Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice For Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation

15 июля 2022 г. обновлено: Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company

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

National Institute of Health and Care Excellence (NICE) guidance recommends anticoagulation for stroke prevention in high risk patients with nonvalvular atrial fibrillation (AF).

Early evidence suggest that patients with atrial fibrillation (AF) who do not receive anticoagulation are more likely to experience a stroke. However, the characteristics of patients experiencing a first AF-related stroke in real-world settings, who have not been receiving anticoagulation, have not been well documented.

It is unclear how the direct anti-FXa oral anticoagulants have been used within real world practice since the introduction of edoxaban in 2015.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Подробное описание

This non-interventional study will focus specifically on the patient characteristics, management pathways, and patient reported experiences associated with real world use of three direct anti-FXa oral anticoagulants (DOAC) commonly used within United Kingdom clinical practice; apixaban, rivaroxaban and edoxaban.

The primary objective will describe the demographics, clinical characteristics and medical history of patients presenting with a first ischaemic stroke with AF who have not received anticoagulation (for any reason) in the 12 months prior to stroke, by type of anticoagulant treatment subsequently prescribed for secondary prophylaxis of stroke.

Secondary objectives of the study will describe management pathways of patients initiated on DOACs (apixaban, edoxaban or rivaroxaban) for secondary prophylaxis of stroke, including timing and reasons for any dose changes or treatment switches to alternative anticoagulants; describe hospital resource use and clinical assessments associated with DOAC treatment for secondary prophylaxis of stroke; describe real world patient-reported adherence to DOACs for secondary prophylaxis of stroke; and describe patient experience and treatment satisfaction for patients receiving DOAC therapy for secondary prophylaxis of stroke.

Тип исследования

Наблюдательный

Регистрация (Действительный)

234

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

  • Соединенное Королевство
      • Glasgow, Соединенное Королевство, G51 4TF
        • Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde
      • Gloucester, Соединенное Королевство, GL1 3NN
        • Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust
      • Leicester, Соединенное Королевство, LE1 5WW
        • Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust
      • London, Соединенное Королевство, SW17 0QT
        • St George's Hospital - St George's University Hospital's NHS Foundation Trust
      • Newcastle, Соединенное Королевство, NE1 4LP
        • Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust
      • Newport, Соединенное Королевство, NP20 2UB
        • Royal Gwent Hospital - Aneurin Beban University Health Board
      • Taunton, Соединенное Королевство, TA1 5DA
        • Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust
      • Yeovil, Соединенное Королевство, BA21 4AT
        • Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

18 лет и старше (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Все

Метод выборки

Невероятностная выборка

Исследуемая популяция

For the wider retrospective study (Group 1 patients), potentially eligible participants will be identified by members of the direct care team from local department databases. Eligible participants will be selected in consecutive chronological order by the direct care team according to the date of stroke diagnosis until the required sample size or the center-specific recruitment target is reached, over a one-year recruitment period.

The first 50 eligible and consenting participants initiated on either apixaban, edoxaban or rivaroxaban at any of the study centers during the 28 month recruitment period will also be included in the prospective component of the study.

Описание

Inclusion Criteria:

- For all patients:

  • Participants presenting to the study centre with a first ischaemic stroke which is, in the clinician's opinion, attributable to nonvalvular AF
  • Participants aged 18 years or over at time of first stroke

For group 2 patients:

* Participants initiated on apixaban, edoxaban or rivaroxaban after their first stroke

Exclusion Criteria:

  • For all patients:

    • Participants prescribed any anticoagulant for any purpose in the 12 months prior to stroke diagnosis
    • Participants with haemorrhagic stroke
    • Participants with diagnosis of transient ischemic attack
    • Participants with severe cognitive or emotive deficit
    • Participants whose medical records are not available for review
    • Participant unwilling or unable to give written informed consent

  • For group 2 patients:

    • Participant unwilling or unable to complete the patient-reported questionnaires

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

Когорты и вмешательства

Группа / когорта
Вмешательство/лечение
All Participants (Group 1; Retrospective)
All participants' data will be collected retrospectively from medical records 12 months prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Subset of All Participants (Group 2; Prospective)
A subset of participants from Group 1 who were initiated on apixaban, edoxaban or rivaroxaban for secondary prophylaxis of stroke will take part in this prospective component of the study, whereby data on their management pathway (treatments and follow-up appointments) and patient-reported outcomes will be collected for 6 months from the date of first dose of DOAC treatment.
Лекарство: Edoxaban
This was a non-interventional, observational study. No drug was administered in this study.
Лекарство: Apixaban
This was a non-interventional, observational study. No drug was administered in this study.
Лекарство: Rivaroxaban
This was a non-interventional, observational study. No drug was administered in this study.

