Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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 lipca 2022 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Obserwacyjny

Zapisy (Rzeczywisty)

234

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka bez prawdopodobieństwa

Badana populacja

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.

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Kohorty i interwencje

Grupa / Kohorta
Interwencja / Leczenie
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.
Lek: Edoxaban
This was a non-interventional, observational study. No drug was administered in this study.
Lek: Apixaban
This was a non-interventional, observational study. No drug was administered in this study.
Lek: Rivaroxaban
This was a non-interventional, observational study. No drug was administered in this study.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

15 lutego 2019

Zakończenie podstawowe (Rzeczywisty)

9 lipca 2021

Ukończenie studiów (Rzeczywisty)

9 lipca 2021

Daty rejestracji na studia

Pierwszy przesłany

21 lutego 2022

Pierwszy przesłany, który spełnia kryteria kontroli jakości

21 lutego 2022

Pierwszy wysłany (Rzeczywisty)

2 marca 2022

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 lipca 2022

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

15 lipca 2022

Ostatnia weryfikacja

1 lipca 2022

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • EDX/18/0414(2)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj