Randomized On-X Anticoagulation Trial



Status:Recruiting
Conditions:Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:18 - 70
Updated:9/28/2017
Start Date:July 2006
End Date:March 2020
Contact:Gretchen Wilderspin, MS
Email:wilderspin.gretchen@cryolife.com
Phone:678-290-4309

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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.

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 and Canada enrolling 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 enrollment to 1000. The high risk arm is completed
with FDA review and this arm had 375 enrollees. The mitral arm continues to enroll with a
planned enrollment of 400.

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.
We found this trial at
38
sites
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Principal Investigator: John Puskas, MD
Phone: 404-686-2513
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
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Atlanta, GA
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Gosta Pettersson, MD
Phone: 216-444-2035
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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Cleveland, OH
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Gainesville, FL
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720 W Oak St # 360
Kissimmee, Florida 34741
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22 Bramhall St
Portland, Maine 04102
(207) 662-0111
Principal Investigator: Reed Quinn, MD
Phone: 207-662-6258
Maine Medical Center One of the country's consistently highest rated hospitals is right in your...
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823 SW Mulvane St
Topeka, Kansas 66606
785-368-0741
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Albuquerque, New Mexico 87102
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Ann Arbor, Michigan 48197
Principal Investigator: Bobby K Kong, MD
Phone: 734-712-5500
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Columbus, OH
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3310 Live Oak St
Dallas, Texas 75204
(214) 820-2687
Baylor Research Institute Baylor Research Institute (BRI) is a dedicated research center for finding prevention...
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: Michael Wait, MD
Phone: 214-645-7726
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Edmonton, Alberta T6G 2J2
Principal Investigator: Steven Meyer, MD
Phone: 780-407-1959
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Edmonton,
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Fredericksburg, Virginia 22401
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80 Seymour St
Hartford, Connecticut 6102
(860) 545-5000
Principal Investigator: Robert Hagberg, MD
Phone: 860-696-5520
The Hartford Hospital Hartford Hospital is the major teaching hospital affiliated with the University of...
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Houston, Texas 77225
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Indianapolis, Indiana 46237
Principal Investigator: Marc W Gerdisch, MD
Phone: 317-851-2331
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Kansas City, Missouri 64111
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Loma Linda University
Loma Linda, California 92354
(909) 558-4000
Principal Investigator: Nan Wang, MD
Phone: 909-558-4354
Loma Linda University Loma Linda University (LLU) is a Seventh-day Adventist educational health-sciences institution with...
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Lubbock, Texas 79410
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Miami, Florida 33133
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Milwaukee, Wisconsin 53215
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New York, New York 10019
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New York, New York 10467
Principal Investigator: Ricardo Bello, MD
Phone: 718-405-8373
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Newark, Delaware 19713
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600 Gresham Dr
Norfolk, Virginia 23507
(757) 388-3000
Principal Investigator: Michael McGrath, MD
Phone: 757-622-6344
Sentara Norfolk General Hospital Sentara Norfolk General Hospital is recognized as the number one ranked...
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Oklahoma City, Oklahoma 73104
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601 E Rollins St
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: Kevin Accola, MD
Phone: 407-897-5600
Florida Hospital Florida Hospital is one of the country
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
Principal Investigator: Vinay Badhwar, MD
Phone: 412-648-6314
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Portland, Oregon 97220
Principal Investigator: Charles Douville, MD
Phone: 503-963-3030
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Raleigh, North Carolina 27610
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Raleigh, North Carolina 27710
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Saint Louis, Missouri 63110
Principal Investigator: Ralph Damiano, MD
Phone: 314-747-4404
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Principal Investigator: Glenn Barnhart, MD
Phone: 206-215-1500
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tacoma, Washington 98415
Principal Investigator: Dennis Nichols, MD
Phone: 253-403-7257
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Tucson, Arizona 85712
Principal Investigator: Gulshan Sethi, MD
Phone: 520-696-4780
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Tucson, Arizona 85723
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Winston-Salem, North Carolina 27103
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