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.
TRACK Global Steering Committee Meeting
7.30pm (AEDT) | 2nd March 2022
Figures are as of
28 Feb 2022. Only sites with participants on run-in or
randomised have been included.
Important Study Updates
1. Tranche 1 On-Study
Drug - Last Dispense Date
The
last date of dispense for Tranche 1 on-study/maintenance
drug (expiry of 1st September 2022) has been pushed further back
to 1st of March 2022. This is to accommodate for the last few
sites yet to receive Tranche 2 study drug.
A reminder to sites to please monitor participants who are
dispensed Tranche 1 maintenance bottles in February 2022
and ensure that these participants return for their subsequent
dispense visit within 6 months.
2. Life-Threatening
Assessment for SAEs/Outcomes
When
reporting on SAEs and Outcomes in TRACK IBM database, please be
mindful of the classification of 'Life-Threatening':
Life-Threatening in the definition of a Serious Adverse Event or
Serious Adverse Reaction refers to an event in which the participant
was at risk of death at the time of the event.
3. Rivaroxaban
IB v29.0
The
latest version of the Rivaroxaban Investigator's Brochure (version
29.0) has been released. This latest version includes updated
information from on-going studies. Please note that there are no change to the risk/benefit assessment.
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.
