Randomized On-X Anticoagulation Trial

Completed · Not applicable

Conditions studied: Heart Valve Disease

In brief

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.

Key facts

Study ID

NCT00291525

Run by

On-X Life Technologies, Inc.

People needed

977

Starts

2006-06-06

Expected to finish

2023-12-29

Last updated by the study team

2024-12-24

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Tucson Medical Center — Tucson, Arizona, United States
• Southern Arizona VA Medical Center — Tucson, Arizona, United States
• Loma Linda University — Loma Linda, California, United States
• Hartford Hospital — Hartford, Connecticut, United States
• Christiana Health Care Services — Newark, Delaware, United States
• Medstar Heart & Vascular Institute — Washington D.C., District of Columbia, United States
• Shands Hospital - University of Florida — Gainesville, Florida, United States
• Cardiac Surgical Associates — Kissimmee, Florida, United States
• South Florida Heart & Lung — Miami, Florida, United States
• Florida Hospital — Orlando, Florida, United States
• Emory University — Atlanta, Georgia, United States
• St. Francis Heart Center — Indianapolis, Indiana, United States
• Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Maine Medical Center — Portland, Maine, United States
• Brigham & Women's Hospital — Boston, Massachusetts, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• St. Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Mid America Heart institute — Kansas City, Missouri, United States
• Barnes Jewish Hospital - Washington University — St Louis, Missouri, United States
• New Mexico Heart Institute — Albuquerque, New Mexico, United States
• St. Luke's Roosevelt — New York, New York, United States
• Montefiore Medical Center — New York, New York, United States
• WakeMed — Raleigh, North Carolina, United States
• Duke University Medical Center — Raleigh, North Carolina, United States

Full record on ClinicalTrials.gov

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