed on the brain should take oral anticoagulant medication to lower the risk of ischaemic stroke (stroke caused by a blood clot). The findings show that each patient may have their own views on what the right treatment is, and that doctors and other health professionals need to work together with the patient and their family to find a treatment that is best suited to that person. The study also showed that patients who want to tell doctors about their worries and preferences should be supported to do so.
Lay Summary of results
Atrial fibrillation, the most common irregular heart rhythm, increases the risk of stroke caused by a blood clot (ischaemic stroke). Oral anticoagulation medication can be used to lower the risk of stroke. However, this type of medication can increase the risk of serious bleeding, such as bleeding in the brain. For people with atrial fibrillation who also have a bleed on the brain (intracerebral haemorrhage), it can be difficult to decide if the benefits of oral anticoagulants are greater than the risk of maybe having another serious bleed.
The study reported here is a sub-study of the Prevention of Stroke in Intracerebral Haemorrhage survivors with Atrial Fibrillation (PRESTIGE-AF) trial (NCT03996772).
The aims of the sub-study were to (1) explore how doctors decide if a patient who has atrial fibrillation and a bleed on the brain should be offered an oral anticoagulant or not; and (2) explore how patients who have atrial fibrillation and a bleed on the brain decide whether or not to take oral anticoagulant medication. This study used interviews with doctors and patients to collect this information.
Results: Twenty doctors from five different European countries and 12 patients from across England took part in this study. The main theme that described how doctors make their decision was called ‘Managing uncertainty’. This showed that doctors are not always sure if patients who have atrial fibrillation and a bleed on the brain should be prescribed oral anticoagulants or not. There were three sub-themes, called ‘Computing the risks’ (meaning how the results of tests and scans influenced doctors' decision), ‘Patient Factors’ (meaning how the doctor considered what the patient would or would not like to do), and ‘Making a decision’ (meaning how the doctor and patient tried to agree on a decision together). The main theme that described how patients make their decision was called ‘Living my life as normal’. This showed that patients were mostly worried about having a good quality of life after their brain bleed. There were three broad areas that affected how patients thought about the benefits and risks of taking an oral anticoagulant after a brain bleed to prevent a further stroke, which were: individual (meaning how the person themselves felt about the medication), medical (meaning the advice that the person received from doctors), and social (meaning how the person’s family and friends influenced their decision).
Impact of the findings: This was the first study of its kind, using interviews, to explore how doctors and patients decide if a person who has atrial fibrillation and a bleed on the brain should take oral anticoagulant medication to lower the risk of ischaemic stroke (stroke caused by a blood clot). The findings show that each patient may have their own views on what the right treatment is, and that doctors and other healthcare professionals need to work together with the patient and their family to find a treatment that is best suited to that person. The study also showed that patients who want to tell doctors about their worries and preferences should be supported to do so.REC name
South Central - Oxford A Research Ethics Committee
REC reference
19/SC/0435
Date of REC Opinion
26 Sep 2019
REC opinion
Further Information Favourable Opinion