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RECRUITING
NCT05410275
PHASE3

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

Summary

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. Translated with www.DeepL.com/Translator (free version)

Official title: Chronic Anticoagulation in End-stage Renal Disease Patients: Pharmacokinetics and Pharmacodynamic of a Reduced Dose Regimen of Rivaroxaban

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-01-08

Completion Date

2027-01-30

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

DRUG

Rivaroxaban

Experimental group Each patient will receive successively over 3 distinct periods the 3 doses of rivaroxaban to be evaluated, i.e., 5 mg, 10 mg, and 15 mg as a single daily dose (once daily over 3 days for each dose).

Locations (2)

01-Arauco

Tours, France

02-TOURS

Tours, France