Status:
COMPLETED
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Lead Sponsor:
Palak Shah
Collaborating Sponsors:
Abbott Medical Devices
Conditions:
Heart Failure
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
Detailed Description
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...
Eligibility Criteria
Inclusion
- Patients implanted with a HeartMate 3 LVAD
- Age 18 or greater and able to provide written informed consent
- Females of childbearing age must agree to adequate contraception
Exclusion
- 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
- Pregnant patients
- 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.
- Recent (\<48 hours) or planned spinal or epidural anesthesia or puncture
- Prior history of known thrombophilia (e.g., factor V Leiden, prothrombin gene mutation, protein C or S deficiency, antithrombin 3 deficiency, hyperhomocysteinemia, antiphospholipid antibody syndrome) or indication for higher INR goal (\>2.5) with warfarin.
- Thrombolysis within the previous 7 days
- Patients with an allergy or contraindication to aspirin, warfarin, or apixaban
- Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)
- Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)
- Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
- Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)
- Patients with active bleeding or a hemoglobin \< 8.0 g/dl
- Total bilirubin \> 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis
- INR \> 2.0 not due to anticoagulation therapy
- Platelet count \<100,000 cells/mm3
Key Trial Info
Start Date :
December 14 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04865978
Start Date
December 14 2021
End Date
November 7 2023
Last Update
November 14 2024
Active Locations (1)
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1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042