Clinical TrialID 5541
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
NCT04142658
Aortic Valve Disease|Aortic Valve Stenosis|Aortic Valve Failure
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Record Fields
Scalar fields from the final clinical_trial record.
- Clinical Trial Id
- 5541
- Evidence Id
- 5541
- Core Evidence Id
- 5541
- Source Clinical Trial Id
- 5523
- Herb2 Clinical Trial Id
- HBCT005523
- Nct Id
- NCT04142658
- Title
- PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
- Status
- Terminated
- Phase
- Phase 3
- Study Result
- Yes
- Study Condition
- Aortic Valve Disease|Aortic Valve Stenosis|Aortic Valve Failure
- Study Type
- Interventional
- Study Design
- Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
- Intervention
- DRUG: Apixaban 5 MG|DRUG: Apixaban 2.5 MG|DRUG: Warfarin|DEVICE: On-X Aortic Mechanical Valve
- Intervention Allocation
- Randomized
- Intervention Model
- Parallel
- Intervention Mask
- Intervention Purpose
- Treatment
- Gender
- All
- Age
- Adult, Older_Adult
- Enrollment
- 863
- Outcome Measure
- Composite of Valve Thrombosis and Valve-related Thromboembolism, Valve thrombosis was defined as any thrombus, not caused by infection, attached to or near an implanted On-X valve that occluded part of the blood-flow path, interfered with valve function, or was sufficiently large to warrant treatment other than continued oral anticoagulation. Valve-related thromboembolism was defined as any thromboembolic stroke, transient ischemic attack, myocardial infarction, or arterial thromboembolism to an organ or limb that was not associated with infection or an intracardiac tumor and was definitely or possibly related to the valve., through study closure, a median follow-up of 13.5 months|Major Bleeding, Major bleeding defined as any episode of internal or external bleeding that caused death, hospitalization, or permanent injury or necessitated transfusion, pericardiocentesis, or reoperation., through study closure, a median follow-up of 13.5 months
- Sponsor Collaborator
- Artivion Inc.|Duke Clinical Research Institute
- Funded By
- INDUSTRY
- Location
- Tucson Heart Center, Tucson, Arizona, 85712, United States|CHI St. Vincent Heart Institute, Little Rock, Arkansas, 72205, United States|Loma Linda University Medical Center, Loma Linda, California, 92354, United States|Stanford University Medical Center, Palo Alto, California, 94305, United States|Sharp Memorial, San Diego, California, 92123, United States|Hartford Hospital, Hartford, Connecticut, 06102, United States|Yale- New Haven Hospital, New Haven, Connecticut, 06510, United States|Baycare Health / Morton Plant Hospital, Clearwater, Florida, 33756, United States|Shands Hospital (University of Florida Health), Gainesville, Florida, 32608, United States|AdventHealth Orlando, Orlando, Florida, 32803, United States|Tallahassee Research Institute, Tallahassee, Florida, 32308, United States|University of South Florida, Tampa, Florida, 33606, United States|Piedmont Atlanta Hospital, Atlanta, Georgia, 30309, United States|Emory University Hospital, Atlanta, Georgia, 30332, United States|Northeast Georgia Medical Center, Gainesville, Georgia, 30501, United States|Wellstar Kennestone Hospital, Marietta, Georgia, 30060, United States|Northwestern Memorial Hospital, Chicago, Illinois, 60611, United States|OSF Cardiovascular Institute, Rockford, Illinois, 61107, United States|Indiana University Health Methodist Hospital, Indianapolis, Indiana, 46202, United States|Franciscan Health Indianapolis, Indianapolis, Indiana, 46237, United States|University of Iowa, Iowa City, Iowa, 52242, United States|Maine Medical Center, Portland, Maine, 04102, United States|John's Hopkins University, Baltimore, Maryland, 21218, United States|Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States|Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States|University of Michigan Health, Ann Arbor, Michigan, 48109, United States|Abbott Northwestern Hospital, Minneapolis, Minnesota, 55407, United States|University of Minnesota, Minneapolis, Minnesota, 55422, United States|Mayo Clinic Rochester, Rochester, Minnesota, 55902, United States|Saint Luke's Hospital, Kansas City, Missouri, 64111, United States|Washington University Medical Center, Saint Louis, Missouri, 63105, United States|Missouri Baptist Medical Center, Saint Louis, Missouri, 63131, United States|University of Nebraska Medical Center, Omaha, Nebraska, 68198, United States|Mount Sinai- St. Luke's Hospital, New York, New York, 10029, United States|NewYork-Presbyterian Hospital, New York, New York, 10065, United States|NewYork-Presbyterian/ Weill Cornell Medical Center, New York, New York, 10065, United States|Vassar Brothers Medical Center, Poughkeepsie, New York, 12601, United States|University of Rochester Medical Center, Rochester, New York, 14642, United States|Atrium Health Carolinas Medical Center (CMC), Charlotte, North Carolina, 28203, United States|Duke University, Durham, North Carolina, 27708, United States|Cleveland Clinic, Cleveland, Ohio, 44195, United States|ProMedica Toledo Hospital, Toledo, Ohio, 43606, United States|Oklahoma Heart Hospital, Oklahoma City, Oklahoma, 73120, United States|Lehigh Valley Hospital Allentown, Allentown, Pennsylvania, 18103, United States|Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, 17033, United States|Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, 19104, United States|Thomas Jefferson University, Philadelphia, Pennsylvania, 19107, United States|UPMC Shadyside, Pittsburgh, Pennsylvania, 15232, United States|Avera Health / North Central Heart, Sioux Falls, South Dakota, 57108, United States|Tristar Centennial Medical Center, Nashville, Tennessee, 37203, United States|William P. Clements Jr. University Hospital, Dallas, Texas, 75235, United States|TCU School of Medicine, Fort Worth, Texas, 76107, United States|The University of Texas Health Science Center at Houston, Houston, Texas, 77030, United States|The Heart Hospital at Baylor Plano, Plano, Texas, 75093, United States|University of Utah Hospital, Salt Lake City, Utah, 84132, United States|Henrico Doctors' Hospital, Richmond, Virginia, 23229, United States|Carilion Roanoke Memorial Hospital, Roanoke, Virginia, 24014, United States|Swedish Medical Center, Seattle, Washington, 98122, United States|University of Washington Medical Center, Seattle, Washington, 98195, United States|Tacoma General Hospital, Tacoma, Washington, 98405, United States|University of Wisconsin, Madison, Wisconsin, 53792, United States|Medical College of Wisconsin, Wauwatosa, Wisconsin, 53226, United States
- Other Id
- ONX1801.000-C
- Start Date
- 2020-05-01
- Primary Completion Date
- 2022-12-12
- Completion Date
- 2022-12-12
- First Posted
- 2019-10-29
- Results First Posted
- 2024-03-20
- Last Update Posted
- 2024-03-20
- Study Document
- Study Protocol and Statistical Analysis Plan, https://cdn.clinicaltrials.gov/large-docs/58/NCT04142658/Prot_SAP_000.pdf
- Study Url
- https://clinicaltrials.gov/study/NCT04142658
- Title Cn
- Title En
- PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
- Bilingual Status
- semi_complete