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Randomized On-X Anticoagulation Trial

NCT ID: NCT00291525

Last Updated: 2024-12-24

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

977 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-06

Study Completion Date

2023-12-29

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Valve Disease

Keywords

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valve prosthesis antithrombotics randomized

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Number of participants below refers to randomized in all 3 study arms

Study Groups

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AVR Low Risk without warfarin

AVR Low Risk without warfarin

Group Type EXPERIMENTAL

On-X valve using reduced anticoagulation

Intervention Type DEVICE

Valve replacement with antiplatelet agents or lowered warfarin

AVR low risk with standard warfarin

AVR low risk with standard warfarin

Group Type ACTIVE_COMPARATOR

On-X Valve with Standard warfarin Therapy

Intervention Type DEVICE

Valve replacement with standard dosage warfarin

AVR High risk with lower warfarin

AVR High risk with lower warfarin

Group Type EXPERIMENTAL

On-X valve using reduced anticoagulation

Intervention Type DEVICE

Valve replacement with antiplatelet agents or lowered warfarin

AVR High Risk with standard warfarin

AVR High Risk with standard warfarin

Group Type ACTIVE_COMPARATOR

On-X Valve with Standard warfarin Therapy

Intervention Type DEVICE

Valve replacement with standard dosage warfarin

MVR with lower warfarin

MVR with lower warfarin

Group Type EXPERIMENTAL

On-X valve using reduced anticoagulation

Intervention Type DEVICE

Valve replacement with antiplatelet agents or lowered warfarin

MVR with standard warfarin

MVR with standard warfarin

Group Type ACTIVE_COMPARATOR

On-X Valve with Standard warfarin Therapy

Intervention Type DEVICE

Valve replacement with standard dosage warfarin

Interventions

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On-X valve using reduced anticoagulation

Valve replacement with antiplatelet agents or lowered warfarin

Intervention Type DEVICE

On-X Valve with Standard warfarin Therapy

Valve replacement with standard dosage warfarin

Intervention Type DEVICE

Other Intervention Names

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On-X Prosthetic Heart Valve On-X Prosthetic Heart Valve

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinipace Worldwide

INDUSTRY

Sponsor Role collaborator

Acelis Connected Health

UNKNOWN

Sponsor Role collaborator

WCG IRB

UNKNOWN

Sponsor Role collaborator

Avania

INDUSTRY

Sponsor Role collaborator

On-X Life Technologies, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Puskas, MD

