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

NCT02960880 | Completed

• 1 other identifier: 18735
• Study Type: observational
• Target: 99,999
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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)

Study Arms (2)

Rivaroxaban

NVAF patients who were newly initiated on Rivaroxaban for stroke prevention

Drug: Rivaroxaban (Xarelto, BAY597939)

Phenprocoumon

NVAF patients who were newly initiated on Phenprocoumon for stroke prevention

Drug: Phenprocoumon (branded and generics)

Interventions

Rivaroxaban (Xarelto, BAY597939) DRUG

15mg, 20mg

Rivaroxaban

Phenprocoumon (branded and generics) DRUG

Individually adjusted dose

Phenprocoumon

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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 \[4 quarters prior to index date\]

Sponsors & Collaborators

• Bayer: lead
• Janssen Research & Development, LLC: collaborator

Study Sites (1)

Unknown Facility

Multiple Locations, Germany

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; Phenprocoumon

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2016
• First Posted: November 10, 2016
• Study Start: October 15, 2016
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: December 26, 2017

Record last verified: 2017-12

Locations

DE (1)