DOAC LVAD: Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Study Details
Study Description
Brief Summary
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
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 with aspirin 81 mg daily as per the LVAD manufacturer instructions for use (IFU).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Apixaban LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily. |
Drug: Apixaban
Patients randomized to apixaban will be started on a dose of 5 mg BID.
Device: LVAD implant
Subjects will undergo HeartMate 3 LVAD implant prior to randomization
|
Active Comparator: Warfarin LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5 |
Drug: Warfarin
Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.
Device: LVAD implant
Subjects will undergo HeartMate 3 LVAD implant prior to randomization
|
Outcome Measures
Primary Outcome Measures
- Freedom from death or hemocompatibility related adverse events (stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism) [24 weeks]
Composite endpoint in each arm
Secondary Outcome Measures
- Survival free of any stroke [24 weeks]
Compared between each study arm
- Survival free of ischemic stroke [24 weeks]
Compared between each study arm
- Survival free of hemorrhagic stroke [24 weeks]
Compared between each study arm
- Survival free of device thrombosis [24 weeks]
Compared between each study arm
- Survival free of gastrointestinal bleeding [24 weeks]
Compared between each study arm
- Survival free of major non-gastrointestinal bleeding [24 weeks]
Compared between each study arm
- All-cause mortality [24 weeks]
Compared between each study arm
- Cardiovascular mortality [24 weeks]
Compared between each study arm
- Survival free of aortic root thrombus [24 weeks]
Compared between each study arm
Other Outcome Measures
- The rate of primary and secondary outcomes will be evaluated in subgroups of patients within 3 months of implant versus greater than 3 months from LVAD implant [24 weeks]
Compared between each study arm
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients implanted with a HeartMate 3 LVAD
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Age 18 or greater and able to provide written informed consent
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Females of childbearing age must agree to adequate contraception
Exclusion Criteria:
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History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding
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Patients who are bridge to transplant and a current UNOS status 1-3
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Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine)
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Permanent right ventricular assist device at the time of LVAD implant
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Patients with a mechanical heart valve
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Patients with end-stage renal disease on dialysis
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Pregnant patients
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Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months
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Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system.
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Recent (<48 hours) or planned spinal or epidural anesthesia or puncture
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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.
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Thrombolysis within the previous 7 days
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Patients with an allergy or contraindication to aspirin, warfarin, or apixaban
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Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)
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Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)
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Known bleeding within the last 30 days requiring emergency room presentation or hospitalization
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Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)
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Patients with active bleeding or a hemoglobin < 8.0 g/dl
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Total bilirubin > 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis
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INR > 2.0 not due to anticoagulation therapy
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Platelet count <100,000 cells/mm3
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Inova Fairfax Medical Campus | Falls Church | Virginia | United States | 22042 |
Sponsors and Collaborators
- Palak Shah
- Abbott Medical Devices
Investigators
- Principal Investigator: Palak Shah, MD, MS, Inova Health Care Services
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 00100