← Back to all trials
Recruiting
NCT05410275
Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients
Conditions: Chronic Hemodialysis Patients
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 10
Sponsor: University Hospital, Tours
Location: 01-Arauco Tours
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 \
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Any indication for long-term oral anticoagulation (atrial fibrillation, venous thromboembolic disease, mechanical valve prostheses, intracardiac thrombosis, etc.)
* Double anti-platelet aggregation for any reason or an aspirin dose greater than 160 mg/day
* Uncontrolled hypertension (BP \> 180/110 mmHg)
* Ischemic stroke within 30 days prior to inclusion
* History of major unprovoked hemorrhage (leading to hospitalization or transfusion) regardless of age
* Surgery within 30 days prior to inclusion
* High-risk bleeding condition in addition to renal failure (such as known coagulation disorder, thrombocytopenia (\< 100G/L), active neoplasia of the digestive or urinary tract, or presence of intracranial vascular malformation)
* Severe hepatic impairment
* Use of strong CYP3A4 inducers, including rifampin, St. John's Wort, carbamazepine, phenytoin, phenobarbital
* Non-compliant patients
* Pregnant or breastfeeding women, women of childbearing age without effective contraception
* Contraindication to the administration of an anticoagulant treatment such as anti-phospholipid antibody syndrome
* Known allergy to rivaroxaban or to one of its excipients (lactose monohydrate)
* Patients under guardianship or conservatorship
* Patients already participating in an ongoing study or who have participated in a study that ended less than 30 days prior to the inclusion date.
Source: ClinicalTrials.gov (NCT05410275). StuddyBuddy aggregates publicly available trial information.