Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients



Status:Active, not recruiting
Conditions:Atrial Fibrillation
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - Any
Updated:3/13/2019
Start Date:December 1, 2017
End Date:March 29, 2019

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Trial Summary
Trial Overview
Inclusion Criteria

Comparative Effectiveness of Rivaroxaban and Warfarin for Stroke Prevention in Multi-morbid Patients With Nonvalvular Atrial Fibrillation

The overall goal of this study is 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 is to evaluate the combined end point of stroke or
systemic embolism (SSE), and major bleeding in NVAF patients treated with rivaroxaban vs.
VKA.


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)
We found this trial at
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Multiple Locations, Washington 20001
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