Phase 2
N=30
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT04865978 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
Nov 2024
Primary outcome: Primary: Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) — 16; 12 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Apixaban (Drug); Warfarin (Drug); LVAD implant (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Palak Shah
- Primary completion
- Oct 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) |
16; 12 | — |
| SECONDARY Survival Free of Any Stroke |
16; 14 | — |
| SECONDARY Survival Free of Ischemic Stroke |
16; 14 | — |
| SECONDARY Survival Free of Hemorrhagic Stroke |
16; 14 | — |
| SECONDARY Survival Free of Device Thrombosis |
16; 14 | — |
| SECONDARY Survival Free of Gastrointestinal Bleeding |
16; 12 | — |
| SECONDARY Survival Free of Major Non-gastrointestinal Bleeding |
16; 14 | — |
| SECONDARY All-cause Mortality |
0; 0 | — |
| SECONDARY Cardiovascular Mortality |
0; 0 | — |
| SECONDARY Survival Free of Aortic Root Thrombus |
16; 14 | — |
Summary
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
Eligibility Criteria
Inclusion Criteria
- 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 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
- 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 ( 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 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
Data sourced from ClinicalTrials.gov (NCT04865978). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.