Trial Condition(s):

Nonvalvular Atrial Fibrillation

Rivaroxaban vs warfarin for SPAF in multi-morbid patients

Bayer Identifier:

19859

ClinicalTrials.gov Identifier:

NCT03374540

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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)

Trial Summary

Enrollment Goal
78517
Trial Dates
black-arrow
Phase
4
Could I receive a placebo?
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases

Many locations, United States, 20001

Status
Completed
 

Trial Design