Randomized On-X Anticoagulation Trial
PROACT
Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
2 other identifiers
interventional
977
2 countries
49
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2006
Longer than P75 for not_applicable
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 10, 2006
CompletedFirst Posted
Study publicly available on registry
February 14, 2006
CompletedStudy Start
First participant enrolled
June 6, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 8, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 29, 2023
CompletedResults Posted
Study results publicly available
December 24, 2024
CompletedDecember 24, 2024
October 1, 2024
17.2 years
February 10, 2006
February 7, 2024
December 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Thromboembolism
Percentage of events per patient year
8 years
Valve Thrombosis
Percentage of events per patient year
8 years
Bleeding Events
Percentage of events per patient year
8 years
Secondary Outcomes (2)
Valve-Related Mortality
8 years
Valve Hemodynamics
5 years
Study Arms (6)
AVR Low Risk without warfarin
EXPERIMENTALAVR Low Risk without warfarin
AVR low risk with standard warfarin
ACTIVE COMPARATORAVR low risk with standard warfarin
AVR High risk with lower warfarin
EXPERIMENTALAVR High risk with lower warfarin
AVR High Risk with standard warfarin
ACTIVE COMPARATORAVR High Risk with standard warfarin
MVR with lower warfarin
EXPERIMENTALMVR with lower warfarin
MVR with standard warfarin
ACTIVE COMPARATORMVR with standard warfarin
Interventions
Valve replacement with antiplatelet agents or lowered warfarin
Valve replacement with standard dosage warfarin
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- On-X Life Technologies, Inc.lead
- Clinipace Worldwidecollaborator
- Acelis Connected Healthcollaborator
- WCG IRBcollaborator
- Avaniacollaborator
Study Sites (49)
Tucson Medical Center
Tucson, Arizona, 85718, United States
Southern Arizona VA Medical Center
Tucson, Arizona, 85723, United States
Loma Linda University
Loma Linda, California, 92354, United States
Hartford Hospital
Hartford, Connecticut, 06102, United States
Christiana Health Care Services
Newark, Delaware, 19713, United States
Medstar Heart & Vascular Institute
Washington D.C., District of Columbia, 20010, United States
Shands Hospital - University of Florida
Gainesville, Florida, 32610, United States
Cardiac Surgical Associates
Kissimmee, Florida, 34741, United States
South Florida Heart & Lung
Miami, Florida, 33133, United States
Florida Hospital
Orlando, Florida, 32803, United States
Emory University
Atlanta, Georgia, 30365, United States
St. Francis Heart Center
Indianapolis, Indiana, 46237, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66604, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Maine Medical Center
Portland, Maine, 04102, United States
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
St. Joseph Mercy Hospital
Ann Arbor, Michigan, 48197, United States
Mid America Heart institute
Kansas City, Missouri, 64111, United States
Barnes Jewish Hospital - Washington University
St Louis, Missouri, 63110, United States
New Mexico Heart Institute
Albuquerque, New Mexico, 87102, United States
St. Luke's Roosevelt
New York, New York, 10025, United States
Montefiore Medical Center
New York, New York, 10461, United States
WakeMed
Raleigh, North Carolina, 27610, United States
Duke University Medical Center
Raleigh, North Carolina, 27710, United States
Novant Health
Winston-Salem, North Carolina, 27104, United States
University Hospital - Cleveland
Cleveland, Ohio, 44106, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Ohio State University Medical Center
Columbus, Ohio, 43210, United States
University of Oklahoma/VA Oklahoma City
Oklahoma City, Oklahoma, 73104, United States
Providence Heart & Vascular Institute
Portland, Oregon, 97220, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213, United States
Baylor Research Institute
Dallas, Texas, 75226, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
Texas Heart Institute
Houston, Texas, 77225, United States
Texas Cardiac Center
Lubbock, Texas, 79410, United States
Baylor Scott & White - Plano
Plano, Texas, 78093, United States
Mary Washington Hospital
Fredericksburg, Virginia, 22401, United States
Sentara Norfolk General Hospital
Norfolk, Virginia, 23507, United States
Swedish Medical Center
Seattle, Washington, 98122, United States
MultiCare Health System
Tacoma, Washington, 98415, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
St. Luke's Aurora Health Care
Milwaukee, Wisconsin, 53215, United States
University of Alberta
Edmonton, Alberta, 76G 2B7, Canada
University of British Columbia
Vancouver, British Columbia, V6Z 1Y6, Canada
London Health Science Centre
London, Ontario, N6A 5A5, Canada
Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
IUCPQ Chirurgie Cardiaque
Québec, Quebec, G1V 4G5, Canada
Related Publications (6)
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.
PMID: 30286937BACKGROUNDPuskas 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.
PMID: 24512654RESULTYanagawa 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.
PMID: 29504958RESULTPuskas 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.
PMID: 29903344RESULTChu 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.
PMID: 36610532DERIVEDChu 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.
PMID: 35101419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
1. Study collected/reported events based on AATS/STS Guidelines (events of interest, with no serious/non-serious distinction). 2. Enrollment started 2006 for 3 arms: AVR Low Risk - Enrollment \& follow-up terminated 2014, indication not pursued AVR High Risk - Enrollment ended 2009, follow up completed 2014, low INR indication granted MVR - Enrollment ended 2020, follow up completed 2023, indication not pursued 3. Total SAEs is total of all categories presented minus mortality
Results Point of Contact
- Title
- Clinical Project Manager (Yael Goode)
- Organization
- Artivion
Study Officials
- STUDY DIRECTOR
John Puskas, MD
MOUNT SINAI HOSPITAL
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Number of participants below refers to randomized in all 3 study arms
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2006
First Posted
February 14, 2006
Study Start
June 6, 2006
Primary Completion
August 8, 2023
Study Completion
December 29, 2023
Last Updated
December 24, 2024
Results First Posted
December 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share