Trial Condition(s):

Atrial Fibrillation

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

Bayer Identifier:

18735

ClinicalTrials.gov Identifier:

NCT02960880

EudraCT Number:

Not Available

Study Completed

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.

Inclusion Criteria
- First dispense date of Rivaroxaban (15mg or 20mg - PZN based) or Phenprocoumon (PZN based) between January 1, 2012 and December 31, 2015
- At least two verified outpatient diagnoses or one inpatient diagnosis (main or secondary diagnosis) of NVAF (ICD-10 GM I48.0/I48.1/I48.2/I48.9) in the individual time frame of 4 quarters before the index date (pre-index period) or within the index quarter
- Patients will be required to have 4 quarters of enrollment for the assessment of baseline characteristics and be observable and insured in the database for at least one day after their individual index date (post-index period)
- ≥ 18 years of age
Exclusion Criteria
- Patients with valvular AF [4 quarters prior to the index date]
- Pregnancy [4 quarters prior to index date]
- Malignant cancers [4 quarters prior to the index date or “condition after”]
- Transient cause of AF [4 quarters prior to index date]
- Patients with VTE (pulmonary embolism or DVT) [60 days before index]
- Patients with major surgery defined as hip or knee replacement [60 days before index]
- Prescriptions of OACs (Rivaroxaban, VKA, Dabigatran, Apixaban) before index date [4 quarters prior to index date]
- Patients receiving more than one anticoagulant substance (Apixaban, Dabigatran, Rivaroxaban or Phenprocoumon) or more than one dosage of a substance on the index date
- For sensitivity analysis : Patient with any of the events defined in the combined endpoints [4 quarters prior to index date or “condition after”
- Patients with dialysis [4 quarters prior to index date]

Trial Summary

Enrollment Goal
99999
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 

Trial Design