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Comparison of Bleeding Risk Between Rivaroxaban and Apixaban for the Treatment of Acute Venous Thromboembolism

NCT03266783 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2760

Last updated 2025-11-17

No results posted yet for this study

Summary

Apixaban and rivaroxaban have been compared to standard therapy for treatment of acute symptomatic venous thromboembolism (VTE) in randomized controlled trials (RCTs), and are both approved by Health Canada. No safety or efficacy data is available from direct head-to-head comparison of these two anticoagulants. Lawsuits in the United States over bleeding events, patient perceptions, and concerns with medication adherence are additional factors highlighting the importance of a comparison trial. This multi-center, pragmatic, prospective, randomized, open-label, blinded end-point (PROBE) trial aims to compare the safety of apixaban and rivaroxaban for the treatment of VTE.

Conditions

  • Venous Thromboembolism

Interventions

DRUG

Apixaban

Refer to Apixaban group

DRUG

Rivaroxaban

Refer to Rivaroxaban group

Sponsors & Collaborators

  • Canadian Venous Thromboembolism Clinical Trials and Outcomes Research (CanVECTOR) Network

    collaborator NETWORK

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Ottawa Hospital Research Institute

    lead OTHER

Principal Investigators

  • Lana Castellucci, MD, FRCPC · Ottawa Hospital Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-13
Primary Completion
2025-04-30
Completion
2025-09-08

Countries

  • Australia
  • Canada
  • Ireland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03266783 on ClinicalTrials.gov