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PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

Primary Purpose

Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Apixaban 5 MG
Apixaban 2.5 MG
Warfarin
On-X Aortic Mechanical Valve
Sponsored by
Artivion Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female at least 18 years of age at the time of giving informed consent.
  • Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.
  • Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.
  • Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
  • Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.
  • Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.

Exclusion Criteria:

  • Mechanical valve in any position other than aortic valve.
  • Any cardiac surgery in the three months (90 days) prior to enrollment.
  • Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).
  • Known hypersensitivity or other contraindication to apixaban.
  • On dialysis or a creatinine clearance < 25 mL/min.
  • Ischemic stroke or intracranial hemorrhage within 3 months.
  • Active pathological bleeding at the time of screening for enrollment.
  • Active endocarditis at the time of screening for enrollment.
  • Pregnant, plan to become pregnant, or are breast feeding.
  • On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.
  • History of non-compliance with recommended monthly INR testing.

Sites / Locations

  • Tucson Heart Center
  • CHI St. Vincent Heart Institute
  • Loma Linda University Medical Center
  • Stanford University Medical Center
  • Sharp Memorial
  • Hartford Hospital
  • Yale- New Haven Hospital
  • Baycare Health / Morton Plant Hospital
  • Shands Hospital (University of Florida Health)
  • AdventHealth Orlando
  • Tallahassee Research Institute
  • University of South Florida
  • Piedmont Atlanta Hospital
  • Emory University Hospital
  • Northeast Georgia Medical Center
  • Wellstar Kennestone Hospital
  • Northwestern Memorial Hospital
  • OSF Cardiovascular Institute
  • Indiana University Health Methodist Hospital
  • Franciscan Health Indianapolis
  • University of Iowa
  • Maine Medical Center
  • John's Hopkins University
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • University of Michigan Health
  • Abbott Northwestern Hospital
  • University of Minnesota
  • Mayo Clinic Rochester
  • Saint Luke's Hospital
  • Washington University Medical Center
  • Missouri Baptist Medical Center
  • University of Nebraska Medical Center
  • Mount Sinai- St. Luke's Hospital
  • NewYork-Presbyterian Hospital
  • NewYork-Presbyterian/ Weill Cornell Medical Center
  • Vassar Brothers Medical Center
  • University of Rochester Medical Center
  • Atrium Health Carolinas Medical Center (CMC)
  • Duke University
  • Cleveland Clinic
  • ProMedica Toledo Hospital
  • Oklahoma Heart Hospital
  • Lehigh Valley Hospital Allentown
  • Penn State Health Milton S. Hershey Medical Center
  • Hospital of the University of Pennsylvania
  • Thomas Jefferson University
  • UPMC Shadyside
  • Avera Health / North Central Heart
  • Tristar Centennial Medical Center
  • William P. Clements Jr. University Hospital
  • TCU School of Medicine
  • The University of Texas Health Science Center at Houston
  • The Heart Hospital at Baylor Plano
  • University of Utah Hospital
  • Henrico Doctors' Hospital
  • Carilion Roanoke Memorial Hospital
  • Swedish Medical Center
  • University of Washington Medical Center
  • Tacoma General Hospital
  • University of Wisconsin
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

Warfarin

Arm Description

Apixaban 5 mg twice daily(BID) or 2.5 mg BID

Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)

Outcomes

Primary Outcome Measures

Co-Primary Efficacy Objective
To determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X mechanical heart valve implanted in the aortic position for the primary composite outcome of valve thrombosis and valve-related thromboembolism.
Co-Primary Efficacy Objective
To determine if apixaban provides acceptable anticoagulation for patients with an On-X mechanical heart valve implanted in the aortic position for the primary composite outcome of valve thrombosis and valve-related thromboembolism compared with an objective performance criterion.
Number of major bleeding events (superiority)
To determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) in the safety outcome of major bleeding in patients with an On-X mechanical heart valve implanted in the aortic position.

Secondary Outcome Measures

Number of valve-related thrombotic events (superiority)
To determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) for the primary composite outcome of valve thrombosis and valve-related thromboembolism in patients with an On-X mechanical heart valve implanted in the aortic position.
Secondary Efficacy Objective
To compare apixaban with warfarin (INR target range 2.0 - 3.0) for the individual components of the primary outcome (valve thrombosis and valve-related thromboembolism) in patients with an On-X mechanical heart valve implanted in the aortic position.
Secondary Efficacy Objective
To compare apixaban with warfarin (INR target range 2.0 - 3.0) for the primary composite outcome of valve thrombosis and valve-related thromboembolism in prespecified subgroups of patients with an On-X mechanical heart valve implanted in the aortic position.

