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
St.Vincent Hospital
30 participants
Jan 12, 2022
Interventional
Conditions
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
Eligibility
Plain Language Summary
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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.
Locations(2)
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ACTRN12621000956808