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

NCT05262322 | Completed

• 1 other identifier: EDX/18/0414(2)
• Study Type: observational
• Target: 234
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Direct oral anticoagulants; Edoxaban; Apixaban; Rivaroxaban

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (13)

• 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

  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

  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

  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

  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

  Within 1 month after stroke

Study Arms (2)

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.

Drug: Edoxaban; Drug: Apixaban; Drug: Rivaroxaban

Interventions

Edoxaban DRUG

This was a non-interventional, observational study. No drug was administered in this study.

Subset of All Participants (Group 2; Prospective)

Apixaban DRUG

This was a non-interventional, observational study. No drug was administered in this study.

Subset of All Participants (Group 2; Prospective)

Rivaroxaban DRUG

This was a non-interventional, observational study. No drug was administered in this study.

Subset of All Participants (Group 2; Prospective)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• \- 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo UK Ltd, a Daiichi Sankyo Company: lead

Study Sites (8)

Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde

Glasgow, G51 4TF, United Kingdom

Location

Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust

Gloucester, GL1 3NN, United Kingdom

Location

Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

Location

St George's Hospital - St George's University Hospital's NHS Foundation Trust

London, SW17 0QT, United Kingdom

Location

Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle, NE1 4LP, United Kingdom

Location

Royal Gwent Hospital - Aneurin Beban University Health Board

Newport, NP20 2UB, United Kingdom

Location

Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

Location

Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust

Yeovil, BA21 4AT, United Kingdom

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

edoxaban; apixaban; Rivaroxaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: March 2, 2022
• Study Start: February 15, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (8)