Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness

Last updated: December 7, 2015
Sponsor: Bristol-Myers Squibb
Overall Status: Completed

Phase

3

Condition

Lung Disease

Lung Injury

Venous Thrombosis

Treatment

N/A

Clinical Study ID

NCT00457002
CV185-036
  • Ages > 40
  • All Genders

Study Summary

The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis [DVT]) and lung (pulmonary embolism [PE]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • men and non-pregnant, non-breastfeeding women

  • 40 years or older

  • hospitalized with congestive heart failure or acute respiratory failure

  • infection (without septic shock)

  • acute rheumatic disorder

  • inflammatory bowel disease

Exclusion

Exclusion Criteria:

  • patients with venous thromboembolism (VTE)

  • active bleeding or at high risk of bleeding

  • unable to take oral medication

  • with diseases requiring ongoing treatment with anticoagulants or antiplatelets otherthan aspirin at a dose ≤ 165 mg/day.

Study Design

Total Participants: 6758
Study Start date:
June 01, 2007
Estimated Completion Date:
May 31, 2011

Connect with a study center

  • Local Institution

    Ciudad Autonoma Buenos Aires, Buenos Aires C1280AEB
    Argentina

    Site Not Available

  • Local Institution

    Coronel Suarez, Buenos Aires B7540GHD
    Argentina

    Site Not Available

  • Local Institution

    Derqui-Pilar, Buenos Aires B1629ODT
    Argentina

    Site Not Available

  • Local Institution

    La Plata, Buenos Aires 1900
    Argentina

    Site Not Available

  • Local Institution

    Munro, Buenos Aires B1605DSX
    Argentina

    Site Not Available

  • Local Institution

    San Martin, Buenos Aires B1650CSQ
    Argentina

    Site Not Available

  • Local Institution

    Rosario, Santa Fe 2000
    Argentina

    Site Not Available

  • Local Institution

    San Miguel De Tucuman, Tucuman T4000JCU
    Argentina

    Site Not Available

  • Local Institution

    Buenos Aires, C1181ACH
    Argentina

    Site Not Available

  • Local Institution

    Cordoba, 5000
    Argentina

    Site Not Available

  • Local Institution

    Corrientes, 3400
    Argentina

    Site Not Available

  • Local Institution

    Concord, New South Wales 2139
    Australia

    Site Not Available

  • Local Institution

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Local Institution

    Kippa Ring, Queensland 4021
    Australia

    Site Not Available

  • Local Institution

    Woolloongabba, Queensland 4102
    Australia

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    Bedford Park, South Australia 5042
    Australia

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  • Local Institution

    Woodville, South Australia 5011
    Australia

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  • Local Institution

    Box Hill, Victoria 3128
    Australia

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  • Local Institution

    Parkville, Victoria 3050
    Australia

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  • Local Institution

    Ringwood East, Victoria 3135
    Australia

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  • Local Institution

    Graz, 8036
    Austria

    Site Not Available

  • Local Institution

    Wien, 1090
    Austria

    Site Not Available

  • Local Institution

    Ottignies, Waals-Brabant 1340
    Belgium

    Site Not Available

  • Local Institution

    Antwerpen, 2060
    Belgium

    Site Not Available

  • Local Institution

    Brasschaat, 2930
    Belgium

    Site Not Available

  • Local Institution

    Bruxelles, 1070
    Belgium

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  • Local Institution

    Huy, 4500
    Belgium

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  • Local Institution

    Leuven, 3000
    Belgium

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  • Local Institution

    Belo Horizonte, Minas Gerais 30150
    Brazil

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    Curitiba, Parana 80810
    Brazil

    Site Not Available

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    Porto Alegre, Rio Grande Do Sul 91430
    Brazil

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  • Local Institution

    Botucatu, Sao Paulo 18618
    Brazil

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    Campinas, Sao Paulo 13059
    Brazil

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    Sao Jose Do Rio Preto, Sao Paulo 15091
    Brazil

    Site Not Available

  • Local Institution

    Sao Paulo, 05403
    Brazil

    Site Not Available

  • Local Institution

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

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    Hamilton, Ontario L8N 4A6
    Canada

