Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
This pilot study will be a prospective, randomized, controlled, open label, trial of HeartMate 3 (HM3) LVAD patients with 1:1 randomization to either apixaban or warfarin. All patients will be treated with aspirin 81 mg daily as per the LVAD manufacturer instructions for use (IFU).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
30
Patients randomized to apixaban will be started on a dose of 5 mg BID.
Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.
Subjects will undergo HeartMate 3 LVAD implant prior to randomization
Inova Fairfax Medical Campus
Falls Church, Virginia, United States
Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)
Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Any Stroke
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Ischemic Stroke
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Hemorrhagic Stroke
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Device Thrombosis
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Gastrointestinal Bleeding
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Major Non-gastrointestinal Bleeding
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
All-cause Mortality
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Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Cardiovascular Mortality
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks
Survival Free of Aortic Root Thrombus
Compared between each study arm
Time frame: From enrollment to end of treatment at 24 weeks