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 de julio de 2022 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
234
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Glasgow, Reino Unido, G51 4TF
- Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde
-
Gloucester, Reino Unido, GL1 3NN
- Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust
-
Leicester, Reino Unido, LE1 5WW
- Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust
-
London, Reino Unido, SW17 0QT
- St George's Hospital - St George's University Hospital's NHS Foundation Trust
-
Newcastle, Reino Unido, NE1 4LP
- Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust
-
Newport, Reino Unido, NP20 2UB
- Royal Gwent Hospital - Aneurin Beban University Health Board
-
Taunton, Reino Unido, TA1 5DA
- Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust
-
Yeovil, Reino Unido, BA21 4AT
- Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra no probabilística
Población de estudio
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.
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
This was a non-interventional, observational study.
No drug was administered in this study.
This was a non-interventional, observational study.
No drug was administered in this study.
This was a non-interventional, observational study.
No drug was administered in this study.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de febrero de 2019
Finalización primaria (Actual)
9 de julio de 2021
Finalización del estudio (Actual)
9 de julio de 2021
Fechas de registro del estudio
Enviado por primera vez
21 de febrero de 2022
Primero enviado que cumplió con los criterios de control de calidad
21 de febrero de 2022
Publicado por primera vez (Actual)
2 de marzo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
19 de julio de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
15 de julio de 2022
Última verificación
1 de julio de 2022
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades cardíacas
- Enfermedades cardiovasculares
- Arritmias Cardiacas
- Fibrilación auricular
- Mecanismos moleculares de acción farmacológica
- Inhibidores de enzimas
- Inhibidores de la proteasa
- Inhibidores del factor Xa
- Antitrombinas
- Inhibidores de la serina proteinasa
- Anticoagulantes
- Rivaroxabán
- Apixabán
- Edoxabán
Otros números de identificación del estudio
- EDX/18/0414(2)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .