Understanding how Apixaban works in patients on peritoneal dialysis with atrial fibrillation
Pharmacokinetics and Safety Profile of Apixaban in Patients With Peritoneal Dialysis
This study is trying to see how well Apixaban works and how safe it is for patients with atrial fibrillation who are on peritoneal dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Shatin) |
| Trial ID | NCT05532878 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the pharmacokinetics and safety profile of Apixaban in patients with atrial fibrillation who are undergoing peritoneal dialysis. Given the unique physiology of drug clearance in peritoneal dialysis compared to hemodialysis, the study seeks to fill the knowledge gap regarding the use of direct oral anticoagulants in this specific population. The study will include stable peritoneal dialysis patients with non-valvular atrial fibrillation and no significant residual renal function, while excluding those at increased risk of bleeding or with contraindications to anticoagulation. The findings could provide valuable insights into the management of atrial fibrillation in end-stage renal disease patients on peritoneal dialysis.
Who should consider this trial
Good fit: Ideal candidates for this study are stable peritoneal dialysis patients with non-valvular atrial fibrillation and no significant residual renal function.
Not a fit: Patients with an increased risk of bleeding or contraindications to anticoagulation will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and efficacy of anticoagulation therapy for patients with atrial fibrillation undergoing peritoneal dialysis.
How similar studies have performed: While studies on direct oral anticoagulants in hemodialysis populations have shown promise, this specific approach in peritoneal dialysis is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * stable PD patients with non-valvular AF and with no significant residual renal function Exclusion Criteria: * increased risk of bleeding and those with contraindications to anticoagulation such as history of gastrointestinal bleeding, dual anti-platelet therapy, active malignancy, recent trauma and stroke
Where this trial is running
Shatin
- Department of Medicine & Therapeutics, Prince of Wales Hospital — Shatin, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Winston WS Fung, MBBS — Prince of Wales Hospital
- Study coordinator: Winston WS Fung, MBBS
- Email: fws898@ha.org.hk
- Phone: 852-55699689
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.