Low Dose Rivaroxaban for Cardiovascular Disease
(TRACK Trial)
Trial Summary
What is the purpose of this trial?
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).
Will I have to stop taking my current medications?
The trial does not specify if you must stop all current medications, but you cannot participate if you are taking certain medications like P2Y12 inhibitors or phosphodiesterase inhibitors and do not wish to stop them. It's best to discuss your current medications with the trial team.
What data supports the effectiveness of the drug Rivaroxaban for cardiovascular disease?
Research shows that Rivaroxaban, when combined with aspirin, leads to better outcomes in preventing recurrent cardiovascular disease compared to aspirin alone. Additionally, Rivaroxaban has been effective in reducing thrombotic cardiovascular events and mortality in patients with a recent acute coronary syndrome.12345
Is low dose Rivaroxaban generally safe for humans?
Rivaroxaban (also known as Xarelto) has been shown to be generally safe in various studies for conditions like preventing blood clots after surgery and treating deep vein thrombosis. However, in high-risk patients with antiphospholipid syndrome, it was associated with more adverse events compared to warfarin, indicating that safety can vary depending on the specific condition and patient group.23678
How does the drug Rivaroxaban differ from other treatments for cardiovascular disease?
Rivaroxaban is unique because it is a direct inhibitor of factor Xa, which helps prevent blood clots, and it is taken orally with high bioavailability, meaning the body can use it effectively. Unlike some other anticoagulants, it does not require routine blood monitoring and has a low risk of interacting with other drugs.2491011
Research Team
Sunil Badve
Principal Investigator
The George Institute
Martin Gallagher
Principal Investigator
The George Institute
Eligibility Criteria
This trial is for people aged 65 or older with advanced chronic kidney disease (stages 4 or 5) or on dialysis, and who also have a high risk of heart problems due to conditions like diabetes, previous strokes, or being over the age of 65. Participants must not have uncontrolled high blood pressure, recent major bleeding, certain heart valve issues, severe liver disease, very low blood counts, be pregnant/breastfeeding in some regions, among other exclusions.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive low dose rivaroxaban or placebo to assess the reduction in risk of major adverse cardiac events
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Rivaroxaban (Anticoagulant)
Find a Clinic Near You
Who Is Running the Clinical Trial?
The George Institute
Lead Sponsor
Central Hospital, Nancy, France
Collaborator
George Clinical Pty Ltd
Industry Sponsor
Bayer
Industry Sponsor
Centre Hospitalier Régional Universitaire de Nancy
Collaborator
King Abdullah International Medical Research Center
Collaborator