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8110 Gatehouse Road, Falls Church, VA 22042

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

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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