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Randomized On-X Anticoagulation Trial

This study is currently recruiting participants.
Verified June 2011 by Medical Carbon Research Institute, LLC
Sponsor:
Information provided by (Responsible Party):
Medical Carbon Research Institute, LLC
ClinicalTrials.gov Identifier:
NCT00291525
First received: February 10, 2006
Last updated: March 13, 2013
Last verified: June 2011
History of Changes
  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 Phase
Heart Valve Disease
 Device: On-X valve using reduced anticoagulation
Device: On-X Valve with Standard Coumadin Therapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical Carbon Research Institute, LLC:

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

Secondary Outcome Measures:
  • Rates of other valve related events every 100 patient-years [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Functional classification at each follow-up [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Echo hemodynamics at 1, 3 and 5 years [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: July 2006
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AVR Low Risk without Coumadin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered Coumadin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: 2
AVR low risk with standard Coumadin
 Device: On-X Valve with Standard Coumadin Therapy
Valve replacement with standard dosage Coumadin
Other Name: On-X Prosthetic Heart Valve
Experimental: 3
AVR High risk with lower Coumadin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered Coumadin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: 4
AVR High Risk with standard coumadin
 Device: On-X Valve with Standard Coumadin Therapy
Valve replacement with standard dosage Coumadin
Other Name: On-X Prosthetic Heart Valve
Experimental: 5
MVR with lower Coumadin
 Device: On-X valve using reduced anticoagulation
Valve replacement with antiplatelet agents or lowered Coumadin
Other Name: On-X Prosthetic Heart Valve
Active Comparator: 6
MVR with standard Coumadin
 Device: On-X Valve with Standard Coumadin Therapy
Valve replacement with standard dosage Coumadin
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 20 centers in the United States 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 5 years in each patient.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00291525

Contacts
Contact: John L Ely, MS 512-339-8000 ext 226 jely@onxlti.com
Contact: Stephen E Ottmers, PhD 512-339-8000 ext 254 sottmers@onxlti.com

  Show 34 Study Locations
Sponsors and Collaborators
Medical Carbon Research Institute, LLC
Investigators
Study Director: John Puskas, MD Emory University
  More Information

No publications provided

Responsible Party: Medical Carbon Research Institute, LLC
ClinicalTrials.gov Identifier: NCT00291525     History of Changes
Other Study ID Numbers: 2005-01, G050208
Study First Received: February 10, 2006
Last Updated: March 13, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Medical Carbon Research Institute, LLC:
valve
prosthesis
antithrombotics
randomized

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Warfarin
 Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013