Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists

Completed

Phase N/A Results N/A

Trial Description

The aim of this study is to assess the real world comparative effectiveness of Rivaroxaban prescribed in non-valvular atrial fibrillation (NVAF) routine care patients in Germany.

Conditions

Interventions

  • Rivaroxaban (Xarelto, BAY597939) Drug
    Intervention Desc: 15mg, 20mg
    ARM 1: Kind: Experimental
    Label: Rivaroxaban
    Description: NVAF patients who were newly initiated on Rivaroxaban for stroke prevention
  • Phenprocoumon (branded and generics) Drug
    Intervention Desc: Individually adjusted dose
    ARM 1: Kind: Experimental
    Label: Phenprocoumon
    Description: NVAF patients who were newly initiated on Phenprocoumon for stroke prevention

Trial Population

Patients newly initiated with Rivaroxaban or Phenprocoumon with an NVAF diagnosis from January 1, 2012 through December 31, 2015. Patients will be identified from the HRI research database, a complete longitudinal dataset of patients under statutory health insurance in Germany.

Outcomes

Type Measure Time Frame Safety Issue
Primary Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)
Primary Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis Within time of drug exposure (Retrospective period of 5 years and 3 months)

Sponsors