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

PHASE3TerminatedINTERVENTIONAL
Enrollment

863

Participants

Timeline

Start Date

May 1, 2020

Primary Completion Date

December 12, 2022

Study Completion Date

December 12, 2022

Conditions
Aortic Valve DiseaseAortic Valve StenosisAortic Valve Failure
Interventions
DRUG

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)"

DRUG

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)"

DRUG

Warfarin

Active Control Intervention

DEVICE

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.

Trial Locations (62)

10029

Mount Sinai- St. Luke's Hospital, New York

10065

NewYork-Presbyterian Hospital, New York

NewYork-Presbyterian/ Weill Cornell Medical Center, New York

12601

Vassar Brothers Medical Center, Poughkeepsie

14642

University of Rochester Medical Center, Rochester

15232

UPMC Shadyside, Pittsburgh

17033

Penn State Health Milton S. Hershey Medical Center, Hershey

18103

Lehigh Valley Hospital Allentown, Allentown

19104

Hospital of the University of Pennsylvania, Philadelphia

19107

Thomas Jefferson University, Philadelphia

21218

John's Hopkins University, Baltimore

23229

Henrico Doctors' Hospital, Richmond

24014

Carilion Roanoke Memorial Hospital, Roanoke

27708

Duke University, Durham

28203

Atrium Health Carolinas Medical Center (CMC), Charlotte

30060

Wellstar Kennestone Hospital, Marietta

30309

Piedmont Atlanta Hospital, Atlanta

30332

Emory University Hospital, Atlanta

30501

Northeast Georgia Medical Center, Gainesville

32308

Tallahassee Research Institute, Tallahassee

32608

Shands Hospital (University of Florida Health), Gainesville

32803

AdventHealth Orlando, Orlando

33606

University of South Florida, Tampa

33756

Baycare Health / Morton Plant Hospital, Clearwater

37203

Tristar Centennial Medical Center, Nashville

43606

ProMedica Toledo Hospital, Toledo

44195

Cleveland Clinic, Cleveland

46202

Indiana University Health Methodist Hospital, Indianapolis

46237

Franciscan Health Indianapolis, Indianapolis

48109

University of Michigan Health, Ann Arbor

52242

University of Iowa, Iowa City

53226

Medical College of Wisconsin, Wauwatosa

53792

University of Wisconsin, Madison

55407

Abbott Northwestern Hospital, Minneapolis

55422

University of Minnesota, Minneapolis

55902

Mayo Clinic Rochester, Rochester

57108

Avera Health / North Central Heart, Sioux Falls

60611

Northwestern Memorial Hospital, Chicago

61107

OSF Cardiovascular Institute, Rockford

63105

Washington University Medical Center, St Louis

63131

Missouri Baptist Medical Center, St Louis

64111

Saint Luke's Hospital, Kansas City

68198

University of Nebraska Medical Center, Omaha

72205

CHI St. Vincent Heart Institute, Little Rock

73120

Oklahoma Heart Hospital, Oklahoma City

75093

The Heart Hospital at Baylor Plano, Plano

75235

William P. Clements Jr. University Hospital, Dallas

76107

TCU School of Medicine, Fort Worth

77030

The University of Texas Health Science Center at Houston, Houston

84132

University of Utah Hospital, Salt Lake City

85712

Tucson Heart Center, Tucson

92123

Sharp Memorial, San Diego

92354

Loma Linda University Medical Center, Loma Linda

94305

Stanford University Medical Center, Palo Alto

98122

Swedish Medical Center, Seattle

98195

University of Washington Medical Center, Seattle

98405

Tacoma General Hospital, Tacoma

06102

Hartford Hospital, Hartford

06510

Yale- New Haven Hospital, New Haven

04102

Maine Medical Center, Portland

02115

Brigham and Women's Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

Sponsors
All Listed Sponsors
collaborator

Duke Clinical Research Institute

OTHER

lead

Artivion Inc.

INDUSTRY

NCT04142658 - PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban | Biotech Hunter | Biotech Hunter