Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03969953
Status:
RECRUITING
Last Update Posted:
2023-11-28
First Post:
2019-05-27
Brief Title:
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Sponsor:
The George Institute
Organization:
The George Institute
Study Overview
Official Title:
Treatment of Cardiovascular Disease With Low Dose Rivaroxaban in Advanced Chronic Kidney Disease
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TRACK
Brief Summary:
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
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
Detailed Description:
Background and Rationale Chronic Kidney Disease CKD is a major international health burden Despite the unacceptably high burden of cardiovascular disease CVD and associated mortality trial-data on the management of CVD in people with advanced stages of CKD and dialysis-dependent kidney failure are sparse Risk of bleeding in CKD and dialysis-dependent kidney failure is increased when compared to the general population Anticoagulant agents such as rivaroxaban are a core intervention in the prevention of CVD in the general population Nevertheless to mitigate trial risks 90 of the trials evaluating this form of intervention exclude these patient populations
The TRACK trial will evaluate the effect of low dose rivaroxaban in patients with CKD dialysis-dependent kidney failure Other trials have demonstrated that rivaroxaban reduces the risk of major cardio-vascular outcomes in high risk patients and the limited data showed that CKD status did not significantly affect this result
Hypothesis Compared to placebo low dose rivaroxaban reduces the risk of major adverse cardiac event MACE in people with 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
Objectives The primary objective is to determine whether low dose rivaroxaban compared to placebo significantly reduces the risk of a composite outcome of
CV death
non-fatal myocardial infarction
stroke or
peripheral artery disease PAD events
in people with CKD stages 4 or 5 or dialysis-dependent kidney failure and an elevated CV risk marked by a history of CAD or PAD or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age 65 years
A full list of secondary objectives are detailed in the protocol and include identifying risk reduction in the treatment group and whether this treatment is cost effective
Methodology The TRACK trial is an investigator-initiated multicentre prospective randomised quadruple-blind participant healthcare provider data collector outcomes assessor placebo-controlled trial The trial will test for the superiority of the trial intervention using a 11 allocation to parallel trial groups on the basis of a pre-specified number of primary outcomes events
This 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 evaluate the effect of low dose rivaroxaban in patients with CKD dialysis-dependent kidney failure Other trials have demonstrated that rivaroxaban reduces the risk of major cardio-vascular outcomes in high risk patients and the limited data showed that CKD status did not significantly affect this result
Hypothesis Compared to placebo low dose rivaroxaban reduces the risk of major adverse cardiac event MACE in people with 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
Objectives The primary objective is to determine whether low dose rivaroxaban compared to placebo significantly reduces the risk of a composite outcome of
CV death
non-fatal myocardial infarction
stroke or
peripheral artery disease PAD events
in people with CKD stages 4 or 5 or dialysis-dependent kidney failure and an elevated CV risk marked by a history of CAD or PAD or non-haemorrhagic non-lacunar stroke OR diabetes mellitus OR age 65 years
A full list of secondary objectives are detailed in the protocol and include identifying risk reduction in the treatment group and whether this treatment is cost effective
Methodology The TRACK trial is an investigator-initiated multicentre prospective randomised quadruple-blind participant healthcare provider data collector outcomes assessor placebo-controlled trial The trial will test for the superiority of the trial intervention using a 11 allocation to parallel trial groups on the basis of a pre-specified number of primary outcomes events
This is a global trial and will be conducted in renal units that provide comprehensive CKD care Approximately 2000 participants will be recruited
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None