Issue 14   |  28 Feb 2023 


Study Overview
The TRACK trial will evaluate whether a small dose of rivaroxaban, a blood-thinning medication, would reduce cardiovascular death or major cardiovascular events in patients with advanced stages of chronic kidney disease.


Important Updates & Reminders


1. SAEs that are study outcomes

For the purpose of this trial, the following SAEs will be captured on the eCRF as study outcome events only and will be exempted from expedited reporting to the Sponsor. These events are to be reported on the eCRF within seven days after discharge (or separation) from hospital. 

• Primary efficacy outcomes
- cardiovascular death
- non-fatal myocardial infarction
- stroke
- peripheral artery disease event

• Secondary and tertiary efficacy outcomes
- all-cause death (including non-cardiovascular death and death due to undetermined cause)
- venous thromboembolism
- thrombosis of dialysis vascular access among participants with an AV fistula/graft

• Safety outcomes
- Modified ISTH major bleeding events, including fatal bleeding, symptomatic bleeding in a critical area or organ, or bleeding leading to hospitalisation
- Gastrointestinal bleeding

Due to the expected nature of these events in the study population, study outcomes will not be considered to be SUSARs for regulatory reporting purposes.


2. Bleeding Events Overview - DSMB Report December 2022

The TRACK DSMB report from December 2022 shows that bleeding rates in the study have so far been lower than compared to bleeding rates in the overall population and what has been described in literature. It is most likely due to excluding patients at high risk of bleeding from the study.


Table 8: Bleeding events overview
Image from TRACK Blinded Report #3_01Dec2022 presented on the DSMB Meeting of 8 December 2022.


Q&A with Dr Brendan Smyth


Dr Brendan Smyth is the TRACK Site Principal Investigator at St George Hospital in Sydney NSW, one of the top recruiters sites in Australia. Dr Smyth has kindly agreed to participate in this Q&A session to share valuable information about how to address some of the recruitment barriers expressed by other Site Investigators during the Investigator Meetings held this year.


Q.1: “At my site, potential participants initially show interest in the trial, however, when they or their family read about the potential bleeding risks, they decline participation. How can we address these bleeding risks concerns with participants?”

A: When talking with potential participants and their families, I emphasise a few points to ensure that they have a proportionate understanding of the real risk involved. Firstly – and most importantly – I make it clear that although rivaroxaban is an anticoagulant, we are using a very low dose of this medication. It helps to be clear that this is not like going on warfarin or clopidogrel (which they may have heard of). I follow this up by reporting that the latest blinded Data and Safety Monitoring Board report has showed that the observed bleeding rate till date is actually lower than expected for patients with advanced CKD and kidney failure. Secondly, I find it useful to explain that clotting is part of the problem when people have heart attacks or strokes – and so, like with aspirin, we believe that a low dose of a blood thinner may shift the balance in the body enough to reduce the chance of a cardiovascular event, without much increased risk of bleeding – this is, after all, why we’re doing the study. Finally, we’re clear that the trial has been designed very carefully to ensure that patients who are at high risk for major bleeding are specifically excluded – so if the participant has any particular concern then I want to hear it – I don’t want to enrol them if they are going to be at higher than expected bleeding risk.

Q.2: “When discussing the trial, some participants do not perceive benefits in trial participation. In their understanding, this is a preventive treatment that will not cure their diseases. How to clearly explain the potential benefits for the participants?”

A: I find two approaches here:
1) Appeal to self-interest – I explain that it is a well-known fact that the survival rates for patients with advanced CKD and kidney failure are substantially lower than many commonly diagnosed cancers such as breast and colorectal cancers. Nearly 50 to 60% of these deaths are due to cardiovascular disease. Unfortunately, life-saving medications, including rivaroxaban, that improve cardiovascular survival are not approved for patients with advanced CKD and kidney failure as their safety-benefit profile has not been tested in trials in these patients. Being in the TRACK trial gives the patient direct access to a treatment that is shown to be beneficial in people without advanced CKD. Sure, they might get placebo – but why wouldn’t they want to have a 50% chance of access to a potentially useful treatment?
2) Appeal to altruism – the data that they provide will help us determine if this treatment is indeed beneficial. If it is, we will then be able to use it in many more people and make a real difference to others who are in the same position that them. Since the burden of cardiovascular disease is very high among patients with advanced CKD and kidney failure, 'prevention' of cardiovascular events should be the top priority.

