Clinical Trial Details
| Trial ID: | L1025 |
| Source ID: | NCT05410275 |
| Associated Drug: | Rivaroxaban |
| Title: | Chronic Anticoagulation With a Reduced Dose Regimen of Rivaroxaban in End-stage Renal Disease Patients |
| Acronym: | CARD-AXA |
| Status: | UNKNOWN |
| Study Results: | NO |
| Results: | |
| Conditions: | Chronic Hemodialysis Patients |
| Interventions: | DRUG: Rivaroxaban |
| Outcome Measures: | Primary: Pharmacodynamics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day), Plasma anti-Xa activity assessment (international unit per milliliter, IU/mL) on serial blood sampling at specified time points, 1 month|Pharmacokinetics of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day), Direct measurement of Rivaroxaban plasma level (nanogram per milliliter, ng/mL) on serial blood sampling at specified time points, 1 month | Secondary: Hemorrhagic risk assessment of 3 reduced dose regimen of rivaroxaban (5 mg/day, 10 mg/day, or 15 mg/day), Every bleeding event will be reported and classified according to the BARC classification, 1 month |
| Sponsor/Collaborators: | Sponsor: University Hospital, Tours |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE3 |
| Enrollment: | 10 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT |
| Start Date: | 2022-12-01 |
| Completion Date: | 2024-01-01 |
| Results First Posted: | |
| Last Update Posted: | 2022-06-08 |
| Locations: | |
| URL: | https://clinicaltrials.gov/show/NCT05410275 |
