Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

Completed

Conditions studied: Nonvalvular Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT03374540

Run by

Bayer

People needed

78517

Starts

2017-12-01

Expected to finish

2019-08-30

Last updated by the study team

2020-08-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• <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)

Where it is running

• Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases — Multiple Locations, Washington, United States

Full record on ClinicalTrials.gov

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