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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02960880

Enrollment

99999

Registered

2016-11-10

Start date

2016-10-15

Completion date

2016-12-31

Last updated

2017-12-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Fibrillation

Keywords

Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF

Brief summary

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.

Interventions

DRUGRivaroxaban (Xarelto, BAY597939)

15mg, 20mg

DRUGPhenprocoumon (branded and generics)

Individually adjusted dose

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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 \[4 quarters prior to index date\]

Design outcomes

Primary

Measure	Time frame
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)
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

Measure	Time frame
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)
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)
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)
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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026