BridgeMD
New treatment option for Chronic Hemodialysis Patients
Official title Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients
ClinicalTrials.gov ID: NCT05410275
What this study is testing
What is Rivaroxaban?
Rivaroxaban is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for chronic hemodialysis patients.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Any indication for long-term oral anticoagulation (atrial fibrillation, venous thromboembolic disease, mechanical valve prostheses, intracardiac...
- 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
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tours, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tours, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.