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OpenTrials
Completed

NCT Number: NCT03374540

Rivaroxaban vs Warfarin for SPAF in Multi-morbid Patients

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.

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Key information

Conditions

NonValvular Atrial Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Truven Health MarketScan Commercial Claims and Medicare Supplemental Databases

Multiple Locations, Washington, 20001, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rivaroxaban (Xarelto, BAY59-7939)

Drug

15/20 mg

Vitamin K antagonist (VKA)

Drug

Individually adjusted dose

Primary outcomes

  1. Stroke or systemic embolism (SSE)

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

  2. Major bleeding

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

    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

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

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Janssen Research & Development, LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 15, 2017
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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