PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Public ClinicalTrials.gov record NCT04142658. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04142658
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 863 participants
Conditions and interventions
Interventions
- Apixaban 5 MG Drug
- Apixaban 2.5 MG Drug
- Warfarin Drug
- On-X Aortic Mechanical Valve Device
Drug · Device
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 1, 2020 (Actual)
- Primary completion
- Dec 12, 2022 (Actual)
- Completion
- Dec 12, 2022 (Actual)
- Last update posted
- Mar 20, 2024
2020 – 2022
United States locations
- U.S. sites
- 62
- U.S. states
- 28
- U.S. cities
- 53
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Tucson Heart Center | Tucson | Arizona | 85712 | — |
| CHI St. Vincent Heart Institute | Little Rock | Arkansas | 72205 | — |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | — |
| Stanford University Medical Center | Palo Alto | California | 94305 | — |
| Sharp Memorial | San Diego | California | 92123 | — |
| Hartford Hospital | Hartford | Connecticut | 06102 | — |
| Yale- New Haven Hospital | New Haven | Connecticut | 06510 | — |
| Baycare Health / Morton Plant Hospital | Clearwater | Florida | 33756 | — |
| Shands Hospital (University of Florida Health) | Gainesville | Florida | 32608 | — |
| AdventHealth Orlando | Orlando | Florida | 32803 | — |
| Tallahassee Research Institute | Tallahassee | Florida | 32308 | — |
| University of South Florida | Tampa | Florida | 33606 | — |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | — |
| Emory University Hospital | Atlanta | Georgia | 30332 | — |
| Northeast Georgia Medical Center | Gainesville | Georgia | 30501 | — |
| Wellstar Kennestone Hospital | Marietta | Georgia | 30060 | — |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | — |
| OSF Cardiovascular Institute | Rockford | Illinois | 61107 | — |
| Indiana University Health Methodist Hospital | Indianapolis | Indiana | 46202 | — |
| Franciscan Health Indianapolis | Indianapolis | Indiana | 46237 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| Maine Medical Center | Portland | Maine | 04102 | — |
| John's Hopkins University | Baltimore | Maryland | 21218 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| University of Michigan Health | Ann Arbor | Michigan | 48109 | — |
| Abbott Northwestern Hospital | Minneapolis | Minnesota | 55407 | — |
| University of Minnesota | Minneapolis | Minnesota | 55422 | — |
| Mayo Clinic Rochester | Rochester | Minnesota | 55902 | — |
| Saint Luke's Hospital | Kansas City | Missouri | 64111 | — |
| Washington University Medical Center | St Louis | Missouri | 63105 | — |
| Missouri Baptist Medical Center | St Louis | Missouri | 63131 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| Mount Sinai- St. Luke's Hospital | New York | New York | 10029 | — |
| NewYork-Presbyterian Hospital | New York | New York | 10065 | — |
| NewYork-Presbyterian/ Weill Cornell Medical Center | New York | New York | 10065 | — |
| Vassar Brothers Medical Center | Poughkeepsie | New York | 12601 | — |
| University of Rochester Medical Center | Rochester | New York | 14642 | — |
| Atrium Health Carolinas Medical Center (CMC) | Charlotte | North Carolina | 28203 | — |
| Duke University | Durham | North Carolina | 27708 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| ProMedica Toledo Hospital | Toledo | Ohio | 43606 | — |
| Oklahoma Heart Hospital | Oklahoma City | Oklahoma | 73120 | — |
| Lehigh Valley Hospital Allentown | Allentown | Pennsylvania | 18103 | — |
| Penn State Health Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| UPMC Shadyside | Pittsburgh | Pennsylvania | 15232 | — |
| Avera Health / North Central Heart | Sioux Falls | South Dakota | 57108 | — |
| Tristar Centennial Medical Center | Nashville | Tennessee | 37203 | — |
| William P. Clements Jr. University Hospital | Dallas | Texas | 75235 | — |
| TCU School of Medicine | Fort Worth | Texas | 76107 | — |
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | — |
| The Heart Hospital at Baylor Plano | Plano | Texas | 75093 | — |
| University of Utah Hospital | Salt Lake City | Utah | 84132 | — |
| Henrico Doctors' Hospital | Richmond | Virginia | 23229 | — |
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| University of Washington Medical Center | Seattle | Washington | 98195 | — |
| Tacoma General Hospital | Tacoma | Washington | 98405 | — |
| University of Wisconsin | Madison | Wisconsin | 53792 | — |
| Medical College of Wisconsin | Wauwatosa | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04142658, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 20, 2024 · Synced Oct 24, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04142658 live on ClinicalTrials.gov.