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

October 21, 2024 updated by: Palak Shah
Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Falls Church, Virginia, United States, 22042
        • Inova Fairfax Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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
Device: LVAD implant
Subjects will undergo HeartMate 3 LVAD implant prior to randomization
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)
Time Frame: From enrollment to end of treatment at 24 weeks
Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)
From enrollment to end of treatment at 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival Free of Any Stroke
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Ischemic Stroke
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Hemorrhagic Stroke
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Device Thrombosis
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Gastrointestinal Bleeding
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Major Non-gastrointestinal Bleeding
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
All-cause Mortality
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Cardiovascular Mortality
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks
Survival Free of Aortic Root Thrombus
Time Frame: From enrollment to end of treatment at 24 weeks
Compared between each study arm
From enrollment to end of treatment at 24 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom From Death or Hemocompatibility Related Adverse Events Evaluated in Subgroups of Patients Within 3 Months of Implant Versus Greater Than 3 Months From LVAD Implant
Time Frame: From enrollment to end of treatment at 24 weeks
Freedom From Death or Hemocompatibility Related Adverse Events (composite of Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism) evaluated in subgroups of patients within 3 months of implant versus greater than 3 months from LVAD implant
From enrollment to end of treatment at 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palak Shah

Collaborators

Abbott Medical Devices

Investigators

  • Principal Investigator: Palak Shah, MD, MS, Inova Health Care Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2021

Primary Completion (Actual)

October 5, 2023

Study Completion (Actual)

November 7, 2023

Study Registration Dates

First Submitted

April 26, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

April 29, 2021

Study Record Updates

Last Update Posted (Estimated)

November 14, 2024

Last Update Submitted That Met QC Criteria

October 21, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U21-06-4470

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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