Randomized On-X Anticoagulation Trial

Condition(s) targeted: Heart Valve Disease

Intervention: On-X valve using reduced anticoagulation (Device); On-X Valve with Standard Coumadin Therapy (Device)

Phase: Phase 4

Status: Recruiting

Sponsored by: Medical Carbon Research Institute, LLC

Official(s) and/or principal investigator(s):
John Puskas, MD, Study Director, Affiliation: Emory University

Overall contact:
John L Ely, MS, Phone: 512-339-8000, Ext: 226, Email: ely@mcritx.com

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.

Official title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

Study design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Rate of thromboembolism evaluated every 100 patient-years

Rate of thrombosis evaluated every 100 patient-years

Rate of bleeding events evaluated every 100 patient-years

Secondary outcome:

Rates of other valve related events every 100 patient-years

Functional classification at each follow-up

Echo hemodynamics at 1, 3 and 5 years

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 20 centers in the United States 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 5 years in each

patient.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

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.

John L Ely, MS, Phone: 512-339-8000, Ext: 226, Email: ely@mcritx.com

University of Arizona Medical Center, Tucson, Arizona 85724, United States; Recruiting
Jack Copeland, MD, Phone: 520-626-0933
Robin Conwell, Phone: 520-626-0933
Jack Copeland, MD, Principal Investigator

Southern Arizona VA Medical Center, Tucson, Arizona 85723, United States; Recruiting
Lilibeth Fermin, MD, Phone: 520-792-1450
Janet Ohm, Phone: 520-792-1450, Ext: 5088
Lilibeth Fermin, MD, Principal Investigator
Berger Rhenman, MD, Sub-Investigator

Arizona Heart Institute, Phoenix, Arizona 85006, United States; Recruiting
Grayson H Wheatley, MD, Phone: 602-707-3613
Amy Rosenbaum, Phone: 602-707-3613, Email: arosenbaum@azheart.com
Grayson H Wheatley, MD, Principal Investigator

Loma Linda University, Loma Linda, California 92354, United States; Recruiting
Nan Wang, MD, Phone: 909-558-4354, Email: nwang@llu.edu
Dipal Patel, MD, Phone: 909-558-0348, Email: dpatel@ahs.llumc.edu
Nan Wang, MD, Principal Investigator

Shands Hospital - University of Florida, Gainesville, Florida 32610, United States; Recruiting
Tomas Martin, MD, Phone: 352-273-5505, Email: staplnl@surgery.ufl.edu
Nancy Staples, RN, Phone: 352-273-5496, Email: staplnl@surgery.ufl.edu
Tomas Martin, MD, Principal Investigator

Florida Hospital, Orlando, Florida 32803, United States; Recruiting
Kevin Accola, MD, Phone: 407-897-5600, Email: susan.brettin@flhosp.org
Leigh Ann Goodrum, RN, Phone: 407-657-5600, Ext: 2017, Email: leighann.goodrum@flhosp.org
Kevin Accola, MD, Principal Investigator

Emory University, Atlanta, Georgia 30365, United States; Recruiting
John Puskas, MS, Phone: 404-686-2513, Email: john_puskas@emoryhealthcare.org
Shannon Smith, BSN, Phone: 404-686-2513, Email: shannon.smith@emoryhealthcare.org
John Puskas, MD, Principal Investigator
Omar Lattouf, MD, Sub-Investigator
Robert Guyton, MD, Sub-Investigator

University of Chicago, Chicago, Illinois 60637, United States; Recruiting
Valluvan Jeevanandam, MD, Phone: 773-702-2500, Email: jeevan@uchicago.edu
Shaune Quismundo, RN, Phone: 773-834-5989, Email: squismun@surgery.bsd.uchicago.edu
Valluvan Jeevanandam, MD, Principal Investigator

St. Francis Heart Center, Indianapolis, Indiana 46237, United States; Recruiting
Marc W Gerdisch, MD, Phone: 317-851-2331, Email: mgerdisch@openheart.net
Katherine Lawson, Phone: 317-851-2582, Email: katherine.lawson@ssfhs.org
Marc W Gerdisch, MD, Principal Investigator

Cotton-O'Neil Clinical Research Center, Topeka, Kansas 66604, United States; Recruiting
Sanjay P Tripathi, MD, Phone: 785-233-1710, Email: sanjtripathi@yahoo.com
Erin S Malone, RN, Phone: 785-270-8604, Email: emalone@stormontvail.org
Sanjay Tripathi, MD, Principal Investigator

Maine Medical Center, Portland, Maine 04102, United States; Recruiting
Reed Quinn, MD, Phone: 207-662-6258, Email: quinnr@mmc.org
Jane Kane, RN, Phone: 207-662-6991, Email: kanejan@mmc.org
Reed Quinn, MD, Principal Investigator

Beth Israel Deaconess Medical Center, Boston, Massachusetts 02215, United States; Recruiting
Robert Hagberg, MD, Phone: 617-667-0537, Email: rhagberg@bidmc.harvard.edu
Ann Slater, Phone: 617-632-9868, Email: aslater@bidmc.harvard.edu
Robert Hagberg, MD, Principal Investigator

