Study of Apixaban in Patients Receiving Hemodiafiltration
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
Summary
Atrial fibrillation (AF) is a prevalent and serious disease in hemodialysis (HD) patients.
Untreated AF increases the risk of deaths related to cardiovascular events and multiplies the
risk of strokes by 5. Anticoagulation with warfarin significantly reduces the incidence of
ischemic strokes in the general population, has a long half-life, and a narrow therapeutic
index that requires periodic monitoring. In addition, warfarin treatment is a frequent cause
of hospital admission for iatrogenesis. In HD patients, the relationship between stroke
prevention benefit and bleeding risk is an unmet medical need. It should be noted that in
these patients the risk of bleeding is multiplied by 3 to 10 times compared to the general
population. The new direct-acting oral anticoagulants (NACOs), thrombin inhibitors
(dabigatran), and activated factor X inhibitors (rivaroxaban, apixaban, edoxaban), do not
require regular monitoring, but their plasma concentrations are altered with the
deterioration of the renal function. According to its technical data sheets, they do not
recommend its use in clinical practice for HD patients. However, the apixaban data sheet
includes the results of a pilot clinical trial in the African American population on HD,
suggesting that it is a safe anticoagulant drug.
The objective of this clinical trial is to evaluate the pharmacokinetics, pharmacodynamics,
and short-term safety (4 weeks) of apixaban in the Spanish population with non-valvular
atrial fibrillation and on hemodialysis.
Long-term safety will be assessed in the extension study: prospective cohort study of
patients included in the clinical trial. Therefore, this project is comprised of 2 clinical
studies (one clinical trial and one extension study) whose objective is to evaluate the
pharmacokinetics, pharmacodynamics, and short and long-term safety of apixaban in patients on
hemodialysis and with non-valvular atrial fibrillation (FANV).
The results of this project (clinical trial and extension study) will provide evidence on
whether apixaban may be the anticoagulant treatment of choice for this type of patient.