Study Completed

Nonvalvular Atrial Fibrillation

Bayer Identifier:

19859

ClinicalTrials.gov Identifier:

NCT03374540

EudraCT Number:

Not Available

EU CT Number:

Not Available

Rivaroxaban vs warfarin for SPAF in multi-morbid patients

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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

December 2017 - August 2019

Phase

Phase 4

Could I Receive a placebo

Products

Xarelto (Rivaroxaban, BAY59-7939)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases	Many locations, 20001, United States

Primary Outcome

Stroke or systemic embolism (SSE)
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Major bleeding
Without access to clinical information and event adjudication in administrative claims data, major bleeding will operationalized as hospital-related bleeding using a clinically validated algorithm
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017

Secondary Outcome

Hemorrhagic stroke
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Ischemic stroke
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Subtypes of major bleeding
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Acute kidney injury
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017
Renal impairment
Time Frame:
Retrospective analysis from January 1, 2011 to December 31, 2017

Trial design

Comparative effectiveness of rivaroxaban and warfarin for stroke prevention in multi-morbid patients with nonvalvular atrial fibrillation

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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