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Randomized On-X Anticoagulation Trial (PROACT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00291525
Recruitment Status : Active, not recruiting
First Posted : February 14, 2006
Last Update Posted : September 14, 2022
Sponsor:
Collaborators:
Clinipace Worldwide
Acelis Connected Health
WCG IRB
Avania
Information provided by (Responsible Party):
On-X Life Technologies, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Heart Valve Disease Device: On-X valve using reduced anticoagulation Device: On-X Valve with Standard warfarin Therapy Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)
Actual Study Start Date : June 6, 2006
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AVR Low Risk without warfarin
AVR Low Risk without warfarin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: AVR low risk with standard warfarin
AVR low risk with standard warfarin
 Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Name: On-X Prosthetic Heart Valve
Experimental: AVR High risk with lower warfarin
AVR High risk with lower warfarin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: AVR High Risk with standard warfarin
AVR High Risk with standard warfarin
 Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Name: On-X Prosthetic Heart Valve
Experimental: MVR with lower warfarin
MVR with lower warfarin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered warfarin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: MVR with standard warfarin
MVR with standard warfarin
 Device: On-X Valve with Standard warfarin Therapy
Valve replacement with standard dosage warfarin
Other Name: On-X Prosthetic Heart Valve


Outcome Measures
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Primary Outcome Measures :
  1. Thromboembolism [ Time Frame: 8 years ]
    Rate of thromboembolism evaluated every 100 patient-years

  2. Valve Thrombosis [ Time Frame: 8 years ]
    Rate of thrombosis evaluated every 100 patient-years

  3. Bleeding Events [ Time Frame: 8 years ]
    Rate of major and minor bleeding events evaluated every 100 patient-years


Secondary Outcome Measures :
  1. Valve-Related Events [ Time Frame: 8 years ]
    Rates of other valve-related events (e.g. prosthetic valve dysfunction, hemolysis, hemolytic anemia, endocarditis) every 100 patient-years

  2. New York Heart Association (NYHA) classification [ Time Frame: 8 years ]
    Functional classification at each follow-up

  3. Valve Hemodynamics [ Time Frame: 5 years ]
    Echocardiograpic measures of valve hemodynamics at 1, 3 and 5 years


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00291525


Locations
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Sponsors and Collaborators
On-X Life Technologies, Inc.
Clinipace Worldwide
Acelis Connected Health
WCG IRB
Avania
Investigators
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Study Director: John Puskas, MD MOUNT SINAI HOSPITAL
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: On-X Life Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00291525    
Other Study ID Numbers: 2005-01
G050208 ( Other Identifier: FDA )
First Posted: February 14, 2006    Key Record Dates
Last Update Posted: September 14, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by On-X Life Technologies, Inc.:
valve
prosthesis
antithrombotics
randomized
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants