Real-Life Evidence on Stroke Prevention in SPAF "RELIEF"

Completed

Phase N/A Results N/A

Trial Description

To obtain a better understanding on the comparative effectiveness of rivaroxaban and vitamin K antagonists (VKA) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF) in a real-life setting

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY59-7939) Drug
    Intervention Desc: As prescribed by treating physicians
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: NVAF patients who were initiated on rivaroxaban for stroke prevention
  • Vitamin K antagonists Drug
    Intervention Desc: As prescribed by treating physicians
    ARM 1: Kind: Experimental
    Label: Vitamin K antagonists (VKA)
    Description: NVAF patients who were initiated on VKA (predominately phenprocoumon in Germany) for stroke prevention

Trial Design

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

Trial Population

Patients with non-valvular atrial fibrillation (NVAF)

Outcomes

Type Measure Time Frame Safety Issue
Primary Time to first occurrence of any of the following: Ischemic stroke (IS), Transient ischemic attack (TIA), Intracerebral hemorrhage (IH), Other non-traumatic intracranial hemorrhage including subdural hemorrhage, Myocardial infarction (MI) Within 1 year after treatment start No
Secondary Time to first occurrence of IS Within 1 year after treatment start No
Secondary Time to first occurrence of TIA Within 1 year after treatment start No
Secondary Time to first occurrence of IH Within 1 year after treatment start No
Secondary Time to first occurrence of Other non-traumatic intracranial hemorrhage including subdural hemorrhage Within 1 year after treatment start No
Secondary Time to first occurrence of MI Within 1 year after treatment start No
Secondary Incidence density in study population of IS Within 1 year after treatment start No
Secondary Incidence density in study population of TIA Within 1 year after treatment start No
Secondary Incidence density in study population of IH Within 1 year after treatment start No
Secondary Incidence density in study population of Other non-traumatic intracranial hemorrhage including subdural hemorrhage Within 1 year after treatment start No
Secondary Incidence density in study population of MI Within 1 year after treatment start No
Secondary Incidence density in study population of any of the following: IS, TIA, IH, Other non-traumatic intracranial hemorrhage including subdural hemorrhage, MI Within 1 year after treatment start No

Sponsors