Role: STUDY_DIRECTOR

MOUNT SINAI HOSPITAL

Locations

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Tucson Medical Center

Tucson, Arizona, United States

Site Status

Southern Arizona VA Medical Center

Tucson, Arizona, United States

Site Status

Loma Linda University

Loma Linda, California, United States

Site Status

Hartford Hospital

Hartford, Connecticut, United States

Site Status

Christiana Health Care Services

Newark, Delaware, United States

Site Status

Medstar Heart & Vascular Institute

Washington D.C., District of Columbia, United States

Site Status

Shands Hospital - University of Florida

Gainesville, Florida, United States

Site Status

Cardiac Surgical Associates

Kissimmee, Florida, United States

Site Status

South Florida Heart & Lung

Miami, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

St. Francis Heart Center

Indianapolis, Indiana, United States

Site Status

Cotton-O'Neil Clinical Research Center

Topeka, Kansas, United States

Site Status

University of Kentucky

Lexington, Kentucky, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

Brigham & Women's Hospital

Boston, Massachusetts, United States

Site Status

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Mid America Heart institute

Kansas City, Missouri, United States

Site Status

Barnes Jewish Hospital - Washington University

St Louis, Missouri, United States

Site Status

New Mexico Heart Institute

Albuquerque, New Mexico, United States

Site Status

St. Luke's Roosevelt

New York, New York, United States

Site Status

Montefiore Medical Center

New York, New York, United States

Site Status

WakeMed

Raleigh, North Carolina, United States

Site Status

Duke University Medical Center

Raleigh, North Carolina, United States

Site Status

Novant Health

Winston-Salem, North Carolina, United States

Site Status

University Hospital - Cleveland

Cleveland, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

University of Oklahoma/VA Oklahoma City

Oklahoma City, Oklahoma, United States

Site Status

Providence Heart & Vascular Institute

Portland, Oregon, United States

Site Status

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Site Status

Baylor Research Institute

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at Houston

Houston, Texas, United States

Site Status

Texas Heart Institute

Houston, Texas, United States

Site Status

Texas Cardiac Center

Lubbock, Texas, United States

Site Status

Baylor Scott & White - Plano

Plano, Texas, United States

Site Status

Mary Washington Hospital

Fredericksburg, Virginia, United States

Site Status

Sentara Norfolk General Hospital

Norfolk, Virginia, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

MultiCare Health System

Tacoma, Washington, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

St. Luke's Aurora Health Care

Milwaukee, Wisconsin, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia

Vancouver, British Columbia, Canada

Site Status

London Health Science Centre

London, Ontario, Canada

Site Status

Ottawa Heart Institute

Ottawa, Ontario, Canada

Site Status

IUCPQ Chirurgie Cardiaque

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

References

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Puskas JD; PROACT Investigators. Reply: Low-Thrombogenicity Mechanical Heart Valves: Which Antithrombotic Strategy? J Am Coll Cardiol. 2018 Oct 9;72(15):1879-1880. doi: 10.1016/j.jacc.2018.07.063. No abstract available.

Reference Type BACKGROUND
PMID: 30286937 (View on PubMed)

Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A; PROACT Investigators. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.

Reference Type RESULT
PMID: 24512654 (View on PubMed)

Yanagawa B, Levitsky S, Puskas JD; PROACT Investigators. Reduced anticoagulation is safe in high-risk patients with the On-X mechanical aortic valve. Curr Opin Cardiol. 2015 Mar;30(2):140-145. doi: 10.1097/HCO.0000000000000149.

Reference Type RESULT
PMID: 29504958 (View on PubMed)

Puskas JD, Gerdisch M, Nichols D, Fermin L, Rhenman B, Kapoor D, Copeland J, Quinn R, Hughes GC, Azar H, McGrath M, Wait M, Kong B, Martin T, Douville EC, Meyer S, Ye J, Jamieson WRE, Landvater L, Hagberg R, Trotter T, Armitage J, Askew J, Accola K, Levy P, Duncan D, Yanagawa B, Ely J, Graeve A; PROACT Investigators. Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2018 Jun 19;71(24):2717-2726. doi: 10.1016/j.jacc.2018.03.535.

Reference Type RESULT
PMID: 29903344 (View on PubMed)

Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Alexander JH, Puskas JD; PROACT Mitral Investigators. Low-Dose vs Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Trial. Ann Thorac Surg. 2023 Apr;115(4):929-938. doi: 10.1016/j.athoracsur.2022.12.031. Epub 2023 Jan 4.

Reference Type DERIVED
PMID: 36610532 (View on PubMed)

Chu MWA, Ruel M, Graeve A, Gerdisch MW, Damiano RJ Jr, Smith RL 2nd, Keeling WB, Wait MA, Hagberg RC, Quinn RD, Sethi GK, Floridia R, Barreiro CJ, Pruitt AL, Accola KD, Dagenais F, Markowitz AH, Ye J, Sekela ME, Tsuda RY, Duncan DA, Swistel DG, Harville LE 3rd, DeRose JJ, Lehr EJ, Puskas JD; PROACT Mitral Investigators. WITHDRAWN: Low-Dose Versus Standard Warfarin After Mechanical Mitral Valve Replacement: A Randomized Controlled Trial. Ann Thorac Surg. 2022 Jan 28:S0003-4975(22)00138-2. doi: 10.1016/j.athoracsur.2022.01.015. Online ahead of print.

Reference Type DERIVED
PMID: 35101419 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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G050208

Identifier Type: OTHER

Identifier Source: secondary_id

2005-01

Identifier Type: -

Identifier Source: org_study_id