General Information
Age Group
AdultsStatus
RecruitingProtocol 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