Clinical trial NCT02960880: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
Official title: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2016-11-10
Enrollment: 99999
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.


Eligibility criteria: 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 \[4 quarters prior to index date\]

Primary outcomes:
measure: Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
measure: Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Secondary outcomes:
measure: Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
measure: Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
measure: Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
measure: Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis
timeFrame: Within time of drug exposure (Retrospective period of 5 years and 3 months)
Other outcomes:
Locations:
city: Multiple Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: