DOAC LVAD: Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices

Sponsor
Palak Shah (Other)
Overall Status
Recruiting
CT.gov ID
NCT04865978
Collaborator
Abbott Medical Devices (Industry)
40
1
2
29
1.4

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

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Open-label, prospective, randomized, 1:1 intervention arm versus controlOpen-label, prospective, randomized, 1:1 intervention arm versus control
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices
Actual Study Start Date :
Dec 14, 2021
Anticipated Primary Completion Date :
Dec 14, 2023
Anticipated Study Completion Date :
May 14, 2024

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

  1. 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

  1. Survival free of any stroke [24 weeks]

    Compared between each study arm

  2. Survival free of ischemic stroke [24 weeks]

    Compared between each study arm

  3. Survival free of hemorrhagic stroke [24 weeks]

    Compared between each study arm

  4. Survival free of device thrombosis [24 weeks]

    Compared between each study arm

  5. Survival free of gastrointestinal bleeding [24 weeks]

    Compared between each study arm

  6. Survival free of major non-gastrointestinal bleeding [24 weeks]

    Compared between each study arm

  7. All-cause mortality [24 weeks]

    Compared between each study arm

  8. Cardiovascular mortality [24 weeks]

    Compared between each study arm

  9. Survival free of aortic root thrombus [24 weeks]

    Compared between each study arm

Other Outcome Measures

  1. 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

Ages Eligible for Study:
18 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patients implanted with a HeartMate 3 LVAD

  2. Age 18 or greater and able to provide written informed consent

  3. Females of childbearing age must agree to adequate contraception

Exclusion Criteria:
  1. History of post-LVAD device thrombosis, stroke, or gastrointestinal bleeding

  2. Patients who are bridge to transplant and a current UNOS status 1-3

  3. Ongoing inotrope therapy after LVAD (e.g., milrinone, dobutamine, epinephrine)

  4. Permanent right ventricular assist device at the time of LVAD implant

  5. Patients with a mechanical heart valve

  6. Patients with end-stage renal disease on dialysis

  7. Pregnant patients

  8. Known history of ischemic stroke, intracranial bleed, or neurosurgery within 3 months

  9. Known history of intracerebral arteriovenous malformation, cerebral aneurysm or mass lesions of the central nervous system.

  10. Recent (<48 hours) or planned spinal or epidural anesthesia or puncture

  11. 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.

  12. Thrombolysis within the previous 7 days

  13. Patients with an allergy or contraindication to aspirin, warfarin, or apixaban

  14. Patients on antiplatelet therapy other than aspirin (e.g., clopidogrel, prasugrel, ticagrelor, dipyridamole, or pentoxifylline)

  15. Patients on combined P-glycoprotein and strong CPY3A4 inhibitors or inducers (e.g., fluconazole, posaconazole, rifampin)

  16. Known bleeding within the last 30 days requiring emergency room presentation or hospitalization

  17. Known history of an inherited bleeding disorder (e.g., hemophilia, von Willebrand disease)

  18. Patients with active bleeding or a hemoglobin < 8.0 g/dl

  19. Total bilirubin > 2.0 mg/dl, shock liver, hepatic encephalopathy, or biopsy proven liver cirrhosis

  20. INR > 2.0 not due to anticoagulation therapy

  21. 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.
Responsible Party:
Palak Shah, Medical Director, Mechanical Circulatory Support, Inova Health Care Services
ClinicalTrials.gov Identifier:
NCT04865978
Other Study ID Numbers:
  • 00100
First Posted:
Apr 29, 2021
Last Update Posted:
Feb 23, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Palak Shah, Medical Director, Mechanical Circulatory Support, Inova Health Care Services
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2022