Comparing two anticoagulant treatment, Warfarin (Standard treatment) and Apixaban (A new treatment) in patients with a Mechanical Heart for bleeding and thrombosis complications.

Comparing Standard of Care Versus Apixaban in patients with a Ventricular Assist Device: a Parallel, randomised, non-inferiority, open label, control, pilot-study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12621000956808

Acronym

ApixiVAD

Enrollment

Registered

2021-07-21

Start date

2022-01-12

Completion date

2024-02-01

Last updated

2023-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We aim to investigate whether anticoagulation with apixaban 2.5mg BD is as safe as warfarin in patients implanted with a Ventricular Assist Device (VAD). Our hypothesis is that when used in combination with an antiplatelet agent (such as aspirin 100mg daily), apixaban is not inferior to warfarin for the prevention of thrombosis formation in patients who have had a VAD implanted for a minimum of 2 months and without any bleeding or thrombotic complications during the period between 2 months post VAD implantation

Interventions

The intervention is the administration of apixaban, an oral tablet dosed at 2.5mg twice a day, in combination with an antiplatelet agent such as aspirin 100mg daily. Patient receiving this intervention will remain on it until heart transplantation or until the end of the study (maximum of 24 months following randomisation). Adherence to the intervention will be monitored with trough anti-Xa levels at baseline and then at a primary endpoint.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

Inclusion criteria

Patients implanted with a Left Ventricular Assist Device (LVAD) and fulfilling the following (inclusion) criteria: - Patients implanted with a ventricular assist device in the left ventricle - Patients actively following up in the mechanical circulatory support clinic at St. Vincent’s Hospital, Sydney - Bodyweight greater than 60 Kg - Patients aged between 18 and 70 years - Creatinine clearance greater than 25ml/min and creatinine level < 221mcmol/l - Participant able to give an informed consent - TTR in the preceding 4 weeks of 60% or more - Reason for VAD implantation is either as a bridge to decision (BTD) or a bridge to transplant (BTT)

Exclusion criteria

- Stroke following VAD implantation (if occurred more than 4 weeks after VAD implantation) - Major bleeding (if occurred more than 4 weeks after VAD implantation) - Requirement for treatment with aspirin at a dose greater than 100 mg per day - Simultaneous treatment with both aspirin and a thienopyridine (e.g., clopidogrel, prasugrel, ticagrelor) - Women who are pregnant or breastfeeding - Allergy to apixaban - TTR <60% in the preceding 4 weeks - Severe renal insufficiency (serum creatinine > 221mcmol/l or a calculated creatinine clearance < 25 mL/min) - Alanine transaminase > 5x ULN or known cirrhotic liver disease - Active alcohol or illicit drug use, or psychosocial reasons that make study participation impractical - Patients with known Human Immunodeficiency Virus (HIV) infection - Patients taking medications or other substances known to be potent inhibitors of the CYP3A4 enzyme (e.g. -azole antifungals (itraconazole and ketoconazole), macrolide antibiotics (clarithromycin and telithromycin), protease inhibitors (ritonavir, indinavir, nelfinavir, atazanavir, and saquinavir), and nefazadone) - Patient taking medications or substances known to be potent inducers of the CAP3A4 enzyme (e.g. antituberculosis treatments (rifampicin)) - Allergy to any of component ingredients of Andexanet-alfa: tris, arginine, sucrose, hydrochloric acid, mannitol, and polysorbate 80 (if available).

Outcome results