drugset / Trial / NCT03969953
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Phase 3
Completed
1753 enrolled
The George Institute
Bayer · collabCentral Hospital, Nancy, France · collabEmerald Clinical Inc. · collabKing Abdullah International Medical Research Center · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rivaroxaban | Other / unclassified | 2.5 mg | Oral |