PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
NCT ID: NCT04142658
Last Updated: 2024-03-20
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
863 participants
INTERVENTIONAL
2020-05-01
2022-12-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apixaban
Apixaban 5 mg twice daily(BID) or 2.5 mg BID
Apixaban 5 MG
For patients that do NOT meet the following criteria
* age ≥ 80 years
* weight ≤ 60 kilograms
* creatinine ≥ 1.5 mg/dL (133 micromol/L)
Apixaban 2.5 MG
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)
On-X Aortic Mechanical Valve
Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
Warfarin
Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)
Warfarin
Active Control Intervention
On-X Aortic Mechanical Valve
Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
Interventions
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Apixaban 5 MG
For patients that do NOT meet the following criteria
* age ≥ 80 years
* weight ≤ 60 kilograms
* creatinine ≥ 1.5 mg/dL (133 micromol/L)
Apixaban 2.5 MG
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)
Warfarin
Active Control Intervention
On-X Aortic Mechanical Valve
Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Duke Clinical Research Institute
OTHER
Artivion Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Lars Svensson, MD, PhD
Role: STUDY_CHAIR
Steering Committee
John Alexander, MD
Role: STUDY_CHAIR
Steering Committee
Locations
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Tucson Heart Center
Tucson, Arizona, United States
CHI St. Vincent Heart Institute
Little Rock, Arkansas, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Sharp Memorial
San Diego, California, United States
Hartford Hospital
Hartford, Connecticut, United States
Yale- New Haven Hospital
New Haven, Connecticut, United States
Baycare Health / Morton Plant Hospital
Clearwater, Florida, United States
Shands Hospital (University of Florida Health)
Gainesville, Florida, United States
AdventHealth Orlando
Orlando, Florida, United States
Tallahassee Research Institute
Tallahassee, Florida, United States
University of South Florida
Tampa, Florida, United States
Piedmont Atlanta Hospital
Atlanta, Georgia, United States
Emory University Hospital
Atlanta, Georgia, United States
Northeast Georgia Medical Center
Gainesville, Georgia, United States
Wellstar Kennestone Hospital
Marietta, Georgia, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
OSF Cardiovascular Institute
Rockford, Illinois, United States
Indiana University Health Methodist Hospital
Indianapolis, Indiana, United States
Franciscan Health Indianapolis
Indianapolis, Indiana, United States
University of Iowa
Iowa City, Iowa, United States
Maine Medical Center
Portland, Maine, United States
John's Hopkins University
Baltimore, Maryland, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan Health
Ann Arbor, Michigan, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Saint Luke's Hospital
Kansas City, Missouri, United States
Washington University Medical Center
St Louis, Missouri, United States
Missouri Baptist Medical Center
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Mount Sinai- St. Luke's Hospital
New York, New York, United States
NewYork-Presbyterian Hospital
New York, New York, United States
NewYork-Presbyterian/ Weill Cornell Medical Center
New York, New York, United States
Vassar Brothers Medical Center
Poughkeepsie, New York, United States
University of Rochester Medical Center
Rochester, New York, United States
Atrium Health Carolinas Medical Center (CMC)
Charlotte, North Carolina, United States
Duke University
Durham, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
ProMedica Toledo Hospital
Toledo, Ohio, United States
Oklahoma Heart Hospital
Oklahoma City, Oklahoma, United States
Lehigh Valley Hospital Allentown
Allentown, Pennsylvania, United States
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, United States
UPMC Shadyside
Pittsburgh, Pennsylvania, United States
Avera Health / North Central Heart
Sioux Falls, South Dakota, United States
Tristar Centennial Medical Center
Nashville, Tennessee, United States
William P. Clements Jr. University Hospital
Dallas, Texas, United States
TCU School of Medicine
Fort Worth, Texas, United States
The University of Texas Health Science Center at Houston
Houston, Texas, United States
The Heart Hospital at Baylor Plano
Plano, Texas, United States
University of Utah Hospital
Salt Lake City, Utah, United States
Henrico Doctors' Hospital
Richmond, Virginia, United States
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States
Swedish Medical Center
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
Tacoma General Hospital
Tacoma, Washington, United States
University of Wisconsin
Madison, Wisconsin, United States
Medical College of Wisconsin
Wauwatosa, Wisconsin, United States
Countries
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References
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Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002. No abstract available.