Full Information

First Posted
October 9, 2019
Last Updated
May 15, 2023
Sponsor
Artivion Inc.
Collaborators
Duke Clinical Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04142658
Brief Title
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Official Title
A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Terminated
Why Stopped
Safety
Study Start Date
May 1, 2020 (Actual)
Primary Completion Date
December 12, 2022 (Actual)
Study Completion Date
December 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Artivion Inc.
Collaborators
Duke Clinical Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.
Detailed Description
There is an unmet clinical need for an alternative to warfarin, such as a direct oral anticoagulant (DOAC), as anticoagulation in participants with an aortic mechanical prosthetic valve. Some participants may be genetically hyper- or hypo-responsive to warfarin, which makes management difficult. Another small group of participants is allergic to warfarin. A much larger group of participants has difficulty maintaining warfarin control due to dietary and drug interactions. Finally, the requirement for routine blood testing makes people reluctant to take warfarin. All of these factors drive younger participants in need of aortic valve replacement (AVR) toward selection of a tissue valve instead of a mechanical valve. Despite multiple studies (randomized, matched and risk adjusted) that show that tissue valves are associated with worse outcomes, younger participants choose this type of valve to avoid warfarin. In addition, multiple clinical studies have shown valve reoperation rates are higher for tissue valves used in these younger participants. Providing an alternative to warfarin anticoagulation may lead younger participants to choose a mechanical valve with greater durability and better clinical outcomes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Parallel control and treatment arm at a 1:1 ratio.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
863 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
Apixaban 5 mg twice daily(BID) or 2.5 mg BID
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)
Intervention Type
Drug
Intervention Name(s)
Apixaban 5 MG
Intervention Description
For patients that do NOT meet the following criteria age ≥ 80 years weight ≤ 60 kilograms creatinine ≥ 1.5 mg/dL (133 micromol/L)
Intervention Type
Drug
Intervention Name(s)
Apixaban 2.5 MG
Intervention Description
For patients that meet at least 2 of the following criteria age ≥ 80 years weight ≤ 60 kilograms creatinine ≥ 1.5 mg/dL (133 micromol/L)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
Active Control Intervention
Intervention Type
Device
Intervention Name(s)
On-X Aortic Mechanical Valve
Other Intervention Name(s)
On-X Ascending Aortic Prosthesis (AAP)
Intervention Description
Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
Primary Outcome Measure Information:
Title
Co-Primary Efficacy Objective
Description
To determine if apixaban is non-inferior to warfarin (INR target range 2.0 - 3.0) for patients with an On-X mechanical heart valve implanted in the aortic position for the primary composite outcome of valve thrombosis and valve-related thromboembolism.
Time Frame
2 years
Title
Co-Primary Efficacy Objective
Description
To determine if apixaban provides acceptable anticoagulation for patients with an On-X mechanical heart valve implanted in the aortic position for the primary composite outcome of valve thrombosis and valve-related thromboembolism compared with an objective performance criterion.
Time Frame
2 years
Title
Number of major bleeding events (superiority)
Description
To determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) in the safety outcome of major bleeding in patients with an On-X mechanical heart valve implanted in the aortic position.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Number of valve-related thrombotic events (superiority)
Description
To determine if apixaban is superior to warfarin (INR target range 2.0 - 3.0) for the primary composite outcome of valve thrombosis and valve-related thromboembolism in patients with an On-X mechanical heart valve implanted in the aortic position.
Time Frame
2 years
Title
Secondary Efficacy Objective
Description
To compare apixaban with warfarin (INR target range 2.0 - 3.0) for the individual components of the primary outcome (valve thrombosis and valve-related thromboembolism) in patients with an On-X mechanical heart valve implanted in the aortic position.
Time Frame
2 years
Title
Secondary Efficacy Objective
Description
To compare apixaban with warfarin (INR target range 2.0 - 3.0) for the primary composite outcome of valve thrombosis and valve-related thromboembolism in prespecified subgroups of patients with an On-X mechanical heart valve implanted in the aortic position.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female at least 18 years of age at the time of giving informed consent. Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0. Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use. Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago. Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives [condom or diaphragm with a spermicidal gel], hormonal contraceptives [implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit. Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study. Exclusion Criteria: Mechanical valve in any position other than aortic valve. Any cardiac surgery in the three months (90 days) prior to enrollment. Need to be on aspirin >100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine). Known hypersensitivity or other contraindication to apixaban. On dialysis or a creatinine clearance < 25 mL/min. Ischemic stroke or intracranial hemorrhage within 3 months. Active pathological bleeding at the time of screening for enrollment. Active endocarditis at the time of screening for enrollment. Pregnant, plan to become pregnant, or are breast feeding. On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors. History of non-compliance with recommended monthly INR testing.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Svensson, MD, PhD
Organizational Affiliation
Steering Committee
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
John Alexander, MD
Organizational Affiliation
Steering Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Tucson Heart Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
CHI St. Vincent Heart Institute
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Sharp Memorial
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
Facility Name
Yale- New Haven Hospital
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Baycare Health / Morton Plant Hospital
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Shands Hospital (University of Florida Health)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Tallahassee Research Institute
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30332
Country
United States
Facility Name
Northeast Georgia Medical Center
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
OSF Cardiovascular Institute
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Franciscan Health Indianapolis
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
ZIP/Postal Code
04102
Country
United States
Facility Name
John's Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Abbott Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55902
Country
United States
Facility Name
Saint Luke's Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63105
Country
United States
Facility Name
Missouri Baptist Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63131
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Mount Sinai- St. Luke's Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NewYork-Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
NewYork-Presbyterian/ Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Vassar Brothers Medical Center
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Atrium Health Carolinas Medical Center (CMC)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
ProMedica Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Oklahoma Heart Hospital
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Lehigh Valley Hospital Allentown
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Penn State Health Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
UPMC Shadyside
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Avera Health / North Central Heart
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57108
Country
United States
Facility Name
Tristar Centennial Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
William P. Clements Jr. University Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
TCU School of Medicine
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The Heart Hospital at Baylor Plano
City
Plano
State/Province
Texas
ZIP/Postal Code
75093
Country
United States
Facility Name
University of Utah Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Henrico Doctors' Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23229
Country
United States
Facility Name
Carilion Roanoke Memorial Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Medical College of Wisconsin
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban

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