    Site Not Available

  • Local Institution

    Windsor, Ontario N8X 5A6
    Canada

    Site Not Available

  • Local Institution

    Granby, Quebec J2G 1T7
    Canada

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  • Local Institution

    Greenfield Park, Quebec J4V 2H1
    Canada

    Site Not Available

  • Local Institution

    Montreal, Quebec H3T 1E2
    Canada

    Site Not Available

  • Local Institution

    Temuco, Araucania - - - - -
    Chile

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  • Local Institution

    Santiago, Metropolitana 8207257
    Chile

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  • Local Institution

    Rancagua, Valparaiso
    Chile

    Site Not Available

  • Local Institution

    Bogota,
    Colombia

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    Bucaramanga,
    Colombia

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  • Local Institution

    Medellin,
    Colombia

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  • Local Institution

    Brno, 656 91
    Czech Republic

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  • Local Institution

    Jindrichuv Hradec, 377 38
    Czech Republic

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  • Local Institution

    Kladno, 272 59
    Czech Republic

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  • Local Institution

    Kyjov, 697 01
    Czech Republic

    Site Not Available

  • Local Institution

    Ostrava, 728 80
    Czech Republic

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  • Local Institution

    Prague 2, 128 08
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 1, 110 00
    Czech Republic

    Site Not Available

  • Local Institution

    Praha 5, 150 06
    Czech Republic

    Site Not Available

  • Local Institution

    Usti Nad Labem, 401 13
    Czech Republic

    Site Not Available

  • Local Institution

    Aalborg, 9100
    Denmark

    Site Not Available

  • Local Institution

    Aarhus N, 8200
    Denmark

    Site Not Available

  • Local Institution

    Arhus C, 8000
    Denmark

    Site Not Available

  • Local Institution

    Frederiksberg, 2000
    Denmark

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  • Local Institution

    Glostrup, 2600
    Denmark

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  • Local Institution

    Hellerup, 2900
    Denmark

    Site Not Available

  • Local Institution

    Herlev, 2730
    Denmark

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  • Local Institution

    Herning, 7400
    Denmark

    Site Not Available

  • Local Institution

    Hvidovre, 2650
    Denmark

    Site Not Available

  • Local Institution

    Odense, 5000
    Denmark

    Site Not Available

  • Local Institution

    Randers No, 8930
    Denmark

    Site Not Available

  • Local Institution

    Silkeborg, 8600
    Denmark

    Site Not Available

  • Local Institution

    Bordeaux, 33075
    France

    Site Not Available

  • Local Institution

    Brest, 29200
    France

    Site Not Available

  • Local Institution

    Brest Cedex, 29609
    France

    Site Not Available

  • Local Institution

    Dijon Cedex, 21079
    France

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    Grenoble Cedex 9, 38043
    France

    Site Not Available

  • Local Institution

    Lille Cedex, 59020
    France

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  • Local Institution

    Nancy, 54035
    France

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    Nimes Cedex 9, 30029
    France

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    Paris Cedex 10, 75475
    France

    Site Not Available

  • Local Institution

    Paris Cedex 15, 75908
    France

    Site Not Available

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    Saint Etienne Cedex 02, 42055
    France

    Site Not Available

  • Local Institution

    Vernon, 27207
    France

    Site Not Available

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    Bonn, 53127
    Germany

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    Coburg, 96450
    Germany

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    Darmstadt, 64283
    Germany

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    Dresden, 01099
    Germany

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    Hannover, 30625
    Germany

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    Karlsbad, 76307
    Germany

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    Luebeck, 23538
    Germany

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  • Local Institution

    Mannheim, 68167
    Germany

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    Offenbach, 63069
    Germany

