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.
Brief Title
Randomized On-X Anticoagulation Trial
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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Heart Valve Disease
Eligibility 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.
* 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.
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
valve
prosthesis
antithrombotics
randomized
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT00291525
Org Class
Industry
Org Full Name
On-X Life Technologies, Inc.
Org Study Id
2005-01
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
Primary Outcomes
Outcome Description
Percentage of events per patient year
Outcome Measure
Thromboembolism
Outcome Time Frame
8 years
Outcome Description
Percentage of events per patient year
Outcome Measure
Valve Thrombosis
Outcome Time Frame
8 years
Outcome Description
Percentage of events per patient year
Outcome Measure
Bleeding Events
Outcome Time Frame
8 years
Secondary Ids
Secondary Id
G050208
Secondary Outcomes
Outcome Description
Percentage of events per patient year
Outcome Time Frame
8 years
Outcome Measure
Valve-Related Mortality
Outcome Description
Echocardiograpic measures of valve hemodynamics at 5 years
Outcome Time Frame
5 years
Outcome Measure
Valve Hemodynamics
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
David D'Alessandro
Investigator Email
ddalessa@montefiore.org
Investigator Phone