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Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease

NCT03969953 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1753

Last updated 2026-03-23

No results posted yet for this study

Summary

The TRACK trial is an investigator-initiated, multicentre, prospective, randomised, quadruple-blind (participant, healthcare provider, data collector, outcomes assessor), placebo-controlled trial. TRACK is a global trial and will be conducted in renal units that provide comprehensive CKD care. Approximately 2000 participants will be recruited.

The TRACK trial will assess a strategy of administering low dose rivaroxaban to reduce the risk of major adverse cardiac event (MACE) in people with Chronic Kidney Disease (CKD) stages 4 or 5 or dialysis-dependent kidney failure, and elevated cardiovascular (CV) risk (marked by a history of CAD or PAD, or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age ≥65 years).

Conditions

Interventions

DRUG

Rivaroxaban 2.5 Mg Oral Tablet

Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

OTHER

Placebo

Rivaroxaban matched placebo

Sponsors & Collaborators

  • Emerald Clinical Inc.

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • Central Hospital, Nancy, France

    collaborator OTHER

  • King Abdullah International Medical Research Center

    collaborator OTHER

  • The George Institute

    lead OTHER

Principal Investigators

  • Sunil Badve · The George Institute

  • Martin Gallagher · The George Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2025-10-30
Completion
2025-10-30

Countries

  • Australia
  • Belgium
  • Canada
  • France
  • Germany
  • India
  • Malaysia
  • Nepal
  • Saudi Arabia
  • Singapore
  • Taiwan
  • Tunisia

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT03969953 on ClinicalTrials.gov