    Site Not Available

  • Local Institution

    Witten, 58455
    Germany

    Site Not Available

  • Local Institution

    Shatin, N.T.,
    Hong Kong

    Site Not Available

  • Local Institution

    Budapest, 1135
    Hungary

    Site Not Available

  • Local Institution

    Debrecen, 4032
    Hungary

    Site Not Available

  • Local Institution

    Dunaujvaros, 2400
    Hungary

    Site Not Available

  • Local Institution

    Eger, 3300
    Hungary

    Site Not Available

  • Local Institution

    Vishakapatnam, Andhra-Pradesh 530002
    India

    Site Not Available

  • Local Institution

    Ahemdabad, Gujarat 380054
    India

    Site Not Available

  • Local Institution

    Indore, Madhya Pardesh 452018
    India

    Site Not Available

  • Local Institution

    Pune, Maharastra 411001
    India

    Site Not Available

  • Local Institution

    Ludhiana, Punjab 141001
    India

    Site Not Available

  • Local Institution

    Coimbatore, Tamil Nadu 641004
    India

    Site Not Available

  • Local Institution

    Madurai, Tamil Nadu 625107
    India

    Site Not Available

  • Local Institution

    Chennai, Tamil-Nadu 600096
    India

    Site Not Available

  • Local Institution

    Noida, Uttar Pradesh 201301
    India

    Site Not Available

  • Local Institution

    Ahmedabad, 380054
    India

    Site Not Available

  • Local Institution

    Bangalore, 560054
    India

    Site Not Available

  • Local Institution

    Hyderabad, 500033
    India

    Site Not Available

  • Local Institution

    Mumbai, 400008
    India

    Site Not Available

  • Local Institution

    New Delhi, 110025
    India

    Site Not Available

  • Local Institution

    Afula, 18101
    Israel

    Site Not Available

  • Local Institution

    Ashkelon, 78308
    Israel

    Site Not Available

  • Local Institution

    Beer Sheva, 84105
    Israel

    Site Not Available

  • Local Institution

    Haifa, 31096
    Israel

    Site Not Available

  • Local Institution

    Petach Tikva, 49100
    Israel

    Site Not Available

  • Local Institution

    Safed, 13110
    Israel

    Site Not Available

  • Local Institution

    Tel Hashomer, 52621
    Israel

    Site Not Available

  • Local Institution

    Tel-Aviv, 64239
    Israel

    Site Not Available

  • Local Institution

    Zerifin, 70300
    Israel

    Site Not Available

  • Local Institution

    Chieti Scalo, 66013
    Italy

    Site Not Available

  • Local Institution

    Cremona, 26100
    Italy

    Site Not Available

  • Local Institution

    Padua, 35128
    Italy

    Site Not Available

  • Local Institution

    Piacenza, 29100
    Italy

    Site Not Available

  • Local Institution

    Reggio Emilia, 42100
    Italy

    Site Not Available

  • Local Institution

    Treviso, 31100
    Italy

    Site Not Available

  • Local Institution

    Vicenza, 36100
    Italy

    Site Not Available

  • Local Institution

    Guri-Si, Gyeonggi-Do 471-701
    Korea, Republic of

    Site Not Available

  • Local Institution

    Seongnam-Si, Gyeonggi-Do 463-707
    Korea, Republic of

    Site Not Available

  • Local Institution

    Seoul, 120-752
    Korea, Republic of

    Site Not Available

  • Local Institution

    Suwon, 443721
    Korea, Republic of

    Site Not Available

  • Local Institution

    Kubang Kerian, Kelantan 16150
    Malaysia

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  • Local Institution

    Batu Caves, Selangor 68100
    Malaysia

    Site Not Available

  • Local Institution

    Johor Bahru, 80100
    Malaysia

    Site Not Available

  • Local Institution

    Mexico, Distrito Federal 06726
    Mexico

    Site Not Available

  • Local Institution

    Monterrey, Nuevo Leon 64460
    Mexico

    Site Not Available

  • Local Institution

    Xalapa, Veracruz 91020
    Mexico

    Site Not Available

  • Local Institution

    Merida, Yucatan 97129
    Mexico

    Site Not Available

  • Local Institution

    Queretaro, 76178
    Mexico

    Site Not Available

  • Local Institution

    San Luis Potosi, 78220
    Mexico

    Site Not Available

  • Local Institution

    Den Helder, 1782 GZ
    Netherlands

    Site Not Available

  • Local Institution

    Kongsvinger, 2226
    Norway

    Site Not Available

  • Local Institution

    La Victoria, Lima LIMA 13
    Peru

    Site Not Available

  • Local Institution

    Arequipa, AREQUIPA54
    Peru

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  • Local Institution

    Callao, CALLAO 2
    Peru

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  • Local Institution

    Lima, LIMA 1
    Peru

    Site Not Available

  • Local Institution

    Cagayan De Oro City, Misamis Oriental 9000
    Philippines

    Site Not Available

  • Local Institution

    Las Pinas, 1742
    Philippines

