Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05410275). StuddyBuddy aggregates publicly available trial information.