Patient Convenience Study (RE-SONANCE)

Completed

Phase N/A Results N/A

Trial Description

The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Conditions

Trial Design

  • Observation: Cohort
  • Perspective: Prospective
  • Sampling: Non-Probability Sample

Trial Population

European patients with non valvular atrial fibrillation

Outcomes

Type Measure Time Frame Safety Issue
Primary Mean Perception of Anticoagulant treatment Questionnaire, part 2 (PACT-Q2) scores, for patients in cohort A, at last assessment compared to baseline assessment 180 days No
Primary Mean PACT-Q2 scores, for patients in cohort A, at second assessment compared to baseline assessment 40 days No
Primary Mean PACT-Q2 scores, for patients in cohort B, at last assessment compared between treatment groups 180 days No
Primary Mean PACT-Q2 scores, for patients in cohort B, at second assessment compared between treatment groups 40 days No
Primary Gender 1 day No
Primary CHA2DS2-VASc score 1 day No
Primary HAS-BLED score (modified HAS-BLED for newly initiated patients) 1 day No
Primary Kidney function (creatinine clearance) 1 day No
Primary Co-morbidities 1 day No
Primary Concomitant therapies 1 day No
Primary Dosing of Pradaxa 1 day No
Primary Duration of previous VKA treatment (for Cohort A) 1 day No
Primary Age 1 day No
Secondary Mean PACT-Q2 scores, for patients in cohort A, at last assessment compared to second assessment 180 days No
Secondary Description of perception of anticoagulant treatment questionnaire, Part 1 (PACT-Q1) at baseline 1 day No
Primary Stroke- and/or bleeding related risk factors in medical history and at baseline 1 day No

Sponsors