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

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.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Drug: Rivaroxaban (Xarelto, BAY597939); Drug: Phenprocoumon (branded and generics)

• Study Type: Observational
• Enrollment (Actual): 99999

Contacts and Locations

Study Locations

• Germany
  • Multiple Locations, Germany

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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]

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rivaroxaban; NVAF patients who were newly initiated on Rivaroxaban for stroke prevention	Drug: Rivaroxaban (Xarelto, BAY597939); 15mg, 20mg
Phenprocoumon; NVAF patients who were newly initiated on Phenprocoumon for stroke prevention	Drug: Phenprocoumon (branded and generics); Individually adjusted dose

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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)

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2016
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: November 8, 2016
• First Posted (Estimate): November 10, 2016

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Rivaroxaban, Phenprocoumon, retrospective cohort study, Non-Valvular Atrial fibrillation, NVAF
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Rivaroxaban; Phenprocoumon
• Other Study ID Numbers: 18735