Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease (NCT03969953) | Clinical Trial Compass
CompletedPhase 3
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Australia1,753 participantsStarted 2021-01-18
Plain-language 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).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥18 years,
✓. Kidney Failure on haemodialysis or peritoneal dialysis, or CKD stage 4 or 5 (eGFR ≤29 mL/min/1.73 m2) not receiving renal replacement therapy,
✓. Elevated cardiovascular risk, defined by at least one of the following:
✓. History of Coronary Artery Disease (CAD) or PAD or non-haemorrhagic non-lacunar stroke, or
✓. Diabetes mellitus, or
✓. Age ≥65 years.
Exclusion criteria
✕. Mechanical/prosthetic heart valve (does not include bioprosthetic valves that do not require therapeutic anticoagulation),
✕. Indication for, or contraindication to, anticoagulant therapy,
✕. High bleeding risk including any coagulopathy,
✕. Lesion or condition considered to be a significant risk of major bleeding,
✕. Major bleeding episode in the 30 days prior to study enrolment, or any active and clinically significant bleeding,
✕. Current treatment with P2Y12 inhibitors/adenosine diphosphate (ADP) receptor inhibitors (clopidogrel, prasugrel, ticagrelor, cangrelor) or phosphodiesterase inhibitors (dipyridamole), where the treating physician or patient does not wish to stop these medications,
✕. Concurrent treatment with strong inhibitors of combined CYP3A4 and P-glycoprotein; or strong inducers of CYP3A4,
✕. Any stroke within 1 month prior to enrolment,