RecruitingPhase 4ACTRN12621000956808

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


Sponsor

St.Vincent Hospital

Enrollment

30 participants

Start Date

Jan 12, 2022

Study Type

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

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Plain Language Summary

Simplified for easier understanding

This study is comparing two blood-thinning medications in patients who have a ventricular assist device (VAD) implanted — a mechanical pump used to help a failing heart circulate blood, often as a bridge to heart transplant. Warfarin has been the standard anticoagulant for VAD patients for decades, but it requires frequent blood tests and dose adjustments. Apixaban (Eliquis) is a newer anticoagulant that does not require regular monitoring and is more predictable. Researchers want to know if apixaban 2.5 mg twice daily is as safe as warfarin at preventing blood clots and dangerous bleeds in this setting. Participants at St. Vincent's Hospital Sydney who are at least 2 months post-VAD implant with no recent bleeding or clotting events will be randomly assigned to either apixaban or warfarin. Both groups will also take aspirin 100 mg daily. Outcomes including bleeding, stroke, pump thrombosis, and survival will be closely tracked. To be eligible, you must be aged 18 to 70, have a left-sided VAD, weigh more than 60 kg, have adequate kidney function, and have had stable anticoagulation control (good INR time in range) in the preceding month. Patients with a recent stroke, major bleed, HIV, or on certain interacting medications are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 interven

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)

St Vincent's Hospital (Darlinghurst) - Darlinghurst

NSW, Australia

Bern, Switzerland

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ACTRN12621000956808


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