Trial Condition(s):

Atrial Fibrillation

Atrial Fibrillation patient preference study (PRiSMA-AF)

Bayer Identifier:

18377

ClinicalTrials.gov Identifier:

NCT02611635

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
382
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Sweden

Status
Completed
 

Trial Design