Bourguignon T, Lhommet P, El Khoury R, Candolfi P, Loardi C, Mirza A, Boulanger-Lothion J, Bouquiaux-Stablo-Duncan AL, Marchand M, Aupart M. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years. Eur J Cardiothorac Surg. 2016 May;49(5):1462-8. doi: 10.1093/ejcts/ezv384. Epub 2015 Nov 2.
Chambers JB, Pomar JL, Mestres CA, Palatianos GM. Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years. J Thorac Cardiovasc Surg. 2013 Feb;145(2):420-4. doi: 10.1016/j.jtcvs.2011.12.059. Epub 2012 Feb 17.
Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.
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Goldstone AB, Chiu P, Baiocchi M, Lingala B, Patrick WL, Fischbein MP, Woo YJ. Mechanical or Biologic Prostheses for Aortic-Valve and Mitral-Valve Replacement. N Engl J Med. 2017 Nov 9;377(19):1847-1857. doi: 10.1056/NEJMoa1613792.
Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.
Head SJ, Mylotte D, Mack MJ, Piazza N, van Mieghem NM, Leon MB, Kappetein AP, Holmes DR Jr. Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval. Circulation. 2016 May 24;133(21):2086-93. doi: 10.1161/CIRCULATIONAHA.115.020493.
Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017 Jul 21;38(28):2183-2191. doi: 10.1093/eurheartj/ehx141.
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Lester PA, Coleman DM, Diaz JA, Jackson TO, Hawley AE, Mathues AR, Grant BT, Knabb RM, Ramacciotti E, Frost CE, Song Y, Wakefield TW, Myers DD Jr. Apixaban Versus Warfarin for Mechanical Heart Valve Thromboprophylaxis in a Swine Aortic Heterotopic Valve Model. Arterioscler Thromb Vasc Biol. 2017 May;37(5):942-948. doi: 10.1161/ATVBAHA.116.308649. Epub 2017 Feb 23.
McNicholas KW, Ivey TD, Metras J, Szentpetery S, Marra SW, Masters RG, Dilling EW, Slaughter MS, Mack MJ. North American multicenter experience with the On-X prosthetic heart valve. J Heart Valve Dis. 2006 Jan;15(1):73-8; discussion 79.
Palatianos GM, Laczkovics AM, Simon P, Pomar JL, Birnbaum DE, Greve HH, Haverich A. Multicentered European study on safety and effectiveness of the On-X prosthetic heart valve: intermediate follow-up. Ann Thorac Surg. 2007 Jan;83(1):40-6. doi: 10.1016/j.athoracsur.2006.08.010.
Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A; PROACT Investigators. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.
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Tossios P, Reber D, Oustria M, Holland-Letz T, Germing A, Buchwald D, Laczkovics A. Single-center experience with the On-X prosthetic heart valve between 1996 and 2005. J Heart Valve Dis. 2007 Sep;16(5):551-7.
Williams MA, van Riet S. The On-X heart valve: mid-term results in a poorly anticoagulated population. J Heart Valve Dis. 2006 Jan;15(1):80-6.
Wu Y, Butchart EG, Borer JS, Yoganathan A, Grunkemeier GL. Clinical evaluation of new heart valve prostheses: update of objective performance criteria. Ann Thorac Surg. 2014 Nov;98(5):1865-74. doi: 10.1016/j.athoracsur.2014.05.006. Epub 2014 Sep 23.
Jawitz OK, Wang TY, Lopes RD, Chavez A, Boyer B, Kim H, Anstrom KJ, Becker RC, Blackstone E, Ruel M, Thourani VH, Puskas JD, Gerdisch MW, Johnston D, Capps S, Alexander JH, Svensson LG. Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve. Am Heart J. 2020 Sep;227:91-99. doi: 10.1016/j.ahj.2020.06.014. Epub 2020 Jun 25.
Wang TY, Svensson LG, Wen J, Vekstein A, Gerdisch M, Rao VU, Moront M, Johnston D, Lopes RD, Chavez A, Ruel M, Blackstone EH, Becker RC, Thourani V, Puskas J, Al-Khalidi HR, Cable DG, Elefteriades JA, Pochettino A, Wolfe JA, Graeve A, Sultan I, Sabe AA, Michelena HI, Alexander JH. Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve. NEJM Evid. 2023 Jul;2(7):EVIDoa2300067. doi: 10.1056/EVIDoa2300067. Epub 2023 May 6.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ONX1801.000-C
Identifier Type: -
Identifier Source: org_study_id
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