Issue 7 |  21 December 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.

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

Below figures are as of 20 Dec 2021. Only sites with participants on run-in or randomised have been included.

Important Study Updates

1. Two hospitalisations for the same event
In the situation whereby a participant has had a Serious Adverse Event (SAE) which resulted in two (2) separate hospitalisations, these 2 hospitalisations should be reported in 2 SAE forms.

For example, a patient has an infection requiring hospitalisation on 24th May. The patient is discharged, but 6 days later is admitted to hospital again for the same diagnosis. Both the initial hospitalisation on 24th May and subsequent hospitalisation on 30th May should be reported.

2. Outcome & Serious Adverse Events (SAE) that result in death
If a participant has had an Outcome event and passes away as a result, 2 outcome forms should be completed - one for the initial outcome and one for the death. Similarly, if the participant has had an SAE and passes away, both the SAE form and the Outcome form (for the death) should be completed.

Example 1: A participant has a stroke and dies 2 weeks later. The stroke should be entered in the Outcome form and the subsequent death on a separate Outcome form.

Example 2: A participant is hospitalised for COVID and the event status on the SAE form is ‘Ongoing’. If the participants later dies, the event status on SAE form should be changed to ‘Fatal’ & an Outcome form for the death should be completed.

3. COVID vaccination data entry
When a participant receives a COVID vaccine (whether their first dose, second dose, or booster shot), this should be entered into the Concomitant Medications page in the eCRF.

4. Participants who have discontinued study drug
If a participant for any reason will no longer continue taking study drug, please aim to ensure that the participant remains in the trial as part of follow-up.
Timelines for follow-up visits, calls, and data entry should adhere to the usual study visit windows.

Study Procedures Video

The latest training video 'Study Procedures' has been uploaded to both the TRACK trial website and the TRACK Youtube playlist.

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.