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

Heart Failure Clinical Trial

— DOAC LVAD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04865978
• Other study ID #: U21-06-4470
• Status: Completed
• Phase: Phase 2
• Start date: December 14, 2021
• Est. completion date: November 7, 2023

Study information

• Verified date: December 2023
• Source: Inova Health Care Services
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 7, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Apixaban
Patients randomized to apixaban will be started on a dose of 5 mg BID.
• 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

Locations

Country	Name	City	State
United States	Inova Fairfax Medical Campus	Falls Church	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Palak Shah	Abbott Medical Devices

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Compared between each study arm	24 weeks
Primary	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	24 weeks
Secondary	Survival free of any stroke	Compared between each study arm	24 weeks
Secondary	Survival free of ischemic stroke	Compared between each study arm	24 weeks
Secondary	Survival free of hemorrhagic stroke	Compared between each study arm	24 weeks
Secondary	Survival free of device thrombosis	Compared between each study arm	24 weeks
Secondary	Survival free of gastrointestinal bleeding	Compared between each study arm	24 weeks
Secondary	Survival free of major non-gastrointestinal bleeding	Compared between each study arm	24 weeks
Secondary	All-cause mortality	Compared between each study arm	24 weeks
Secondary	Cardiovascular mortality	Compared between each study arm	24 weeks
Secondary	Survival free of aortic root thrombus	Compared between each study arm	24 weeks