NCT04952792: HEMOCIONA

Study of Apixaban in Patients Receiving Hemodiafiltration

Completed Phase 2 Last updated 21 September 2023

What this trial tests

Phase 2 trial testing Apixaban 2.5 milligram Oral Tablet in Atrial Fibrillation in 11 participants. Completed in 15 December 2022.

Timeline

20 May 2021

Primary endpoint
15 December 2022

15 December 2022

Quick facts

Lead sponsor	Hospital Universitari de Bellvitge
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	20 May 2021
Primary completion	15 December 2022
Estimated completion	15 December 2022
Sites	1 location across Spain

Drugs / interventions tested

• Apixaban 2.5 milligram Oral Tablet

Conditions studied

• Atrial Fibrillation — all drugs for Atrial Fibrillation →
• Hemodialysis Complication — all drugs for Hemodialysis Complication →

Sponsor

Hospital Universitari de Bellvitge

Who can join

18 and older, any sex, with Atrial Fibrillation or Hemodialysis Complication. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Exploring Apixaban Pharmacokinetics, Pharmacodynamics, and Safety in Hemodiafiltration Patients.
   Otero A, Rosselló-Palmer E, Codina S, Lloberas N, et al · · 2024 · cited 1× · PMID 39291199 · DOI 10.1016/j.ekir.2024.06.030