Drug Persistence/Adherence in Patients Treated With Dabigatran or VKA for Stroke Prevention in Non Valvular Atrial Fibrillation (SPAF)

Active, not recruiting

Phase N/A Results N/A

Trial Description

1600 AF patients receiving Pradaxa or VKA for stroke prevention will be followed up for 12 months in quarterly visits. Prescriptions, adverse events and (if applicable) reasons for definitive treatment discontinuation will be collected. At 6 months, patient adherence will be assessed, using the Morisky Score.

Conditions

Interventions

  • Phenprocoumon (Marcoumar, Marcumar and Falithrom))Drug
    Intervention Desc: International Normalized Ratio (INR) 2-3
    ARM 1: Kind: Experimental
    Label: B
  • Dabigatran etexilate Drug
    Intervention Desc: 150 mg or 110 mg capsules twice daily
    ARM 1: Kind: Experimental
    Label: A

Trial Design

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

Trial Population

AF patients

Outcomes

Type Measure Time Frame Safety Issue
Primary Proportion of patients being treated at 12 months with anticoagulation initially started, defined as Kaplan Meier estimate at 12 months for persistence, stratified for dabigatranetexilate and VKA. up to 12 months No
Secondary Proportion of patients with low, medium or high adherence at the timepoint of 6 months-visit, stratified for dabigatranetexilate and VKA; categorisation acc. to Morisky questionnaire. up to 6 months No
Secondary Reasons for definitive treatment discontinuation. up to 12 months No

Sponsors