Issue 5   |  25 Aug 2021 

 

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.

 

In this newsletter:

 

 

Recruitment and Country Updates


To remain up to date on site status, visit https://www.tracktrial.org/participating-sites/

Below figures are as of 23 Aug 2021. Only sites with participants on run-in or randomised have been included.

 

The participant recruitment rate in the past couple of months have decreased due to COVID-19 outbreaks and lock-downs around the world.

 

 

Important Study Updates

 

1. Reporting of bleeds

We wish to provide some feedback on the reporting of bleeds in TRACK IBM:

In the case of a bleeding event, follow the TRACK Protocol section 13.7 and investigate for the cause of bleeding. For example, if there is prolonged bleeding at the AV fistula site after haemodialysis, the cause of bleeding is likely to be stenosis at the AV anastomosis. 

Bleeding episodes that do not meet the criteria of major bleeding do not need to be reported as trial outcomes.

The above clarification will be included in the next protocol amendment.

 

2. COVID-19 vaccination

A quick reminder to all sites again on the importance of COVID-19 vaccinations. We encourage site staff to prioritise the recruitment of participants who have been vaccinated to ensure that the trial's statistical power is not reduced by COVID-19 deaths.

 

For any COVID-19 deaths, please enter into the Outcome form in the database as per below:

 

3. Participants who have stopped study medication

If a participant has stopped study medication either temporarily or permanently for any reason,:

  • SAE reporting continues even after the participant has stopped study medication. SAEs must be entered in the database from the time of consent to the last study visit for all participants.
     
  • They are allowed to resume taking study medication no matter how long it has been since they first stopped study medication (unless the study has ended).
     
  • The dates of their study medication stoppage and/or resumption must be entered into the Study Medication Log in the database.

 

IBM Training Database Passwords


The login for one of the Study Coordinator roles in the TRACK training database has been updated.
Reminder that upon signing in, please remember to untick the 'Show Live Studies' checkbox so that the 'TRACK Training' database can appear.

 

If you have any trouble logging in or are prompted to update the password upon sign-in, please e-mail [email protected] for assistance.


Please note that the TRACK IBM database (both training and live) will only allow five (5) login attempts prior to permanently locking the account. Therefore, if by the 4th attempt you are still unable to log in, please click the 'Need help logging in?' link located on the IBM Secure Login front page.

 

Journal Club


Below are some interesting recently published renal studies:
 

  1. The Risk of Acute Kidney Injury with Oral Anticoagulants in Elderly Adults with Atrial Fibrillation

A population-based cohort study involving 20,683 elderly patients from Ontario, Canada with atrial fibrillation who were prescribed warfarin, dabigatran, rivaroxaban or apixaban showed that each direct oral anticoagulant was associated with a significantly lower risk of acute kidney injury compared to warfarin (weighted HR 0.65; 95% CI 0.53 to 0.80 for dabigatran, weighted HR 0.85; 95% CI 0.73 to 0.98 for rivaroxaban; and weighted HR 0.81; 95% CI 0.72 to 0.93 for apixaban). In subgroup analysis, the lower risk of acute kidney injury associated with each direct oral anticoagulant was consistent across each eGFR strata, including those with eGFR <30 mL/min/1.73 m2.
Link: https://cjasn.asnjournals.org/content/early/2021/08/18/CJN.05920421.1

  1. Safety and Efficacy of Vitamin K Antagonists versus Rivaroxaban in Hemodialysis Patients with Atrial Fibrillation: A Multicenter Randomized Controlled Trial

Direct oral anticoagulants have a superior risk-benefit profile compared with vitamin K antagonists in patients with normal renal function or early stage CKD, but whether this can be extended to the hemodialysis population is unknown. In this manuscript, the authors report the first randomized controlled trial - the Valkyrie study - of thromboembolic and bleeding risk in patients on hemodialysis with atrial fibrillation on long-term treatment with a vitamin K antagonist or rivaroxaban. After a median follow-up of 1.88 years, the composite outcome of fatal and nonfatal cardiovascular events occurred more frequently in the vitamin K antagonist group than with rivaroxaban, as did major bleeding complications.
Link: https://jasn.asnjournals.org/content/32/6/1474

  1. Rivaroxaban in Patients With Recent Peripheral Artery Revascularization and Renal Impairment: The VOYAGER PAD Trial

In the VOYAGER PAD trial involving 6564 patients with peripheral artery disease, low dose rivaroxaban (2.5 mg twice daily) plus aspirin, reduced major cardiovascular and limb events compared with placebo (HR 0.85; 95% CI 0.76 to 0.96). A pre-specified subgroup analysis by kidney function showed that low dose rivaroxaban reduced primary endpoint events with no heterogeneity by eGFR category, suggesting that the efficacy of low dose rivaroxaban is preserved in people with CKD. Similarly, there was no heterogeneity for bleeding risk by eGFR category. No excess of intracerebral or fatal hemorrhage was observed with low dose rivaroxaban. Due to the greater event rates of major cardiovascular and limb events in patients with CKD, these patients derived a greater absolute benefit with low dose rivaroxaban. This CKD subgroup analysis strongly supports the equipoise of the TRACK trial.
Link: https://www.jacc.org/doi/full/10.1016/j.jacc.2021.06.021
 

 

 

TRACK Feature Profile

 

Name: Yulan Shen
Position: Renal Research Nurse
Location: Renal Service, Illawarra Shoalhaven Local Health District
About: Yulan moved to Australia as an international student in 2005 and commenced her renal career in 2006. She has an interest in clinical practice improvement from a local and national level. Her current role involves coodinating clinical researchers, managing data, and administrating all activities in renal research team.