Anticoagulation Preference by AF Patients 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 (Atrial Fibrillation) patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (Vitamin K Antagonists [VKA] or New Oral Anticoagulants [NOACs] and, in case of NOACs, Apixaban, Dabigatran, Edoxaban or Rivaroxaban).

VKAs (Marcoumar®, Sintrom ®) will be grouped together and compared to Rivaroxaban.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: VKAs; Other: NOACs including Rivaroxaban (Xarelto, BAY59-7939); Other: Edoxaban; Other: Apixaban; Other: Dabigatran-etexilate

Detailed Description

The objective of this study is to investigate the following research questions in a cross-sectional survey of German-speaking Swiss 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 Swiss German-speaking 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 German-speaking Swiss 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): 198

Contacts and Locations

Study Locations

• Switzerland
  • Many Locations, Switzerland

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 / general outpatient practices and outpatient clinics in German-speaking Switzerland.

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 German 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 (clinical intervention / observational) within the 3 months prior to enrollment,
• Interruption of VKA/NOAC therapy of more than 2 weeks (bridging) within the prior 3 months or planned bridging in 4 weeks after study inclusion.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1 / VKA treatment; A sample of about 200 patients with nonvalvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion	Other: VKAs; 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)
Cohort 2 / NOAC treatment; A sample of about 200 patients with nonvalvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion	Other: NOACs including 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); Other: 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); Other: 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); Other: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	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	DCE is based on the following attributes /attribute levels:; Frequency of intake (once/twice daily),; Need of INR monitoring/dose adjustment (yes/no),; Need of bridging (yes/no),; Interactions with food/drugs (yes/no),; Distance to treating physician (1km or 15km).	up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Burden associated with anticoagulation treatment measured by the questionnaire ACTS		Baseline
Health-related quality of life measured by the SF-12 questionnaire	Variables: Physical/psychological domain according to SF-12 questionnaire	up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)		up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score		up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA		up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)		up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age		up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender		up to 4 weeks

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): August 27, 2015
• Primary Completion (Actual): October 15, 2016
• Study Completion (Actual): October 15, 2016

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: November 16, 2015
• First Posted (Estimate): November 18, 2015

Study Record Updates

• Last Update Posted (Actual): September 14, 2017
• Last Update Submitted That Met QC Criteria: September 13, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Keywords: Patient treatment preference; Non-valvular Atrial Fibrillation; NOAC; VKA
• 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
• Other Study ID Numbers: 18242

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No