Atrial Fibrillation Patient Preference Study (PRiSMA-AF)

Bayer

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Drug: NOAC: Lixiana; Drug: NOAC: Dabigatran etexilate; Drug: NOAC: Rivaroxaban (Xarelto, BAY59-7939); Drug: VKA: Warfarin (Waran); Drug: NOAC: Apixaban; Drug: NOAC: Edoxaban

Study type: Observational

Funder types: Industry

Identifiers

NCT02611635

18377

Details and patient eligibility

About

The main research question of this patient survey is to assess AF patients' preferences associated with different attributes which describe the different available anticoagulation treatment options (VKA or NOACs and, in case of NOACs, Apixaban, Dabigatran or Rivaroxaban).

VKA (Waran®) will be compared to Rivaroxaban.

Full description

The objective of this study is to investigate the following research questions in a cross-sectional survey of Swedish 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 Swedish 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 Swedish 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: 382 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 Swedish 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

Trial design

382 participants in 2 patient groups

VKA treatment of AF / Cohort 1

Description:

A sample of about 200 patients with non-valvular atrial fibrillation who are treated with VKAs for at least three months at date of study inclusion

Treatment:

Drug: VKA: Warfarin (Waran)

NOAC treatment of AF / Cohort 2

Description:

A sample of about 200 patients with non-valvular atrial fibrillation who are treated with NOACs for at least three months at date of study inclusion

Treatment:

Drug: NOAC: Apixaban

Drug: NOAC: Rivaroxaban (Xarelto, BAY59-7939)

Drug: NOAC: Dabigatran etexilate

Drug: NOAC: Lixiana

Drug: NOAC: Edoxaban