check_circleStudy 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
  • - 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)


  • - <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
No
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Truven Health MarketScan Commercial Claims and Medicare Supplemental DatabasesMany locations, 20001, United States

Primary Outcome

  • Stroke or systemic embolism (SSE)
    date_rangeTime 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
    date_rangeTime Frame:
    Retrospective analysis from January 1, 2011 to December 31, 2017

Secondary Outcome

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