Atrial Fibrillation Patient Preference Study (PRiSMA-AF)

AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study.

The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).

VKA (Waran®) will be compared to Rivaroxaban.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: VKA: Warfarin (Waran); Drug: NOAC: Rivaroxaban (Xarelto, BAY59-7939); Drug: NOAC: Dabigatran etexilate; Drug: NOAC: Apixaban; Drug: NOAC: Edoxaban; Drug: NOAC: Lixiana

Detailed Description

The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish AF patients being treated either with a VKA or with a NOAC:

• Which attributes of a medication to prevent stroke do AF patients view as important?
• Do AF patients have a preference regarding the attributes of the medication options VKA or NOAC and, in case of NOACs, with regards to rivaroxaban attributes?
• Are there subgroups of AF patients whose preference for one of the medication options appears above or below average?
• What is the quality of life of Swedish AF patients? Are there subgroups with differences in their quality of life (for example: subgroups of patients with different CHA2DS2-VASc scores)?
• Which burden do Swedish AF patients experience in association with their anticoagulation therapy? Are there differences in the burden of treatment (ACTS) between patients treated with VKA or with NOACs?

• Study Type: Observational
• Enrollment (Actual): 382

Contacts and Locations

Study Locations

• Sweden
  • Multiple Locations, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients in primary care / internal medicine specialist practices or cardiology outpatient clinics in Sweden.

Description

Inclusion Criteria:

Inclusion criteria for AF patients in both the NOAC and the VKA groups:

• Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
• Age of at least 18 years at time of study inclusion,
• Generally willingness (informed consent) and ability to fill out a survey on satisfaction with treatment and quality of life, and to conduct a structured phone interview (approx. 20 - 30 min) in Swedish language.

Additional inclusion criterion for Group 1 (NOAC):

• Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke & systemic embolism for at least the previous 3 months.

Additional inclusion criterion for Group 2 (VKA):

• Continuous anticoagulation with a VKA for prevention of Stroke & systemic embolism for at least the previous 3 months.

Exclusion Criteria:

Exclusion criteria for both groups:

• Participation in another

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VKA treatment of AF / Cohort 1; A sample of about 200 patients with non-valvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion	Drug: VKA: Warfarin (Waran); VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
NOAC treatment of AF / Cohort 2; A sample of about 200 patients with non-valvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion	Drug: NOAC: Rivaroxaban (Xarelto, BAY59-7939); NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study); Drug: NOAC: Dabigatran etexilate; NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study); Drug: NOAC: Apixaban; NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study); Drug: NOAC: Edoxaban; NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study); Drug: NOAC: Lixiana; NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Frequency of intake (once/twice daily)	up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of International normalized ratio (INR) monitoring/dose adjustment (yes/no)	up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Need of bridging (yes/no)	up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Interactions with food/drugs (yes/no)	up to 4 weeks after enrollment of patient
AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview: Distance to treating physician (1km or 50km).	up to 4 weeks after enrollment of patient

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-related burden of treatment with anticoagulants measured by the Benefit and Burden Scale of the Anti-clot Treatment Scale (ACTS)		Baseline
Patient's quality of life measured using the SF-12 (interview version)	Variables: Physical/psychological domain according to SF-12 questionnaire	up to 4 weeks after enrollment of patient
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Age		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Gender		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: preferred Anticoagulation treatment (agent)		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Lifestyle variables		Baseline
Assessment of factors that may be associated with AF patients' preferences towards a specific anticoagulation treatment: Previous switch of anticoagulation treatment		Baseline

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): January 26, 2017
• Study Completion (Actual): February 16, 2017

Study Registration Dates

• First Submitted: October 16, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Patient treatment preference; NOAC; VKA; non-valvular Atrial Fibrillation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Dabigatran; Apixaban; Edoxaban; Warfarin
• Other Study ID Numbers: 18377