Randomized On-X Anticoagulation Trial

Not Applicable

Completed

Conditions: Heart Valve Disease

Interventions: Device: On-X valve using reduced anticoagulation
Device: On-X Valve with Standard warfarin Therapy

Registration Number: NCT00291525

Lead Sponsor: On-X Life Technologies, Inc.

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

Status: COMPLETED

Sex: All

Target Recruitment: 977

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AVR High risk with lower warfarin	On-X valve using reduced anticoagulation	AVR High risk with lower warfarin
AVR Low Risk without warfarin	On-X valve using reduced anticoagulation	AVR Low Risk without warfarin
AVR High Risk with standard warfarin	On-X Valve with Standard warfarin Therapy	AVR High Risk with standard warfarin
MVR with lower warfarin	On-X valve using reduced anticoagulation	MVR with lower warfarin
MVR with standard warfarin	On-X Valve with Standard warfarin Therapy	MVR with standard warfarin
AVR low risk with standard warfarin	On-X Valve with Standard warfarin Therapy	AVR low risk with standard warfarin

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

Trial Locations

Locations (49): Loma Linda University
🇺🇸
Loma Linda, California, United States
Cardiac Surgical Associates
🇺🇸
Kissimmee, Florida, United States
South Florida Heart & Lung
🇺🇸
Miami, Florida, United States
Brigham & Women's Hospital
🇺🇸
Boston, Massachusetts, United States
University of Kentucky
🇺🇸
Lexington, Kentucky, United States
Barnes Jewish Hospital - Washington University
🇺🇸
Saint Louis, Missouri, United States
New Mexico Heart Institute
🇺🇸
Albuquerque, New Mexico, United States
St. Luke's Roosevelt
🇺🇸
New York, New York, United States
WakeMed
🇺🇸
Raleigh, North Carolina, United States
Duke University Medical Center
🇺🇸
Raleigh, North Carolina, United States
Baylor Research Institute
🇺🇸
Dallas, Texas, United States
University of Texas Southwestern Medical Center
🇺🇸
Dallas, Texas, United States
Texas Cardiac Center
🇺🇸
Lubbock, Texas, United States
Baylor Scott & White - Plano
🇺🇸
Plano, Texas, United States
Sentara Norfolk General Hospital
🇺🇸
Norfolk, Virginia, United States
Mary Washington Hospital
🇺🇸
Fredericksburg, Virginia, United States
MultiCare Health System
🇺🇸
Tacoma, Washington, United States
West Virginia University
🇺🇸
Morgantown, West Virginia, United States
University of Alberta
🇨🇦
Edmonton, Alberta, Canada
Ottawa Heart Institute
🇨🇦
Ottawa, Ontario, Canada
London Health Science Centre
🇨🇦
London, Ontario, Canada
University of British Columbia
🇨🇦
Vancouver, British Columbia, Canada
IUCPQ Chirurgie Cardiaque
🇨🇦
Quebec City, Quebec, Canada
Emory University
🇺🇸
Atlanta, Georgia, United States
Beth Israel Deaconess Medical Center
🇺🇸
Boston, Massachusetts, United States
Texas Heart Institute
🇺🇸
Houston, Texas, United States
University Hospital - Cleveland
🇺🇸
Cleveland, Ohio, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Ohio State University Medical Center
🇺🇸
Columbus, Ohio, United States
University of Pittsburgh Medical Center
🇺🇸
Pittsburgh, Pennsylvania, United States
Swedish Medical Center
🇺🇸
Seattle, Washington, United States
University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
Cotton-O'Neil Clinical Research Center
🇺🇸
Topeka, Kansas, United States
Tucson Medical Center
🇺🇸
Tucson, Arizona, United States
Southern Arizona VA Medical Center
🇺🇸
Tucson, Arizona, United States
Christiana Health Care Services
🇺🇸
Newark, Delaware, United States
Hartford Hospital
🇺🇸
Hartford, Connecticut, United States
Medstar Heart & Vascular Institute
🇺🇸
Washington, District of Columbia, United States
Maine Medical Center
🇺🇸
Portland, Maine, United States
Shands Hospital - University of Florida
🇺🇸
Gainesville, Florida, United States
St. Joseph Mercy Hospital
🇺🇸
Ann Arbor, Michigan, United States
Florida Hospital
🇺🇸
Orlando, Florida, United States
Novant Health
🇺🇸
Winston-Salem, North Carolina, United States
St. Francis Heart Center
🇺🇸
Indianapolis, Indiana, United States
Mid America Heart institute
🇺🇸
Kansas City, Missouri, United States
University of Oklahoma/VA Oklahoma City
🇺🇸
Oklahoma City, Oklahoma, United States
Providence Heart & Vascular Institute
🇺🇸
Portland, Oregon, United States
St. Luke's Aurora Health Care
🇺🇸
Milwaukee, Wisconsin, United States
Montefiore Medical Center
🇺🇸
New York, New York, United States