Evaluation of the hemocompataibility of the Direct Oral Anti-Coagulant apixaban in Left Ventricular Assist Devices (DOAC LVAD)

General Information Age Group Adults Status Recruiting Protocol Number U21-06-4470 Background Information This is a study to evaluate the safety of apixaban as compared to warfarin in LVAD patients. This study will be a prospective, randomized, controlled, open label trial of LVAD patients with a 1:1 randomization to either apixaban or warfarin. Offered At Inova Fairfax Hospital 3300 Gallows Road Falls Church, VA 22042 Principal Investigator Palak Shah, MD, MS Eligibility Information Patients implanted with a HM3 LVAD Age ≥ 18 years and able to provide written informed consent Females of childbearing age must agree to use adequate contraception Ineligibility Information Major Exclusion Criteria: History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding Patients who are bridge to transplant and a current UNOS status 1-3 Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine) Permanent right ventricular assist device at the time of LVAD implant Patients with a mechanical heart valve Patients with end-stage renal disease on dialysis Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system For additional information, please visit: https://clinicaltrials.gov/ct2/show/NCT04865978 Contact Information Contact Name Bhruga Shah, CRN Contact Phone 703-776-2828 Contact Email Send Email