Overview

This trial has been completed.

Condition atrial fibrillation
Treatments vkas, noacs including rivaroxaban (xarelto, bay59-7939), edoxaban, apixaban, dabigatran-etexilate
Phase phase 4
Sponsor Bayer
Start date September 2015
End date October 2016
Trial size 198 participants
Trial identifier NCT02607371, 18242

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Time perspective prospective
Arm
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
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)
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
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)
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)
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)
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)

Primary Outcomes

Measure
AF patients`preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview
time frame: up to 4 weeks

Secondary Outcomes

Measure
Burden associated with anticoagulation treatment measured by the questionnaire ACTS
time frame: Baseline
Health-related quality of life measured by the SF-12 questionnaire
time frame: up to 4 weeks
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: preferred anticoagulation treatment (agent)
time frame: at 9 months
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: HrQoL as defined by the SF-12 score
time frame: at 9 months
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: AF symptoms as measured by the EHRA
time frame: at 9 months
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: TTR (for VKA patients only)
time frame: at 9 months
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Age
time frame: at 9 months
Assessment of factors that may be associated with AF patients preferences towards a specific anticoagulation treatment: Gender
time frame: at 9 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title AF Patient Preferences Towards NOAC Versus VKA Treatment: a Patient Preference Study
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?
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Bayer.