drugset / Trial / NCT03969953

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

NCT03969953

RandomizedParallel-groupQuadruple-blindTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Rivaroxaban Other / unclassified 2.5 mg Oral