Trial Condition(s):

Atrial Fibrillation

Anticoagulation preference by AF patients study (PRiSMA-AF)

Bayer Identifier:

18242

ClinicalTrials.gov Identifier:

NCT02607371

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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 Summary

Enrollment Goal
198
Trial Dates
black-arrow
Phase
4
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, Switzerland

Status
Completed
 

Trial Design