Loading clinical trials...

Evaluation of the Hemocompatibility of the Direct Oral Anti-Coagulant Apixaban in Left Ventricular Assist Devices | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT04865978•Palak Shah

View on ClinicalTrials.gov

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).

Eligibility

Age

18 - 99 years

Sex

ALL

Healthy Volunteers

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 more criteria

Locations (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

Key Dates

Start Date

December 14, 2021

Primary Completion Date

October 5, 2023

Completion Date

November 7, 2023

Last Updated

November 14, 2024

Enrollment

ACTUAL participants

Conditions

Heart Failure

Interventions

Apixaban

DRUG

Warfarin

DRUG

LVAD implant

DEVICE

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

NCT07191730

CardiotoxicityHeart Failure+2 more

View study

RECRUITINGNA

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

NCT07484009

Acute Heart Failure (AHF)Heart Failure (for Example, Fluid Overload)+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 14, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

ML Score Prediction of Cardiotoxicity in Cancer Patients Receiving Anthracycline Chemotherapy or HER2-Targeted Therapies

ReDS-guided Decongestion Strategy in Patients Hospitalized for Heart Failure

Proof-of-concept of a Behavioral Intervention to Improve the Cardiovascular Health of People Living With HIV

Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Autologous Induced Pluripotent Stem Cells of Cardiac Lineage for Congenital Heart Disease

Respiratory Virus Infections in Acute Heart Failure