Randomized On-X Anticoagulation Trial (PROACT)

September 13, 2022 updated by: On-X Life Technologies, Inc.

Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

Various patient groups with the On-X Valve can be maintained safely on lower doses of blood thinner(Coumadin®) or on antiplatelet drugs (aspirin/Plavix®) only rather than the standard dose of Coumadin and aspirin presently recommended by ACC/AHA or ACCP professional societies.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a longitudinal, randomized (randomization to occur at the 3-month follow-up) study comparing the On-X valve on low dose anticoagulation (test group) to concomitant control groups of On-X valves receiving standard Coumadin/aspirin therapy, and also to FDA objective performance criteria (OPC) for heart valve replacement. It is a multicenter study consisting of up to 50 centers in the United States, Canada, and Italy enrolling and randomizing no more than 1200 patients (200 in each of 6 groups). There are three test arms of the study: low risk aortic valve replacement, high risk aortic valve replacement, and mitral valve replacement. Each arm has an equivalent control. Test therapies are: low risk aortic valve replacement - aspirin/Plavix, high risk aortic valve replacement - Coumadin at INR of 1.5 to 2.0 plus aspirin, and mitral valve replacement - Coumadin at an INR of 2.0 to 2.5 plus aspirin. Follow-up will run for up to 8 years in each patient. Each arm is independent and the low risk aortic and high risk aortic arms are completed. The low risk aortic arm was closed early resulting in a reduction of the estimated total enrollment with randomization to 1000. The high risk arm is completed with FDA review and this arm had 375 randomized enrollees. The mitral arm continues to enroll with a planned randomized enrollment of 400.

Study Type

Interventional

Enrollment (Anticipated)

1200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, 76G 2B7
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • University of British Columbia
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Science Centre
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Ottawa Heart Institute
    • Quebec
      • Quebec City, Quebec, Canada, G1V 4G5
        • IUCPQ Chirurgie Cardiaque
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85723
        • Southern Arizona VA Medical Center
      • Tucson, Arizona, United States, 85718
        • Tucson Medical Center
    • California
      • Loma Linda, California, United States, 92354
        • Loma Linda University
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Hartford Hospital
    • Delaware
      • Newark, Delaware, United States, 19713
        • Christiana Health Care Services
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Medstar Heart & Vascular Institute
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital - University of Florida
      • Kissimmee, Florida, United States, 34741
        • Cardiac Surgical Associates
      • Miami, Florida, United States, 33133
        • South Florida Heart & Lung
      • Orlando, Florida, United States, 32803
        • Florida Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30365
        • Emory University
    • Indiana
      • Indianapolis, Indiana, United States, 46237
        • St. Francis Heart Center
    • Kansas
      • Topeka, Kansas, United States, 66604
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky
    • Maine
      • Portland, Maine, United States, 04102
        • Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02115
        • Brigham & Women's Hospital
    • Michigan
      • Ann Arbor, Michigan, United States, 48197
        • St. Joseph Mercy Hospital
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Mid America Heart Institute
      • Saint Louis, Missouri, United States, 63110
        • Barnes Jewish Hospital - Washington University
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • New Mexico Heart Institute
    • New York
      • New York, New York, United States, 10461
        • Montefiore Medical Center
      • New York, New York, United States, 10025
        • St. Luke's Roosevelt
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • WakeMed
      • Raleigh, North Carolina, United States, 27710
        • Duke University Medical Center
      • Winston-Salem, North Carolina, United States, 27104
        • Novant Health
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
      • Cleveland, Ohio, United States, 44106
        • University Hospital - Cleveland
      • Columbus, Ohio, United States, 43210
        • Ohio State University Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma/VA Oklahoma City
    • Oregon
      • Portland, Oregon, United States, 97220
        • Providence Heart & Vascular Institute
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Dallas, Texas, United States, 75226
        • Baylor Research Institute
      • Houston, Texas, United States, 77030
        • University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77225
        • Texas Heart Institute
      • Lubbock, Texas, United States, 79410
        • Texas Cardiac Center
      • Plano, Texas, United States, 78093
        • Baylor Scott & White - Plano
    • Virginia
      • Fredericksburg, Virginia, United States, 22401
        • Mary Washington Hospital
      • Norfolk, Virginia, United States, 23507
        • Sentara Norfolk General Hospital
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center
      • Tacoma, Washington, United States, 98415
        • MultiCare Health System
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Aurora Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients requiring isolated aortic valve replacement (AVR), or isolated mitral valve replacement (MVR).

  • AVR patients receiving low dose or antiplatelet only anticoagulation will be divided into groups at low risk and high risk for thromboembolism with all patients being in the low risk group except for patients with the following conditions which place a patient in the high risk group:

    • Chronic atrial fibrillation
    • Left ventricular ejection fraction < 30 %
    • Enlarged left atrium >50mm diameter
    • Spontaneous echo contrasts in the left atrium
    • Vascular pathology
    • Neurological events
    • Hypercoagulability
    • Left or right ventricular aneurysm
    • Lack of platelet response to aspirin or clopidogrel
    • Women receiving estrogen replacement therapy
  • Concomitant cardiac surgery is allowed
  • Adult patients

Exclusion Criteria:

  • Right side valve replacement
  • Double (aortic plus mitral) valve replacement
  • Patients with active endocarditis at the time of implant
  • Previous confirmed or suspected thromboembolic event or thrombophlebitis
  • Other terminal illness
  • Patients who are in an emergency state
  • Inability to return for required follow-ups
  • Patients with an On-X valve implanted within the study and subsequently explanted
  • Patients who are known to be pregnant, plan to become pregnant or are lactating
  • Patients with acquired immunodeficiency syndrome or know to be HIV positive
  • Patients who are prison inmates or known drug or alcohol abusers
  • Patients unable to give adequate informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AVR Low Risk without warfarin
Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Names:
  • On-X Prosthetic Heart Valve
Active Comparator: AVR low risk with standard warfarin
Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Names:
  • On-X Prosthetic Heart Valve
Experimental: AVR High risk with lower warfarin
Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Names:
  • On-X Prosthetic Heart Valve
Active Comparator: AVR High Risk with standard warfarin
Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Names:
  • On-X Prosthetic Heart Valve
Experimental: MVR with lower warfarin
Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Names:
  • On-X Prosthetic Heart Valve
Active Comparator: MVR with standard warfarin
Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Names:
  • On-X Prosthetic Heart Valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thromboembolism
Time Frame: 8 years
Rate of thromboembolism evaluated every 100 patient-years
8 years
Valve Thrombosis
Time Frame: 8 years
Rate of thrombosis evaluated every 100 patient-years
8 years
Bleeding Events
Time Frame: 8 years
Rate of major and minor bleeding events evaluated every 100 patient-years
8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Valve-Related Events
Time Frame: 8 years
Rates of other valve-related events (e.g. prosthetic valve dysfunction, hemolysis, hemolytic anemia, endocarditis) every 100 patient-years
8 years
New York Heart Association (NYHA) classification
Time Frame: 8 years
Functional classification at each follow-up
8 years
Valve Hemodynamics
Time Frame: 5 years
Echocardiograpic measures of valve hemodynamics at 1, 3 and 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

On-X Life Technologies, Inc.

Collaborators

Clinipace Worldwide
Avania
Acelis Connected Health
WCG IRB

Investigators

  • Study Director: John Puskas, MD, Mount Sinai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2006

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimate)

February 14, 2006

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2005-01
  • G050208 (Other Identifier: FDA)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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