check_circleStudy Completed

Atrial Fibrillation

Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists

Trial purpose

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.

Key Participants Requirements

Sex

Both

Age

18 - N/A

Trial summary

Enrollment Goal
99999
Trial Dates
October 2016 - December 2016
Phase
N/A
Could I Receive a placebo
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No
  • Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
    date_rangeTime Frame:
    Within time of drug exposure (Retrospective period of 5 years and 3 months)
    enhanced_encryption
    Safety Issue:
    No

Trial design

Real-world comparative effectiveness of stroke prevention in patients with atrial fibrillation treated with rivaroxaban vs. vitamin k antagonists
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A