Patient Convenience Study

Active, not recruiting

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 mg or 150 mg twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).

Conditions

Interventions

  • Vitamin K antagonist Drug
    Intervention Desc: Vitamin K antagonist, various
    ARM 1: Kind: Experimental
    Label: New AF patients / B
  • Pradaxa (dabigatran) Drug
    Intervention Desc: Pradaxa (dabigatran etexilate) 110 mg or 150mg
    ARM 1: Kind: Experimental
    Label: New AF patients / B

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 Patient characterization at baseline 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) items at baseline 1 day No

Sponsors