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Heart FailurePhase 2DOAC LVADNCT04865978

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

A Phase 2 study testing Apixaban, Warfarin and LVAD implant in people with Heart Failure, run by Palak Shah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin. Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Heart Failure
What is being tested?
Apixaban, Warfarin and LVAD implant
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
14 Dec 2021to 7 Nov 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Inova Fairfax Medical Campus

    Falls Church, Virginia, 22042

Other trials in United States

About this study

Prospective, randomized, controlled, open label, trial of LVAD patients with 1:1 randomization to either apixaban or warfarin.

Read the 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).

Conditions
Heart Failure
Being tested
Apixaban, Warfarin, LVAD implant
Keywords
ventricular assist device, LVAD, anticoagulation, apixaban, warfarin
Medical subject headings
Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Patients randomized to apixaban will be started on a dose of 5 mg BID.

  • WarfarinDrug

    Patients randomized to warfarin will be started on a dose per institutional protocol and titrated to an INR goal of 2.0 - 2.5.

  • LVAD implantDevice

    Subjects will undergo HeartMate 3 LVAD implant prior to randomization

Study groups in NCT04865978
Study groupRoleWhat they receive
ApixabanExperimentalLVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.
Receives: Drug: Apixaban; Device: LVAD implant
WarfarinActive comparatorLVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5
Receives: Drug: Warfarin; Device: LVAD implant

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Freedom From Death or Hemocompatibility Related Adverse Events (Stroke, Device Thrombosis, Bleeding, Aortic Root Thrombus, and Arterial Non-CNS Thromboembolism)

    Freedom from death or hemocompatibility related adverse events (composite of stroke, device thrombosis, bleeding, aortic root thrombus, and arterial non-CNS thromboembolism)

    Measured: From enrollment to end of treatment at 24 weeks

Secondary outcomes (9)

  1. Survival Free of Any Stroke

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  2. Survival Free of Ischemic Stroke

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  3. Survival Free of Hemorrhagic Stroke

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  4. Survival Free of Device Thrombosis

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  5. Survival Free of Gastrointestinal Bleeding

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  6. Survival Free of Major Non-gastrointestinal Bleeding

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  7. All-cause Mortality

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  8. Cardiovascular Mortality

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

  9. Survival Free of Aortic Root Thrombus

    Compared between each study arm

    Measured: From enrollment to end of treatment at 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2021
  2. Study start14 Dec 2021
  3. Primary completion5 Oct 2023
  4. Study completion7 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Open-label, prospective, randomized, 1:1 intervention arm versus control
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04865978
Sponsor's protocol ID
U21-06-4470
Acronym
DOAC LVAD
Status last verified
Oct 2024
First submitted
26 Apr 2021
Last updated
14 Nov 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Dimond M, Looby M, Shah B, Sinha SS, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, O'connor CM, Shah P. Design and Rationale for the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices (DOAC LVAD) Study. J Card Fail. 2024 Jun;30(6):819-828. doi: 10.1016/j.cardfail.2023.10.473. Epub 2023 Nov 11.

    PubMed 37956897

  • Shah P, Looby M, Dimond M, Bagchi P, Shah B, Isseh I, Rollins AT, Abdul-Aziz AA, Kennedy J, Tang DG, Klein KM, Casselman S, Vermeulen C, Sheaffer W, Snipes M, Sinha SS, O'Connor CM. Evaluation of the Hemocompatibility of the Direct Oral Anticoagulant Apixaban in Left Ventricular Assist Devices: The DOAC LVAD Study. JACC Heart Fail. 2024 Sep;12(9):1540-1549. doi: 10.1016/j.jchf.2024.04.013. Epub 2024 May 7.

    PubMed 38795110

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Apixaban, Warfarin and LVAD implant in people with Heart Failure, run by Palak Shah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04865978, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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