Randomized On-X Anticoagulation Trial - Full Text View

Sponsored by:	Medical Carbon Research Institute, LLC
Information provided by:	Medical Carbon Research Institute, LLC
ClinicalTrials.gov Identifier:	NCT00291525

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 IV

MedlinePlus related topics: Blood Thinners Heart Valve Diseases

Drug Information available for: Warfarin Warfarin potassium Warfarin sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Prospective Randomized On-X Anticoagulation Clinical Trial (PROACT)

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
1: Experimental AVR Low Risk without Coumadin	Device: On-X valve using reduced anticoagulation Valve replacement with antiplatelet agents or lowered Coumadin
2: Active Comparator AVR low risk with standard Coumadin	Device: On-X Valve with Standard Coumadin Therapy Valve replacement with standard dosage Coumadin
3: Experimental AVR High risk with lower Coumadin	Device: On-X valve using reduced anticoagulation Valve replacement with antiplatelet agents or lowered Coumadin
4: Active Comparator AVR High Risk with standard coumadin	Device: On-X Valve with Standard Coumadin Therapy Valve replacement with standard dosage Coumadin
5: Experimental MVR with lower Coumadin	Device: On-X valve using reduced anticoagulation Valve replacement with antiplatelet agents or lowered Coumadin
6: Active Comparator MVR with standard Coumadin	Device: On-X Valve with Standard Coumadin Therapy Valve replacement with standard dosage Coumadin

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	ely@mcritx.com
Contact: Stephen E Ottmers, PhD	512-339-8000 ext 254	ottmers@mcritx.com

Show 37 Study Locations

Sponsors and Collaborators

Medical Carbon Research Institute, LLC

Investigators

Study Director:

John Puskas, MD

Emory University

More Information

Responsible Party:	On-X Life Technologies, Inc. ( John Ely, Executive Vive President )
Study ID Numbers:	2005-01, G050208
Study First Received:	February 10, 2006
Last Updated:	December 31, 2008
ClinicalTrials.gov Identifier:	NCT00291525
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Medical Carbon Research Institute, LLC:

valve
prosthesis
antithrombotics
randomized

Study placed in the following topic categories:

Heart Diseases
Warfarin
Heart Valve Diseases

Additional relevant MeSH terms:

Anticoagulants
Therapeutic Uses
Hematologic Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009