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

Primary Purpose

Heart Failure

Status

Recruiting

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Apixaban

Warfarin

LVAD implant

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring ventricular assist device, LVAD, anticoagulation, apixaban, warfarin

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 (<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

Sites / Locations

Inova Fairfax Medical CampusRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

Warfarin

Arm Description

LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.

LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5

Outcomes

Primary Outcome Measures

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

Composite endpoint in each arm

Secondary Outcome Measures

Survival free of any stroke

Compared between each study arm

Survival free of ischemic stroke

Compared between each study arm

Survival free of hemorrhagic stroke

Compared between each study arm

Survival free of device thrombosis

Compared between each study arm

Survival free of gastrointestinal bleeding

Compared between each study arm

Survival free of major non-gastrointestinal bleeding

Compared between each study arm

All-cause mortality

Compared between each study arm

Cardiovascular mortality

Compared between each study arm

Survival free of aortic root thrombus

Compared between each study arm

Full Information

NCT ID

NCT04865978

First Posted

April 26, 2021

Last Updated

February 22, 2023

Sponsor

Palak Shah

Collaborators

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT04865978

Brief Title

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

Acronym

DOAC LVAD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 14, 2021 (Actual)

Primary Completion Date

June 14, 2024 (Anticipated)

Study Completion Date

November 14, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Palak Shah

Collaborators

Abbott Medical Devices

4. Oversight

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.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure

Keywords

ventricular assist device, LVAD, anticoagulation, apixaban, warfarin

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

Open-label, prospective, randomized, 1:1 intervention arm versus control

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Apixaban

Arm Type

Experimental

Arm Description

LVAD patients randomized to the experimental arm will be prescribed apixaban 5 mg twice daily.

Arm Title

Warfarin

Arm Type

Active Comparator

Arm Description

LVAD patients randomized to the control arm will be prescribed warfarin which will be dosed to achieve an INR goal of 2-2.5

Intervention Type

Drug

Intervention Name(s)

Apixaban

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Warfarin

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

LVAD implant

Intervention Description

Subjects will undergo HeartMate 3 LVAD implant prior to randomization

Primary Outcome Measure Information:

Title

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

Description

Composite endpoint in each arm

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Survival free of any stroke

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of ischemic stroke

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of hemorrhagic stroke

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of device thrombosis

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of gastrointestinal bleeding

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of major non-gastrointestinal bleeding

Description

Compared between each study arm

Time Frame

24 weeks

Title

All-cause mortality

Description

Compared between each study arm

Time Frame

24 weeks

Title

Cardiovascular mortality

Description

Compared between each study arm

Time Frame

24 weeks

Title

Survival free of aortic root thrombus

Description

Compared between each study arm

Time Frame

24 weeks

Other Pre-specified Outcome Measures:

Title

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

Description

Compared between each study arm

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

99 Years

Accepts Healthy Volunteers

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 (<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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Bhruga Shah, RN

Phone

703-776-2828

bhruga.shah@inova.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Palak Shah, MD, MS

Organizational Affiliation

Inova Health Care Services

Official's Role

Principal Investigator

Facility Information:

Facility Name

Inova Fairfax Medical Campus

City

Falls Church

State/Province

Virginia

ZIP/Postal Code

22042

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Bhruga Shah, RN

Phone

703-776-2828

Bhruga.Shah@inova.org

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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