PRiSMA-AF: Anticoagulation Preference by AF Patients Study

Sponsor

Bayer (Industry)

Overall Status

Completed

CT.gov ID

NCT02607371

Collaborator

(none)

198

Enrollment

Location

13.6

Actual Duration (Months)

14.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Atrial Fibrillation	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 Design

Study Type:

Observational

Actual Enrollment :

198 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 27, 2015

Actual Primary Completion Date :

Oct 15, 2016

Actual Study Completion Date :

Oct 15, 2016

Arms and Interventions

Arm	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)

Arm

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

Other: Apixaban

Other: Dabigatran-etexilate

Outcome Measures

Primary Outcome Measures

AF patients'preferences towards anticoagulation treatment with either VKAs or NOACs measured with a DCE (discrete choice experiment) design in a phone interview [up to 4 weeks]
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).

Secondary Outcome Measures

Burden associated with anticoagulation treatment measured by the questionnaire ACTS [Baseline]
Health-related quality of life measured by the SF-12 questionnaire [up to 4 weeks]
Variables: Physical/psychological domain according to SF-12 questionnaire
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.