Barnes Jewish Hospital - Washington University, St. Louis, Missouri 63110, United States; Recruiting
Ralph Damiano, MD, Phone: 314-747-4404
Tracey Guthrie, Phone: 14-747-4404, Email: guthriet@wustl.edu
Ralph Damiano, MD, Principal Investigator

New Mexico Heart Institute, Albuquerque, New Mexico 87102, United States; Recruiting
Paul Levy, MD, Phone: 505-841-1000, Email: paull@nmhi.com
Angela Mindheim, RN, Phone: 505-843-2804, Email: angelam@nmhi.com
Paul Levy, MD, Principal Investigator

WakeMed, Raleigh, North Carolina 27610, United States; Recruiting
Lance Landvater, MD, Phone: 919-231-6333, Email: ggregory@carolinacardiovascular.com
Georgie Gregory, RN, Phone: 919-231-6333, Email: ggregory@carolinacardiovascular.com
Lance Landvater, MD, Principal Investigator

Duke University Medical Center, Raleigh, North Carolina 27710, United States; Recruiting
Chad Hughes, MD, Phone: 919-668-0903, Email: hughe007@mc.duke.edu
Terry Ainsworth, Phone: 919-684-2382, Email: ainsw001@mc.duke.edu
Chad Hughes, MD, Principal Investigator

Ohio State University Medical Center, Columbus, Ohio 43210, United States; Recruiting
C. B. Sai-Sudhakar, MD, Phone: 614-293-7277
Darla Talbott, Phone: 614-293-8173
C. B. Sai-Sudhakar, MD, Principal Investigator

St. Vincent Mercy Medical Center, Toledo, Ohio 43608, United States; Recruiting
Thomas Schwann, MD, Phone: 419-251-4919
Julie Neidhardt, Phone: 419-251-2864, Email: julie_neidhardt@mhsnr.org
Thomas Schwann, MD, Principal Investigator

Lindner Center, Cincinnati, Ohio 45219, United States; Recruiting
Tom Ivey, MD, Phone: 513-651-2313
Darlene Rock, RN, Phone: 513-585-1766, Email: rock.lctc@fuse.net
Tom Ivey, MD, Principal Investigator

University of Oklahoma/VA Oklahoma City, Oklahoma City, Oklahoma 73104, United States; Recruiting
timothy Trotter, MD, Phone: 405-271-5789, Email: timothy-trotter@ouhsc.edu
Theresa Lander, Phone: 405-271-2601, Email: theresa-lander@ouhsc.edu
Timothy Trotter, MD, Principal Investigator
Marvin Peyton, MD, Principal Investigator

Providence Heart & Vascular Institute, Portland, Oregon 97220, United States; Recruiting
Charles Douville, MD, Phone: 503-963-3030, Email: ecdouville@orclinic.com
Amy Bullock, Phone: 503-215-6746, Email: amy.bullock@providence.org
Charles Douville, MD, Principal Investigator

University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States; Recruiting
Joseph Bavaria, MD, Phone: 215-662-2017, Email: joseph.bavaria@uphs.upenn.edu
Lisa Walsh, RN, Phone: 215-662-4289, Email: lisa.walsh@uphs.upenn.edu
Joseph Bavaria, MD, Principal Investigator

Abington Memorial Hospital, Abington, Pennsylvania 19001, United States; Recruiting
Paul Addonizio, MD, Phone: 215-481-4200, Email: vpaddonizio@amh.org
Kathleen Shaughnessy, Phone: 215-481-7158, Email: kshaughnessy@amh.org
Paul Addonizio, MD, Principal Investigator

University of Texas Southwestern Medical Center, Dallas, Texas 75390, United States; Recruiting
Michael Waits, MD, Phone: 214-645-7726
Mary DeLira, Phone: 214-645-7728
Michael Wait, MD, Principal Investigator

Texas Heart Institute, Houston, Texas 77225, United States; Recruiting
Igor Gregoric, MD, Phone: 832-355-3000, Email: igregoric@heart.thi.tmc.edu
Kathy Vershave, Phone: 832-355-8520, Email: kvershave@heart.thi.tmc.edu
Igor Gregoric, MD, Principal Investigator

Sentara Norfolk General Hospital, Norfolk, Virginia 23507, United States; Recruiting
Hormoz Azar, MD, Phone: 757-622-6344
Laura Pine, Phone: 757-668-2732
Hormoz Azar, MD, Principal Investigator

Mary Washington Hospital, Fredericksburg, Virginia 22401, United States; Recruiting
John Armitage, MD, Phone: 540-372-7792
Diana Louder, Phone: 540-741-4657, Email: diana.louder@medicorp.org
John Armitage, MD, Principal Investigator

Virginia Commonwealth University, Richmond, Virginia 23298, United States; Recruiting
Vigneshwar Kasirajan, MD, Phone: 804-828-2774, Email: fakers@vcu.edu
Goeffrey Newton, Phone: 804-628-2520, Email: gnewton@mcvh-vcu.edu
Vigneshwar Kasirajan, MD, Principal Investigator

Tacoma General Hospital, Tacoma, Washington 98415, United States; Recruiting
Dennis Nichols, MD, Phone: 253-403-7257
Janey Barnhart, Phone: 253-403-7252
Dennis Nichols, MD, Principal Investigator

Starting date: July 2006
Ending date: March 2015
Last updated: April 25, 2008