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

NCT04865978 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-11-14

Study results available
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Summary

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

Conditions

Interventions

DRUG

Apixaban

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

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

Sponsors & Collaborators

  • Abbott Medical Devices

    collaborator INDUSTRY

  • Palak Shah

    lead OTHER

Principal Investigators

  • Palak Shah, MD, MS · Inova Health Care Services

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-14
Primary Completion
2023-10-05
Completion
2023-11-07
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04865978 on ClinicalTrials.gov