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

Daiichi Sankyo

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: Rivaroxaban; Drug: Apixaban; Drug: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT05262322

EDX/18/0414(2)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

234 participants in 2 patient groups

All Participants (Group 1; Retrospective)

Description:

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)

Description:

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.

Treatment:

Drug: Rivaroxaban

Drug: Edoxaban

Drug: Apixaban