A study of direct oral anticoagulants for patients with a first stroke
Research type
Research Study
Full title
A descriptive non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke attributable to nonvalvular atrial fibrillation
IRAS ID
253458
Contact name
James Uprichard
Contact email
Sponsor organisation
Daiichi Sankyo UK
Clinicaltrials.gov Identifier
NA, NA
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
This is a United Kingdom (UK), multi-centre, mixed methodology, non-interventional study.
This study will be conducted in 5 National Health Service centres in the UK. The study is based on both retrospective secondary use of hospital and/or primary care data from medical records (primary care data requested from the patients’ General Practitioner [GP] or family doctor) and also prospective data collection from medical records (paper-based and/or electronic, as appropriate). The study will also involve prospectively collected patient-reported data using questionnaires.
The population for this study is adult patients who have had a first ischaemic stroke (an ‘ischaemic stroke’ is a type of stroke that happens when a blood vessel supplying the brain becomes blocked by a blood clot). The study will include patients who have had a first ischaemic stroke caused by a condition called ‘nonvalvular Atrial fibrillation (AF)’, which is a type of irregular heart rhythm. The study is expected to recruit 300 patients in total.
Data will be collected retrospectively from medical records of all patients in the study (Group 1) for the 12 month period before the date of diagnosis of a first ischaemic stroke. For a subgroup of these patients (Group 2) who receive a particular type of blood thinning medication known as a ‘direct oral anticoagulant’ (DOAC), prospective data will also be collected from medical records and patients will be asked to complete questionnaires at 3 and 6 months after the first DOAC dose (and at the time of the first dose of DOAC treatment, where applicable).
Summary of study results:
1. Study identification
Short title: A study of direct oral anticoagulants for patients with a first stroke
Full title: A descriptive non-interventional study to evaluate the use of direct oral anticoagulants in UK clinical practice for patients with a first stroke attributable to non-valvular atrial fibrillation
IRAS Project ID: 253458
Research Ethics Committee reference: 18/LO/1923
2. Who sponsored the study and how can I contact them?
The sponsor of this study was Daiichi Sankyo. This means they were responsible for setting up and running the study. They also provided the money to fund it. Daiichi Sankyo can be contacted via their website https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.daiichisankyo.com%252Fcontact%252F.%2FNBTI%2FKkq5AQ%2FAQ%2F71801c64-cede-4036-83be-adf0fb5da3ac%2F2%2Fk6djBFuCXp&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7Cee6392d1960e4a7e86cc08dd02595137%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638669304813281025%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=fQXAKMclwh3ToUmQzaKNCtFX%2FojmHFsfZyFJR9vxQeE%3D&reserved=0 Daiichi Sankyo would like to thank everyone who took part.
3. General information about the researchThis research study started in January 2020 and finished in March 2023 (when the study report was completed). Recruitment was paused between April 2020 and June 2020 due to the COVID pandemic. Eight hospitals across the UK took part.
The study was carried out to gain a better understanding of how blood thinning medications (‘anticoagulants’), and in particular, a group of medicines called direct oral anticoagulants (DOACs), are used to treat people for stroke prevention.
The main purpose of the research was to find out which patients receive anticoagulants for the prevention of a second stroke after a first stroke caused by non-valvular atrial fibrillation (a heart rhythm problem) in routine practice. For patients who received DOACs, we also wanted to see:
• How these DOACs are used, including changes in dose and reasons for stopping treatment
• How many times patients attended hospital in the 6 months after starting DOACs
• The extent to which patients took their DOAC as prescribed
• How satisfied patients were with their DOAC treatmentPeople aged over 18 years who presented to one of the participating hospitals with a first stroke caused by non-valvular atrial fibrillation could take part in the study. The study was split into two groups. Group 1 included all recruited patients with a first stroke caused by non-valvular atrial fibrillation. Group 2 included a subgroup of patients from Group 1 who were prescribed one of three specific direct FXa inhibitor DOACs (apixaban, edoxaban, or rivaroxaban) to prevent another stroke.
This study was an ‘observational research study’, which means that we looked at what happened to patients as part of their routine care. The patients did not have to do anything different because they were taking part in the study. The only extra thing that we asked patients to do was to complete some questionnaires.