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  • Local Institution

    Quezon City, 1100
    Philippines

    Site Not Available

  • Local Institution

    Bydgoszcz, 85-168
    Poland

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  • Local Institution

    Krakow, 31-202
    Poland

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  • Local Institution

    Lodz, 91-347
    Poland

    Site Not Available

  • Local Institution

    Nowa Sol, 67-100
    Poland

    Site Not Available

  • Local Institution

    Poznan, 61-833
    Poland

    Site Not Available

  • Local Institution

    Skierniewice, 96-100
    Poland

    Site Not Available

  • Local Institution

    Warszawa, 03-737
    Poland

    Site Not Available

  • Local Institution

    Wejherowo, 84-200
    Poland

    Site Not Available

  • Local Institution

    Zielona Gora, 65-046
    Poland

    Site Not Available

  • Local Institution

    Moscow, 111539
    Russian Federation

    Site Not Available

  • Local Institution

    Odintsovo, 143000
    Russian Federation

    Site Not Available

  • Local Institution

    Podolsk, 142100
    Russian Federation

    Site Not Available

  • Local Institution

    Ryazan, 390005
    Russian Federation

    Site Not Available

  • Local Institution

    Saint Petersburg, 199106
    Russian Federation

    Site Not Available

  • Local Institution

    Saint-Petersburg, 198205
    Russian Federation

    Site Not Available

  • Local Institution

    Saratov, 410002
    Russian Federation

    Site Not Available

  • Local Institution

    St Petersburg, 195067
    Russian Federation

    Site Not Available

  • Local Institution

    St. Petersburg, 193312
    Russian Federation

    Site Not Available

  • Local Institution

    St.Petersburg, 192242
    Russian Federation

    Site Not Available

  • Local Institution

    Singapore, 308433
    Singapore

    Site Not Available

  • Local Institution

    Bloemfontein, Free State 9301
    South Africa

    Site Not Available

  • Local Institution

    Johannesburg, Gauteng 2193
    South Africa

    Site Not Available

  • Local Institution

    Pretoria, Gauteng 0044
    South Africa

    Site Not Available

  • Local Institution

    Amanzimtoti, Kwa Zulu Natal 4120
    South Africa

    Site Not Available

  • Local Institution

    Bellville, Western Cape 7530
    South Africa

    Site Not Available

  • Local Institution

    Groenkloof, 0181
    South Africa

    Site Not Available

  • Local Institution

    Torrevieja, Alicante 03186
    Spain

    Site Not Available

  • Local Institution

    Alcorcon(Madrid), 28922
    Spain

    Site Not Available

  • Local Institution

    Barcelona, 08003
    Spain

    Site Not Available

  • Local Institution

    Madrid, 28034
    Spain

    Site Not Available

  • Local Institution

    Sevilla, 41013
    Spain

    Site Not Available

  • Local Institution

    Tarragona, 43007
    Spain

    Site Not Available

  • Local Institution

    Goteborg, 413 45
    Sweden

    Site Not Available

  • Local Institution

    Lund, 221 85
    Sweden

    Site Not Available

  • Local Institution

    Yung-Kang City, Tainan 710
    Taiwan

    Site Not Available

  • Local Institution

    Taichung, 402
    Taiwan

    Site Not Available

  • Local Institution

    Istanbul, Capa 34390
    Turkey

    Site Not Available

  • Local Institution

    Ankara, Dikimevi 06100
    Turkey

    Site Not Available

  • Local Institution

    Donetsk, 83003
    Ukraine

    Site Not Available

  • Local Institution

    Kharkiv, 61176
    Ukraine

    Site Not Available

  • Local Institution

    Kharkov, 61039
    Ukraine

    Site Not Available

  • Local Institution

    Kyiv, 03115
    Ukraine

    Site Not Available

  • Local Institution

    Lutsk, 43024
    Ukraine

    Site Not Available

  • Local Institution

    Lviv, 79010
    Ukraine

    Site Not Available

  • Local Institution

    Uzhgorod, 88000
    Ukraine

    Site Not Available

  • Local Institution

    Vinnitsa, 21029
    Ukraine

    Site Not Available

  • Local Institution

    London, Greater London SW3 6LR
    United Kingdom

    Site Not Available

  • Local Institution

    Uxbridge, Middlesex UB8 3NN
    United Kingdom

    Site Not Available

  • Local Institution

    Newcastle, Tyne And Wear NE7 7DN
    United Kingdom

    Site Not Available

  • Local Institution

    Dudley, West Midlands DY1 2HQ
    United Kingdom

    Site Not Available

  • Local Institution

    Hull, Yorkshire HU3 2JZ
    United Kingdom

    Site Not Available

  • University Of Alabama At Birmingham Hospital

    Birmingham, Alabama 35294
    United States

    Site Not Available

  • Heart Center Research, Llc

    Huntsville, Alabama 35801
    United States

    Site Not Available

  • Arizona Pulmonary Specialists, Ltd.

