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Randomized On-X Anticoagulation Trial (PROACT)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by On-X Life Technologies, Inc.
Sponsor:
Collaborators:
Clinipace LTD
Alere, Inc.
Information provided by (Responsible Party):
On-X Life Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00291525
First received: February 10, 2006
Last updated: April 11, 2017
Last verified: April 2017
  Purpose
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 Intervention
Heart Valve Disease Device: On-X valve using reduced anticoagulation Device: On-X Valve with Standard warfarin Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Prevention
Official Title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

Resource links provided by NLM:


Further study details as provided by On-X Life Technologies, Inc.:

Primary Outcome Measures:
  • Rate of thromboembolism evaluated every 100 patient-years [ Time Frame: 5 years ]
  • Rate of thrombosis evaluated every 100 patient-years [ Time Frame: 5 years ]
  • Rate of bleeding events evaluated every 100 patient-years [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Rates of other valve related events every 100 patient-years [ Time Frame: 5 years ]
  • Functional classification at each follow-up [ Time Frame: 5 years ]
  • Echo hemodynamics at 1, 3 and 5 years [ Time Frame: 5 years ]

Other Outcome Measures:
  • Other Outcomes [ Time Frame: 5 years ]
    There are no other outcomes


Estimated Enrollment: 1200
Study Start Date: July 2006
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 and Canada enrolling 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 enrollment to 1000. The high risk arm is completed with FDA review and this arm had 375 enrollees. The mitral arm continues to enroll with a planned enrollment of 400.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00291525

Contacts
Contact: Gretchen Wilderspin, MS 678-290-4309 wilderspin.gretchen@cryolife.com
Contact: Stephen E Ottmers, PhD 512-580-2254 ottmers.stephen@cryolife.com

  Show 42 Study Locations
Sponsors and Collaborators
On-X Life Technologies, Inc.
Clinipace LTD
Alere, Inc.
Investigators
Study Director: John Puskas, MD Mount Sinai Hospital, New York
  More Information

Publications:
Responsible Party: On-X Life Technologies, Inc.
ClinicalTrials.gov Identifier: NCT00291525     History of Changes
Other Study ID Numbers: 2005-01
G050208 ( Other Identifier: FDA )
Study First Received: February 10, 2006
Last Updated: April 11, 2017
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:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
Anticoagulants

ClinicalTrials.gov processed this record on July 21, 2017