To answer the main study question, the researchers collected information from the medical records of patients in Group 1, for 12 months before they had their first stroke and up to 1 month afterwards. To answer the remaining study questions, the researchers collected information from the medical records of patients in Group 2, for up to 6 months from the date their doctor prescribed them a DOAC. Patients in Group 2 also completed questionnaires at the time their doctor prescribed them a DOAC, and at 3 and 6 months afterwards.
The research staff at the hospital gave each patient their own study number so only people who needed to know who these patients were could see the patients’ names and contact details. Only specially trained researchers were allowed to look at the medical records so that the patients’ personal information stayed private.4. What were the results of the study?
Main outcome (Group 1):
Overall, in Group 1, 234 people took part in the study. Most of the people who took part were male (64%) and the average age was 75 years old. Most patients (70%) had a CHA2DS2-VASc risk score of 4 or more (CHA2DS2-VASc is a scale used to measure the risk of stroke in patients with atrial fibrillation based on risk factors, with higher scores equating to a higher risk of stroke). Patients were most commonly diagnosed with atrial fibrillation on the day of their stroke. Lifestyle-related risk factors for stroke in the study patients included obesity (22% of patients with a body mass index of 30 or more), being a current smoker (10%) and alcohol consumption (62%).
Secondary outcomes (Group 2):
Overall, 93 patients were prescribed a direct FXa inhibitor DOAC after their stroke and were included in Group 2. Forty-nine of the patients were prescribed apixaban, 39 edoxaban and 5 rivaroxaban. The average (median) time between having a stroke and receiving the first dose of DOAC was 6 days. Only one patient was recorded as having had a change (increase) in dose of their DOAC during the study period and almost all patients were still being treated with their first DOAC at the end of the study. None of the patients started treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) or antiplatelets (including aspirin) in the 6 months after they were prescribed a DOAC.
At 3 and 6 months, 73% and 83% of patients, respectively, reported a high level of adherence to their prescribed DOAC. No patients reported being dissatisfied with their DOAC medication at 3 or 6 months after initiation.5. How has this study helped patients and researchers?
• The results of this study showed that direct FXa inhibitor DOAC usage was largely in compliance with guidelines.
• High levels of adherence, persistence, and treatment satisfaction, and fairly low levels of hospital attendance, were seen in the 6 months after DOAC initiation.
• Most patients in the study were first diagnosed with atrial fibrillation on the day of their stroke; this suggests that there is potential for screening programs to identify atrial fibrillation prior to first stroke and initiate stroke prevention treatment with anticoagulation.
• Overall, these results will help doctors and nurses by providing valuable insights into the experience of post-stroke patients with non-valvular atrial fibrillation receiving DOAC treatment. This information may help them to manage future patients.
• Researchers look at the results of many studies to understand the use of DOACs in real-world practice. It takes lots of people in many studies around the world to advance medical science. This summary only shows the results from this one study. Further research may help validate these findings.6. Are further studies planned?
No further studies by the sponsor on the use of DOACs following first stroke attributed to non-valvular atrial fibrillation are planned at the current time in this region.
7. Where can I learn more about this study?
To learn more about this study, you can find more detailed information on this website: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fwww.hra.nhs.uk%252Fplanning-and-improving-research%252Fapplication-summaries%252Fresearch-summaries%252Fa-study-of-direct-oral-anticoagulants-for-patients-with-a-first-stroke%252F%2FNBTI%2FKkq5AQ%2FAQ%2F71801c64-cede-4036-83be-adf0fb5da3ac%2F3%2FkjOQ8iwSg8&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7Cee6392d1960e4a7e86cc08dd02595137%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638669304813304450%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=SR3Ck4oaUPxEcX8EvCDoyPSsnd%2FTo0lgqj7BLkHh3lk%3D&reserved=0
You can also find more details about this study at https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fbmcneurol.biomedcentral.com%252Farticles%252F10.1186%252Fs12883-019-1530-0%2FNBTI%2FKkq5AQ%2FAQ%2F71801c64-cede-4036-83be-adf0fb5da3ac%2F4%2F8vsOT0yYNS&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7Cee6392d1960e4a7e86cc08dd02595137%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638669304813330327%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=enf7IUy7adbWbFeEdcJg6csD8oudumyg%2FPp3GXcyEZ4%3D&reserved=0REC name
London - South East Research Ethics Committee
REC reference
18/LO/1923
Date of REC Opinion
3 Jan 2019
REC opinion
Further Information Favourable Opinion