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PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

NCT04142658 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 863

Last updated 2024-03-20

Study results available
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Summary

Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.

Conditions

  • Aortic Valve Disease
  • Aortic Valve Stenosis
  • Aortic Valve Failure

Interventions

DRUG

Apixaban 5 MG

For patients that do NOT meet the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)

DRUG

Apixaban 2.5 MG

For patients that meet at least 2 of the following criteria * age ≥ 80 years * weight ≤ 60 kilograms * creatinine ≥ 1.5 mg/dL (133 micromol/L)

DRUG

Warfarin

Active Control Intervention

DEVICE

On-X Aortic Mechanical Valve

Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.

Sponsors & Collaborators

  • Duke Clinical Research Institute

    collaborator OTHER

  • Artivion Inc.

    lead INDUSTRY

Principal Investigators

  • Lars Svensson, MD, PhD · Steering Committee

  • John Alexander, MD · Steering Committee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-01
Primary Completion
2022-12-12
Completion
2022-12-12
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04142658 on ClinicalTrials.gov