Patient Convenience Study- NIS RELATE

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 or Pradaxa
    ARM 1: Kind: Experimental
    Label: New Patients / B
    Description: Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
  • Pradaxa (dabigatran) Drug
    Intervention Desc: Pradaxa (dabigatran etexilate)110mg or 150mg
    ARM 1: Kind: Experimental
    Label: New Patients / B
    Description: Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
    ARM 2: Kind: Experimental
    Label: Switch Patients / A
    Description: Patients with non-valvular atrial fibirillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.

Trial Design

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

Trial Population

SEASK Patients with Non valvuar Atrial Fribrillation

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 asessment 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