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean CHA2DS2-VASc Risk Scores In Participants Presenting With A First Stroke with Atrial Fibrillation (AF) Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Временное ограничение: 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
CHA2DS2-VASc risk scores range from 0-9, where a score of 0 is "low" risk of stroke, 1 is "moderate", and any score above 1 is a "high" risk. Scores will be calculated based on relevant demographic and clinical data recorded in medical notes for pre-index observation period.
12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Mean Time from Atrial Fibrillation (AF) Diagnosis Until Stroke In Participants Presenting With A First Stroke with Atrial Fibrillation Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Временное ограничение: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
The time from AF diagnosis until stroke will be assessed.
Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Stroke Severity In Participants Presenting With A First Stroke with Atrial Fibrillation (AF) Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Временное ограничение: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Stroke severity will be assessed by NIHSS classification (mild, moderate, moderate to severe, and severe), Oxfordshire Community Stroke Project Score, classification based on CT scan, and opinion of treating clinician.
Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Number of Participants With Relevant Cardiovascular and Related Non-Cardiovascular Conditions In Participants Presenting With A First Stroke with Atrial Fibrillation Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Временное ограничение: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Cardiovascular and related non-cardiovascular events, such as hypertension, congestive heart failure, vascular disease (peripheral artery disease, previous myocardial infarction, aortic plaque), diabetes mellitus, renal impairment, renal failure, hepatic failure, coronary artery disease, carotid artery disease, reduced ejection fraction, liver disease, and other, will be assessed.
Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Number of Participants Receiving Concomitant Medications At Time of First Stroke and Newly Prescribed Within 1 Month After Stroke
Временное ограничение: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Concomitant medications may include: beta blockers, diuretics, antiplatelet agents (e.g. aspirin), ACE (angiotensin-converting-enzyme) inhibitors, ATII-receptor antagonists, statins, ASA (acetylsalicylic acid), and P-gp (P-glycoprotein) inhibitors.
Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Type of First Anticoagulant Medication Prescribed After Stroke In Participants Presenting With A First Stroke with Atrial Fibrillation Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Временное ограничение: Within 1 month after stroke
Anticoagulant medications may include apixaban, edoxaban, rivaroxaban, warfarin, dabigatran, and other.
Within 1 month after stroke
Time From Stroke to First Dose of Direct Oral Anticoagulant (DOAC) in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: From stroke to first dose of DOAC, up to 6 months after date of first dose of DOAC
The time from stroke to first dose of anticoagulant medication will be assessed.
From stroke to first dose of DOAC, up to 6 months after date of first dose of DOAC
Time to Discontinuation of First Direct Oral Anticoagulant (DOAC) Treatment in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Up to 6 months after date of first dose of DOAC
The time to discontinuation of anticoagulant medication will be assessed.
Up to 6 months after date of first dose of DOAC
Number of Participants Receiving Clinical Assessments in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Up to 6 months after date of first dose of DOAC
Clinical assessments may include weight, coagulation screens (international normalized ratio), full blood count (FBC), urea and electrolyte tests (U&E), renal function and liver function tests (alanine transaminase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [ALP], albumin and bilirubin tests) as well as other neurological, heart or functional assessments (thyroid function tests, blood pressure, 12 lead ECG/EKG including heart rate, echocardiography and relevant imaging CT scan, ultrasound, MRI and PET scans.
Up to 6 months after date of first dose of DOAC
Number of Secondary Care Visits in 6 Months Post-first Direct Oral Anticoagulant (DOAC) Dose in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Up to 6 months after date of first dose of DOAC
Secondary visits will include inpatient, outpatient, and accident and emergency.
Up to 6 months after date of first dose of DOAC
Duration of Inpatient Stays in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Up to 6 months after date of first dose of DOAC
The length of inpatient hospital stays will be assessed.
Up to 6 months after date of first dose of DOAC
Mean Absolute Morisky Medication Adherence Scale (MMAS-8) Score After First Direct Oral Anticoagulant (DOAC) Dose in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Up to 6 months after date of first dose of DOAC
Morisky Medication Adherence Scale (MMAS-8) range from 0 to 8, where higher scores indicate medication adherence and lower scores indicate nonadherence. Medication adherence will be assessed at 3 and 6 months.
Up to 6 months after date of first dose of DOAC
Number of Participants Taking Direct Oral Anticoagulant (DOAC) Medication Within Past 7 Days in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Временное ограничение: Within past 7 days
Anticoagulant medication may include apixaban, edoxaban, rivaroxaban, warfarin, dabigatran, and other. DOAC medication will be assessed at 3 and 6 months.
Within past 7 days
Mean Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score Post-first Direct Oral Anticoagulant Dose
Временное ограничение: Up to 6 months after date of first dose of DOAC
Treatment Satisfaction Questionnaire for Medication (TSQM) domain scores range from 0 to 100 with higher scores representing higher satisfaction on that domain. Treatment satisfaction will be assessed at 3 and 6 months.
Up to 6 months after date of first dose of DOAC

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

15 февраля 2019 г.

Первичное завершение (Действительный)

9 июля 2021 г.

Завершение исследования (Действительный)

9 июля 2021 г.

Даты регистрации исследования

Первый отправленный

21 февраля 2022 г.

Впервые представлено, что соответствует критериям контроля качества

21 февраля 2022 г.

Первый опубликованный (Действительный)

2 марта 2022 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

19 июля 2022 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

15 июля 2022 г.

Последняя проверка

1 июля 2022 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • EDX/18/0414(2)

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

НЕТ

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Нет

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

Подписаться