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 juli 2022 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Werkelijk)
234
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Glasgow, Verenigd Koninkrijk, G51 4TF
- Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde
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Gloucester, Verenigd Koninkrijk, GL1 3NN
- Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust
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Leicester, Verenigd Koninkrijk, LE1 5WW
- Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust
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London, Verenigd Koninkrijk, SW17 0QT
- St George's Hospital - St George's University Hospital's NHS Foundation Trust
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Newcastle, Verenigd Koninkrijk, NE1 4LP
- Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust
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Newport, Verenigd Koninkrijk, NP20 2UB
- Royal Gwent Hospital - Aneurin Beban University Health Board
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Taunton, Verenigd Koninkrijk, TA1 5DA
- Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust
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Yeovil, Verenigd Koninkrijk, BA21 4AT
- Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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
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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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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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
Tijdsspanne: 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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.
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12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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
Tijdsspanne: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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The time from AF diagnosis until stroke will be assessed.
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Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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Stroke Severity In Participants Presenting With A First Stroke with Atrial Fibrillation (AF) Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
Tijdsspanne: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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.
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Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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
Tijdsspanne: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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.
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Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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Number of Participants Receiving Concomitant Medications At Time of First Stroke and Newly Prescribed Within 1 Month After Stroke
Tijdsspanne: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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.
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Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
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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
Tijdsspanne: Within 1 month after stroke
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Anticoagulant medications may include apixaban, edoxaban, rivaroxaban, warfarin, dabigatran, and other.
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Within 1 month after stroke
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Time From Stroke to First Dose of Direct Oral Anticoagulant (DOAC) in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Tijdsspanne: From stroke to first dose of DOAC, up to 6 months after date of first dose of DOAC
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The time from stroke to first dose of anticoagulant medication will be assessed.
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From stroke to first dose of DOAC, up to 6 months after date of first dose of DOAC
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Time to Discontinuation of First Direct Oral Anticoagulant (DOAC) Treatment in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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The time to discontinuation of anticoagulant medication will be assessed.
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Up to 6 months after date of first dose of DOAC
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Number of Participants Receiving Clinical Assessments in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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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.
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Up to 6 months after date of first dose of DOAC
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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
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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Secondary visits will include inpatient, outpatient, and accident and emergency.
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Up to 6 months after date of first dose of DOAC
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Duration of Inpatient Stays in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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The length of inpatient hospital stays will be assessed.
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Up to 6 months after date of first dose of DOAC
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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
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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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.
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Up to 6 months after date of first dose of DOAC
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Number of Participants Taking Direct Oral Anticoagulant (DOAC) Medication Within Past 7 Days in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
Tijdsspanne: Within past 7 days
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Anticoagulant medication may include apixaban, edoxaban, rivaroxaban, warfarin, dabigatran, and other.
DOAC medication will be assessed at 3 and 6 months.
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Within past 7 days
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Mean Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score Post-first Direct Oral Anticoagulant Dose
Tijdsspanne: Up to 6 months after date of first dose of DOAC
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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.
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Up to 6 months after date of first dose of DOAC
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Medewerkers en onderzoekers
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Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
15 februari 2019
Primaire voltooiing (Werkelijk)
9 juli 2021
Studie voltooiing (Werkelijk)
9 juli 2021
Studieregistratiedata
Eerst ingediend
21 februari 2022
Eerst ingediend dat voldeed aan de QC-criteria
21 februari 2022
Eerst geplaatst (Werkelijk)
2 maart 2022
Updates van studierecords
Laatste update geplaatst (Werkelijk)
19 juli 2022
Laatste update ingediend die voldeed aan QC-criteria
15 juli 2022
Laatst geverifieerd
1 juli 2022
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- EDX/18/0414(2)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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