CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,753 enrolled
Drug / intervention
Rivaroxaban 2.5 Mg Oral Tablet +1 moredrug
Likely dose
Rivaroxaban 2.5 Mg Oral Tabletfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03969953
NCT03969953Phase 3Completed

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

The George Institute·interventional·Posted May 31, 2019·Updated Mar 23, 2026

In Brief

A Phase 3 clinical trial evaluating Rivaroxaban 2.5 Mg Oral Tablet and Placebo for Chronic Kidney Diseases and 2 related conditions. Completed, enrolled 1,753 participants across 88 sites in 12 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Belgium, Canada, France, Germany, India, Malaysia, Nepal, Saudi Arabia, Singapore, Taiwan, Tunisia

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedMay 31, 2019
Enrollment StartJan 18, 2021
Primary CompletionOct 30, 2025
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 7.1 years ago

Interventions

Rivaroxaban 2.5 Mg Oral Tabletdrug

Rivaroxaban is an orally administered selective direct factor Xa inhibitor.

Placeboother

Rivaroxaban matched placebo