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

Completed

• Conditions: Atrial Fibrillation
• Interventions: Drug: Rivaroxaban (Xarelto, BAY597939); Drug: Phenprocoumon (branded and generics)

• Registration Number: NCT02960880
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-10-12
• Study Start: 2016-10-15
• Study First Submitted QC: 2016-11-08
• Study First Posted: 2016-11-10
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-22
• Last Update Posted: 2017-12-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99999

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

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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]

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rivaroxaban	Rivaroxaban (Xarelto, BAY597939)	NVAF patients who were newly initiated on Rivaroxaban for stroke prevention
Phenprocoumon	Phenprocoumon (branded and generics)	NVAF patients who were newly initiated on Phenprocoumon for stroke prevention

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)