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

Atrial Fibrillation Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05262322
• Other study ID #: EDX/18/0414(2)
• Status: Completed
• Start date: February 15, 2019
• Est. completion date: July 9, 2021

Study information

• Verified date: July 2022
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: July 9, 2021
• Est. primary completion date: July 9, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Edoxaban
This was a non-interventional, observational study. No drug was administered in this study.
• Apixaban
This was a non-interventional, observational study. No drug was administered in this study.
• Rivaroxaban
This was a non-interventional, observational study. No drug was administered in this study.

Locations

Country	Name	City	State
United Kingdom	Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde	Glasgow
United Kingdom	Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust	Gloucester
United Kingdom	Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust	Leicester
United Kingdom	St George's Hospital - St George's University Hospital's NHS Foundation Trust	London
United Kingdom	Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust	Newcastle
United Kingdom	Royal Gwent Hospital - Aneurin Beban University Health Board	Newport
United Kingdom	Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust	Taunton
United Kingdom	Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust	Yeovil

Sponsors (1)

Lead Sponsor	Collaborator
Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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	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
Secondary	Stroke Severity In Participants Presenting With A First Stroke with Atrial Fibrillation (AF) Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke	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
Secondary	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	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
Secondary	Number of Participants Receiving Concomitant Medications At Time of First Stroke and Newly Prescribed Within 1 Month After Stroke	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
Secondary	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	Anticoagulant medications may include apixaban, edoxaban, rivaroxaban, warfarin, dabigatran, and other.	Within 1 month after stroke
Secondary	Time From Stroke to First Dose of Direct Oral Anticoagulant (DOAC) in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban	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
Secondary	Time to Discontinuation of First Direct Oral Anticoagulant (DOAC) Treatment in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban	The time to discontinuation of anticoagulant medication will be assessed.	Up to 6 months after date of first dose of DOAC
Secondary	Number of Participants Receiving Clinical Assessments in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban	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
Secondary	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	Secondary visits will include inpatient, outpatient, and accident and emergency.	Up to 6 months after date of first dose of DOAC
Secondary	Duration of Inpatient Stays in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban	The length of inpatient hospital stays will be assessed.	Up to 6 months after date of first dose of DOAC
Secondary	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	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
Secondary	Number of Participants Taking Direct Oral Anticoagulant (DOAC) Medication Within Past 7 Days in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban	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
Secondary	Mean Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score Post-first Direct Oral Anticoagulant Dose	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