Anticoagulation Preference by AF Patients Study (PRiSMA-AF)

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Other: VKAs; Other: NOACs including Rivaroxaban (Xarelto, BAY59-7939); Other: Dabigatran-etexilate; Other: Apixaban; Other: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT02607371

18242

Details and patient eligibility

About

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.

Full 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?

Enrollment: 198 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

198 participants in 2 patient groups

Cohort 1 / VKA treatment

Description:

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

Treatment:

Other: VKAs

Cohort 2 / NOAC treatment

Description:

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

Treatment:

Other: NOACs including Rivaroxaban (Xarelto, BAY59-7939)

Other: Edoxaban

Other: Dabigatran-etexilate

Other: Apixaban