Q.3: “Some participants have expressed concern that it is a placebo-controlled trial and if they receive the placebo that they will be at a disadvantage and therefore chose not to participate” How can we address participants concern regarding receiving placebo?”

A: It is important to tell potential participants that even if they receive a placebo, they will receive the standard treatment as well. Therefore, the placebo treatment is not inferior to the standard treatment, and they are not disadvantaged even if they receive a placebo. In fact, studies show that trial participants do better than non-trial participants – in part because they are being watched over by the trial team as well as their usual doctors. From a purely self-interested point of view, since placebo is not harmful and the study is pragmatically designed so as to be low burden to them, they may as well choose to gain a 50% chance of receiving a potentially useful treatment as the downside of ‘placebo’ is small.

 Q.4: “When discussing the study with my colleagues some have decline to refer any eligible participants because of concerns around increased bleeding risk. Is there any data available around perceived increased bleeding risk for participants in the study”

A: There is a wealth of data to support the low risks associated with low dose rivaroxaban. According to the latest DSMB (December 2022), the blinded major bleeding rate in the TRACK trial was 3.8 per 100 person-years. This is lower than that described in cohort studies (haemodialysis on antithrombotic treatment 6.7 per 100 person-years and peritoneal dialysis on antithrombotic treatment 5.7 per 100 person-years: Nephrol Dial Transplant 2021, 36:170-175), and trials involving therapeutic anticoagulation (RENAL-AF trial: apixaban 31.5 per 100 person-years and warfarin 25.5 per 100 person-years; Valkyrie trial: rivaroxaban 9 per 100 person-years and 22.7 warfarin per 100 person-years). 

Q.5: “The TRACK trial does not pay as much per participant as some of our commercial trials so sometimes there is a reluctance to enrol participants into the study” Why should we enrol into this trial over other trials?”

A: Although commercial trials pay a lot more than the TRACK trial, commercial trials are also labour-intensive with extensive data collection, extensive trial-specific investigations, and strict timelines for SAE reporting. In comparison, the TRACK trial is designed as a large simple trial (LST) with minimal data collection; full integration of study visits in routine clinic practice; no extra burden on patients, care-givers and investigators; no requirement for reporting SAEs within 24 hours (except SUSARs); and no designated trial-specific laboratory, radiological or cardiac investigations. The per-participant payment in TRACK is actually equivalent to commercial trials when adjusted for workload.


Recruitment and Country Updates
All figures are as of 23 February 2023.



To remain up to date on site status, visit
Only sites with participants on run-in or randomised have been included.



IBM Training Database Logins

For any site staff who wish to train/practice data entry for the study, please visit the TRACK Training IBM Database by logging in with any of the following updated training accounts.


TRACK Feature Profiles


Name: Jenny Landrigan
TRACK Global Senior Project Manager
 Sydney, Australia
Jenny has a Bachelor of Applied Science (Biomedical) and a Master of Community Health and a Graduate Certificate in Health Education.  She started her career in research in the lab and then moved into industry were she has worked as a Clinical Research Associate, Clinical Team Leader and Project Manager.  During her career she has worked for big Pharma and large and small CROs.  She has also spent some time in the public hospital and university sectors.   What she has enjoyed most to date is being part of a team that has bought new and innovative medicines to the general public.  During her time at the George she is looking forward to using her experience to work on large global real world studies.  In her spare time she likes to keep fit and loves seeing anything live, including theatre, musicals and sports.


Annie's Farewell


Our TRACK Senior Project Officer, Annie Gao, has left the study in the beginning of February. From everyone in the TRACK Global Project Team, we thank Annie for her hard work and dedication to the TRACK trial and wish her all the very best in her next career chapter.

Below is a photo of Annie as well as a message from Annie herself. 

Name: Annie Gao
Position/Role: Senior Project Officer

Location: Sydney, Australia
About: After working at The George Institute (TGI) for the past 7.5 years, it is time for me to say Goodbye. I moved across multiple streams and met many people not just here at TGI, but around the world through my involvement in global trials which has been a major highlight. My main tasks in TRACK as part of the Global Project Team have been to manage all aspects of the study medication, database management, and the creation of training videos and these study update newsletters. I have learnt a lot from working on TRACK and I wish the study and everyone involved the best of luck and hope to work with you again sometime in the future.