Randomized On-X Anticoagulation Trial

Not Applicable

Completed

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.

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 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.

Recruitment & Eligibility

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.

Primary Outcome Measures

Name	Time	Method
Thromboembolism	8 years	Percentage of events per patient year
Valve Thrombosis	8 years	Percentage of events per patient year
Bleeding Events	8 years	Percentage of events per patient year

Secondary Outcome Measures

Name	Time	Method
Valve Hemodynamics	5 years	Echocardiograpic measures of valve hemodynamics at 5 years
Valve-Related Mortality	8 years	Percentage of events per patient year

Locations (49): 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, 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
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Tucson Medical Center
🇺🇸Tucson, Arizona, United States