    Phoenix, Arizona 85013
    United States

    Site Not Available

  • Az Pulmonary Specialists Ltd

    Scottsdale, Arizona 85258
    United States

    Site Not Available

  • Fort Smith Lung Center

    Fort Smith, Arkansas 72901
    United States

    Site Not Available

  • Scripps Clinic/Scripps Health And Green Hospital

    La Jolla, California 92037
    United States

    Site Not Available

  • Va Long Beach Healthcare System

    Long Beach, California 90822
    United States

    Site Not Available

  • Univ. Of Southern Calif. /Norris Comprehensive Cancer Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • Dr. Felt Medical Office

    Oakland, California 94609
    United States

    Site Not Available

  • Stanford University

    Stanford, California 94305
    United States

    Site Not Available

  • Yale University School Of Medicine

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Norwalk Hospital

    Norwalk, Connecticut 06856
    United States

    Site Not Available

  • George Washington University

    Washington, District of Columbia 20037
    United States

    Site Not Available

  • Florida Hospital Celebration Health

    Celebration, Florida 34747
    United States

    Site Not Available

  • Research Alliance, Inc.

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Jacksonville Center For Clinical Research

    Jacksonville, Florida 32216
    United States

    Site Not Available

  • Pensacola Lung Group

    Pensacola, Florida 32504
    United States

    Site Not Available

  • Indian River Med. Ctr.

    Vero Beach, Florida 32960
    United States

    Site Not Available

  • Atlanta Institute For Medical Research, Inc

    Atlanta, Georgia 30030
    United States

    Site Not Available

  • Pulmonary & Critical Care Of Atlanta

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Idaho Falls Infectious Diseases, Pllc

    Idaho Falls, Idaho 83404
    United States

    Site Not Available

  • West Suburban Hospital

    Oak Park, Illinois 60302
    United States

    Site Not Available

  • Infectious Disease Of Indiana Psc

    Carmel, Indiana 46032
    United States

    Site Not Available

  • Cotton-O-Neil Clinical Research Center

    Topeka, Kansas 66604
    United States

    Site Not Available

  • Louisiana State University Health Sciences Center-Shreveport

    Shreveport, Louisiana 71103
    United States

    Site Not Available

  • Franklin Square Hospital

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Johns Hopkins University School Of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Henry Ford Hospital, Transplant Institute

    Detriot, Michigan 48202
    United States

    Site Not Available

  • University Of Missouri-Columbia

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Mercury Street Medical Group, Pllc

    Butte, Montana 59701
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Morristown Memorial Hospital

    Mornstown, New Jersey 07962
    United States

    Site Not Available

  • North Shore University Hospital

    Manhasset, New York 11030
    United States

    Site Not Available

  • Staten Island University Hospital

    Staten Island, New York 10305
    United States

    Site Not Available

  • Mission Hospital, Inc

    Asheville, North Carolina 28801
    United States

    Site Not Available

  • South Oklahoma Heart Research

    Oklahoma City, Oklahoma 73135
    United States

    Site Not Available

  • Lehigh Valley Hospital

    Allentown, Pennsylvania 18103
    United States

    Site Not Available

  • The Milton S Hershey Medical Center Of Penn. State Univ.

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Thomas Jefferson University

    Philadelphia, Pennsylvania 19107
    United States

    Site Not Available

  • Palmetto Nephrology Pa

    Orangeburg, South Carolina 29118
    United States

    Site Not Available

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina 29303
    United States

    Site Not Available

  • Texas Health Presbyterian Dallas

    Dallas, Texas 75231
    United States

    Site Not Available

  • Michael E. De Bakey Veteran Affairs Medical Center

    Houston, Texas 77030
    United States

    Site Not Available

  • Sonterra Clinical Research

    San Antonio, Texas 78258
    United States

    Site Not Available

  • Intermountain Medical Center

    Murray, Utah 84107
    United States

    Site Not Available

  • University Of Utah Medical Center

    Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Mcguire Va Medical Center

    Richmond, Virginia 23249
    United States

    Site Not Available

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