Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation
| Registry | NCT03374540 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 78517 (Actual) |
| Sponsor | Bayer (Industry); collaborators: Janssen Research & Development, LLC |
| Conditions | Nonvalvular Atrial Fibrillation |
| Interventions | Rivaroxaban (Xarelto, BAY59-7939), Vitamin K antagonist (VKA) (Drug) |
| Dates | start 2017-12-01, primary completion 2019-08-30, completion 2019-08-30, first posted 2017-12-15, last updated 2020-08-17 |
| Locations | 1 site in United States |
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All trials for Nonvalvular Atrial Fibrillation All trials of Rivaroxaban (Xarelto, BAY59-7939) All trials of Vitamin K antagonist (VKA)
The overall goal of this study was to evaluate the comparative safety and effectiveness of rivaroxaban vs. vitamin K antagonist (VKA) for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) across risk profiles and comorbidities that reflect everyday clinical practice.
The primary objective in this study was to evaluate the combined end point of stroke or systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs. VKA.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Rivaroxaban | Drug: Rivaroxaban (Xarelto, BAY59-7939) | Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban | |
| Vitamin K antagonist (VKA) | Drug: Vitamin K antagonist (VKA) | Patients who initiated OAC treatment with VKA |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Be oral anticoagulant naive during the 365 days before the day of the first qualifying oral anticoagulant (rivaroxaban or VKA) dispensing, and * Have ≥365 days of continuous medical and prescription coverage before initiation of oral anticoagulation (which serves as the study's baseline period) Exclusion Criteria: * <18 years of age * <2 International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification diagnosis codes for atrial fibrillation * Valvular heart disease * Transient cause of NVAF * Venous thromboembolism * Hip or knee arthroplasty * Malignant cancer * Pregnancy * >1 oral anticoagulant prescribed (on index date)
| Facility | City | Country | Status |
|---|---|---|---|
| Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases | Multiple Locations, Washington | United States |