ClinicalTrials.gg
CompletedNCT03374540Updated Aug 17, 2020

Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

An observational study in Nonvalvular Atrial Fibrillation, sponsored by Bayer. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-08-17.

Sponsored by Bayer · Observational

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Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
78,517
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 64 studies in Atrial Fibrillation by Bayer — 1 open to participants now, 1 under way, none of them phase 3. Atrial Fibrillation · Bayer.

Enrollment
10th of 51
78,517 · median 3,055
Started
2017
with 5 others
Observational
51 of 64
none open now
Registered
46th of 64
by date

Among the 64 studies in Atrial Fibrillation by Bayer, this one is the 10th largest by enrollment of the 51 observational ones that give a count, is one of 6 that started in 2017, is one of 51 observational ones, and was the 46th registered.

Atrial Fibrillation

4,009 studies on the registry are indexed under Atrial Fibrillation; 960 are open to participants now.

Browse Atrial Fibrillation studies →

Open to participants now

1 of the 64 studies in Atrial Fibrillation by Bayer is open now, in 8 countries. Recruiting first, the newest first:

By country, each count listing its studies:

Who these studies take

Of the 611 Atrial Fibrillation studies recruiting now, 407 (67%) set no upper age limit and 43 (7%) stop at 75 or younger; 21 take children under 18; 43 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 64 studies in Atrial Fibrillation by Bayer, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Nonvalvular Atrial Fibrillation

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The source population of this study will be all the insured individuals included in the Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases (Truven MarketScan).

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
78,517 participants (actual)
Patient registry
No

Groups and cohorts

  • Rivaroxaban

    Patients who initiated Oral anticoagulant (OAC) treatment with rivaroxaban

    Drug: Rivaroxaban (Xarelto, BAY59-7939)

  • Vitamin K antagonist (VKA)

    Patients who initiated OAC treatment with VKA

    Drug: Vitamin K antagonist (VKA)

Interventions

06

What researchers measure

Primary outcomes

  1. Stroke or systemic embolism (SSE)

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  2. 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 outcomes

  1. Hemorrhagic stroke

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  2. Ischemic stroke

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  3. Subtypes of major bleeding

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  4. Major adverse cardiovascular events (MACEs) and major adverse limb events (MALEs)

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  5. Acute kidney injury

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

  6. Renal impairment

    Time frame: Retrospective analysis from January 1, 2011 to December 31, 2017

07

Study locations

1 site
  • Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases
    Multiple Locations, Washington 20001, United States
08

References and documents

Publications

  • Coleman CI, Kreutz R, Sood N, Bunz TJ, Meinecke AK, Eriksson D, Baker WL. Rivaroxaban's Impact on Renal Decline in Patients With Nonvalvular Atrial Fibrillation: A US MarketScan Claims Database Analysis. Clin Appl Thromb Hemost. 2019 Jan-Dec;25:1076029619868535. doi: 10.1177/1076029619868535. PubMed 31392894 ↗
  • Martinez BK, Baker WL, Sood NA, Bunz TJ, Meinecke AK, Eriksson D, Coleman CI. Influence of Polypharmacy on the Effectiveness and Safety of Rivaroxaban Versus Warfarin in Patients With Nonvalvular Atrial Fibrillation. Pharmacotherapy. 2019 Feb;39(2):196-203. doi: 10.1002/phar.2213. Epub 2019 Jan 28. PubMed 30597611 ↗
  • Baker WL, Beyer-Westendorf J, Bunz TJ, Eriksson D, Meinecke AK, Sood NA, Coleman CI. Effectiveness and safety of rivaroxaban and warfarin for prevention of major adverse cardiovascular or limb events in patients with non-valvular atrial fibrillation and type 2 diabetes. Diabetes Obes Metab. 2019 Sep;21(9):2107-2114. doi: 10.1111/dom.13787. Epub 2019 Jun 11. PubMed 31099460 ↗
  • Hernandez AV, Bradley G, Khan M, Fratoni A, Gasparini A, Roman YM, Bunz TJ, Eriksson D, Meinecke AK, Coleman CI. Rivaroxaban vs. warfarin and renal outcomes in non-valvular atrial fibrillation patients with diabetes. Eur Heart J Qual Care Clin Outcomes. 2020 Oct 1;6(4):301-307. doi: 10.1093/ehjqcco/qcz047. PubMed 31432074 ↗
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2017 to primary completion in Aug 2019, 20 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2017
First posted
Dec 15, 2017
StartActual
Dec 1, 2017
Primary completionActual
Aug 30, 2019
CompletionActual
Aug 30, 2019
Last update
Aug 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03374540
Lead sponsor
Bayer
Responsible party
Sponsor
First posted
Dec 15, 2017
Start date
Dec 1, 2017
Primary completion
Aug 30, 2019
Completion
Aug 30, 2019
Last update
Aug 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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