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

Atrial Fibrillation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02960880
• Other study ID #: 18735
• Status: Completed
• Phase: N/A
• First received: October 12, 2016
• Last updated: December 22, 2017
• Start date: October 15, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: December 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99999
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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]

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Rivaroxaban (Xarelto, BAY597939)
15mg, 20mg
• Phenprocoumon (branded and generics)
Individually adjusted dose

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Janssen Research & Development, LLC

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)

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