Anticoagulation Preference by AF Patients Study

NCT02607371 | Completed

• 1 other identifier: 18242
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Patient treatment preference; Non-valvular Atrial Fibrillation; NOAC; VKA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

Study Arms (2)

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

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); Other: Edoxaban; Other: Apixaban; Other: Dabigatran-etexilate

Interventions

VKAs OTHER

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 1 / VKA treatment

NOACs including Rivaroxaban (Xarelto, BAY59-7939) OTHER

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)

Cohort 2 / NOAC treatment

Edoxaban OTHER

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)

Cohort 2 / NOAC treatment

Apixaban OTHER

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)

Cohort 2 / NOAC treatment

Dabigatran-etexilate OTHER

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)

Cohort 2 / NOAC treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Patients with a confirmed diagnosis of nonvalvular atrial fibrillation (persistent, paroxysmal, permanent),
• 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.
• Continuous anticoagulation with either Apixaban, or Dabigatran or Rivaroxaban for prevention of Stroke \& systemic embolism for at least the previous 3 months.
• Continuous anticoagulation with a VKA for prevention of Stroke \& systemic embolism for at least the previous 3 months.

You may not qualify if:

• Participation in another study (clinical intervention / observational) within the 3 months prior to enrollment,

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Unknown Facility

Many Locations, Switzerland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; edoxaban; apixaban; Dabigatran

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2015
• First Posted: November 18, 2015
• Study Start: August 27, 2015
• Primary Completion: October 15, 2016
• Study Completion: October 15, 2016
• Last Updated: September 14, 2017

Record last verified: 2017-09

Locations

CH (1)