Clinical trial NCT05262322: Study to Evaluate the Use of Direct Oral Anticoagulants in UK Clinical Practice For Patients With a First Stroke Attributable to Nonvalvular Atrial Fibrillation
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Direct oral anticoagulants
Edoxaban
Apixaban
Rivaroxaban
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
First posted: 2022-03-02
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
Secondary outcomes:
measure: 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
timeFrame: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
measure: Stroke Severity In Participants Presenting With A First Stroke with Atrial Fibrillation (AF) Who Have Not Received Anticoagulation Within 12 Months Prior to Stroke
timeFrame: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
measure: 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
timeFrame: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
measure: Number of Participants Receiving Concomitant Medications At Time of First Stroke and Newly Prescribed Within 1 Month After Stroke
timeFrame: Approximately 12 month period prior to the date of diagnosis of a first ischaemic stroke attributable to nonvalvular AF
measure: 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
timeFrame: Within 1 month after stroke
measure: Time From Stroke to First Dose of Direct Oral Anticoagulant (DOAC) in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
timeFrame: From stroke to first dose of DOAC, up to 6 months after date of first dose of DOAC
measure: Time to Discontinuation of First Direct Oral Anticoagulant (DOAC) Treatment in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
timeFrame: Up to 6 months after date of first dose of DOAC
measure: Number of Participants Receiving Clinical Assessments in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
timeFrame: Up to 6 months after date of first dose of DOAC
measure: 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
timeFrame: Up to 6 months after date of first dose of DOAC
measure: Duration of Inpatient Stays in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
timeFrame: Up to 6 months after date of first dose of DOAC
measure: 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
timeFrame: Up to 6 months after date of first dose of DOAC
measure: Number of Participants Taking Direct Oral Anticoagulant (DOAC) Medication Within Past 7 Days in Participants Who Are Initiated on Apixaban, Edoxaban, or Rivaroxaban
timeFrame: Within past 7 days
measure: Mean Absolute Treatment Satisfaction Questionnaire for Medication (TSQM) Score Post-first Direct Oral Anticoagulant Dose
timeFrame: Up to 6 months after date of first dose of DOAC
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital - NHS Greater Glasgow and Clyde
city: Gloucester
country: United Kingdom
facility: Gloucestershire Royal Hospital - Gloucestershire Hospitals NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: Leicester Royal Infirmary - University Hospitals of Leicester NHS Trust
city: London
country: United Kingdom
facility: St George's Hospital - St George's University Hospital's NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Royal Victoria Infirmary - Newcastle upon Tyne Hospitals NHS Foundation Trust
city: Newport
country: United Kingdom
facility: Royal Gwent Hospital - Aneurin Beban University Health Board
city: Taunton
country: United Kingdom
facility: Musgrove park Hospital - Taunton and Somerset NHS Foundation Trust
city: Yeovil
country: United Kingdom
facility: Yeovil District Hospital - Yeovil District Hospital NHS Foundation Trust
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: