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

• ClinicalTrials.gov Identifier: NCT02960880
• Recruitment Status: Completed
• First Posted: November 10, 2016
• Last Update Posted: December 26, 2017
• Sponsor: Bayer
• Collaborator: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Bayer

Study Description

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.

Condition or disease	Intervention/treatment
Atrial Fibrillation	Drug: Rivaroxaban (Xarelto, BAY597939); Drug: Phenprocoumon (branded and generics)

Study Design

• Study Type: Observational
• Actual Enrollment: 99999 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Real-world Comparative Effectiveness of Stroke Prevention in Patients With Atrial Fibrillation Treated With Rivaroxaban vs. Vitamin k Antagonists
• Actual Study Start Date: October 15, 2016
• Actual Primary Completion Date: December 31, 2016
• Actual Study Completion Date: December 31, 2016

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :

1. Risk of ischemic stroke estimated as the number of hospitalizations with the ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]
2. Risk of intracranial hemorrhage (ICH) estimated as the number of hospitalizations with the ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]

Secondary Outcome Measures :

1. Risk of ischemic stroke or ICH estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]
2. Risk of systemic embolism (SE) estimated as the number of hospitalizations with the ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]
3. Risk of transient ischemic attack (TIA) estimated as the number of hospitalizations with the ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]
4. Risk of ischemic stroke or SE or TIA estimated as the number of hospitalizations with the respective ICD-10-GM diagnosis [ Time Frame: Within time of drug exposure (Retrospective period of 5 years and 3 months) ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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]

Contacts and Locations

Locations

Germany

Multiple Locations, Germany

Sponsors and Collaborators

Bayer

Janssen Research & Development, LLC

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT02960880
• Other Study ID Numbers: 18735
• First Posted: November 10, 2016
• Last Update Posted: December 26, 2017
• Last Verified: December 2017

Keywords provided by Bayer:

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

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Rivaroxaban; Phenprocoumon; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticoagulants