NCT05410275: CARD-AXA

Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients

Status unknown Phase 3 Last updated 8 June 2022

What this trial tests

Phase 3 trial testing Rivaroxaban in Chronic Hemodialysis Patients in 10 participants. Status unknown.

Timeline

1 December 2022

Primary endpoint
1 December 2023

1 January 2024

Quick facts

Lead sponsor	University Hospital, Tours
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 December 2022
Primary completion	1 December 2023
Estimated completion	1 January 2024

Drugs / interventions tested

• Rivaroxaban (rivaroxaban) — full drug profile →

Conditions studied

• Chronic Hemodialysis Patients — all drugs for Chronic Hemodialysis Patients →

Sponsor

University Hospital, Tours

Who can join

18 and older, any sex, with Chronic Hemodialysis Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Atrial fibrillation is the most frequent cardiac rhythm disorder and its prognosis is essentially marked by the risk of embolic events. Its treatment is based on long-term oral anticoagulant therapy according to the risk of embolic events assessed by risk scores such as the CHA2DS2-Vasc score, but this prescription is associated with a risk of hemorrhagic events that must be taken into consideration when deciding on the treatment for a given patient. There are two categories of validated oral anticoagulant treatments for the prevention of embolic events in atrial fibrillation: antivitamin K agents, which have long been the reference treatment but are restrictive and difficult to use because of a narrow therapeutic window, and direct oral anticoagulants, which are now the first-line treatment but have not been evaluated in phase II and III studies in patients with severe renal failure. End-stage renal disease (clearance \<15 mL/min/1.73m2), particularly at the dialysis stage, is a risk factor for cardiovascular disease in its own right, and a significant number of patients develop atrial fibrillation. Given the co-morbidities associated with renal failure, in particular hypertension, patients with renal failure undergoing dialysis and suffering from atrial fibrillation are generally at a higher risk of embolism than patients without renal failure, but also at a higher risk of bleeding. Thus, if the indication for prescribing oral anticoagulant therapy is clear in this population, the associated bleeding complications are also more frequent and more serious in these patients who have regular vascular accesses in the context of hemodialysis. There is thus a real need for reliable therapeutic alternatives with a better benefit/risk ratio than antivitamins K.

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Publications & conference data

No peer-reviewed publications indexed yet for this trial.