Atrial Fibrillation Clinical Trials

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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patient ≥ 18 years of age,

• Chronic hemodialysis patient for at least 3 months,

• Affiliated or beneficiary of a social security plan,

• Having signed a written and informed consent.

Locations
Other Locations
France
01-Arauco
RECRUITING
Tours
02-TOURS
RECRUITING
Tours
Contact Information
Primary
Fabrice IVANES, MD-PhD
F.IVANES@chu-tours.fr
+33247473663
Backup
Estelle BOIVIN, MSc
e.boivin@chu-tours.fr
+33247474620
Time Frame
Start Date: 2025-01-08
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 10
Treatments
Experimental: Rivaroxaban
Rivaroxaban 5 mg daily, administered orally, during 3 consecutive days. After a wash-out period of 4 days, Rivaroxaban 10 mg daily, administered orally, during 3 consecutive days.~After a wash-out period of 4 days, Rivaroxaban 15 mg daily, administered orally, during 3 consecutive days.
Sponsors
Leads: University Hospital, Tours

This content was sourced from clinicaltrials.gov