- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00457002
Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness (ADOPT)
A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1181ACH
- Local Institution
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Cordoba, Argentina, 5000
- Local Institution
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Cordoba, Argentina, X5006IKK
- Local Institution
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Corrientes, Argentina, 3400
- Local Institution
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Buenos Aires
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Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1280AEB
- Local Institution
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Coronel Suarez, Buenos Aires, Argentina, B7540GHD
- Local Institution
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Derqui-Pilar, Buenos Aires, Argentina, B1629ODT
- Local Institution
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La Plata, Buenos Aires, Argentina, 1900
- Local Institution
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Munro, Buenos Aires, Argentina, B1605DSX
- Local Institution
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San Martin, Buenos Aires, Argentina, B1650CSQ
- Local Institution
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- Local Institution
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Rosario, Santa Fe, Argentina, S2002KDS
- Local Institution
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Tucuman
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San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
- Local Institution
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New South Wales
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Concord, New South Wales, Australia, 2139
- Local Institution
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St Leonards, New South Wales, Australia, 2065
- Local Institution
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Queensland
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Kippa Ring, Queensland, Australia, 4021
- Local Institution
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Woolloongabba, Queensland, Australia, 4102
- Local Institution
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South Australia
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Bedford Park, South Australia, Australia, 5042
- Local Institution
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Woodville, South Australia, Australia, 5011
- Local Institution
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Victoria
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Box Hill, Victoria, Australia, 3128
- Local Institution
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Parkville, Victoria, Australia, 3050
- Local Institution
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Ringwood East, Victoria, Australia, 3135
- Local Institution
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Graz, Austria, 8036
- Local Institution
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Wien, Austria, 1090
- Local Institution
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Antwerpen, Belgium, 2060
- Local Institution
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Brasschaat, Belgium, 2930
- Local Institution
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Bruxelles, Belgium, 1070
- Local Institution
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Huy, Belgium, 4500
- Local Institution
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Leuven, Belgium, 3000
- Local Institution
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Waals-Brabant
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Ottignies, Waals-Brabant, Belgium, 1340
- Local Institution
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Sao Paulo, Brazil, 05403
- Local Institution
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Sao Paulo, Brazil, 04025
- Local Institution
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Sao Paulo, Brazil, 04012
- Local Institution
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Sao Paulo, Brazil, 04020
- Local Institution
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Minas Gerais
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Belo Horizonte, Minas Gerais, Brazil, 30150
- Local Institution
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Parana
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Curitiba, Parana, Brazil, 80810
- Local Institution
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Curitiba, Parana, Brazil, 80010
- Local Institution
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020
- Local Institution
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Porto Alegre, Rio Grande Do Sul, Brazil, 91430
- Local Institution
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Sao Paulo
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Botucatu, Sao Paulo, Brazil, 18618
- Local Institution
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Campinas, Sao Paulo, Brazil, 13059
- Local Institution
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15091
- Local Institution
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Ontario
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Ajax, Ontario, Canada, L1S 7K8
- Local Institution
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Hamilton, Ontario, Canada, L8N 4A6
- Local Institution
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Hamilton, Ontario, Canada, L8N 3Z5
- Local Institution
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Windsor, Ontario, Canada, N8X 5A6
- Local Institution
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Windsor, Ontario, Canada, N9A 1C9
- Local Institution
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Quebec
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Granby, Quebec, Canada, J2G 1T7
- Local Institution
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Greenfield Park, Quebec, Canada, J4V 2H1
- Local Institution
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Montreal, Quebec, Canada, H3T 1E2
- Local Institution
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Montreal, Quebec, Canada, H1T 2M4
- Local Institution
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Montreal, Quebec, Canada, H2L 4M1
- Local Institution
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Araucania
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Temuco, Araucania, Chile, - - - - -
- Local Institution
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Metropolitana
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Santiago, Metropolitana, Chile, 7500922
- Local Institution
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Santiago, Metropolitana, Chile, 8207257
- Local Institution
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Valparaiso
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Rancagua, Valparaiso, Chile
- Local Institution
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Bogota, Colombia
- Local Institution
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Bucaramanga, Colombia
- Local Institution
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Medellin, Colombia
- Local Institution
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Brno, Czech Republic, 656 91
- Local Institution
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Jindrichuv Hradec, Czech Republic, 377 38
- Local Institution
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Kladno, Czech Republic, 272 59
- Local Institution
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Kyjov, Czech Republic, 697 01
- Local Institution
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Ostrava, Czech Republic, 728 80
- Local Institution
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Prague 2, Czech Republic, 128 08
- Local Institution
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Praha 1, Czech Republic, 110 00
- Local Institution
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Praha 5, Czech Republic, 150 06
- Local Institution
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Usti Nad Labem, Czech Republic, 401 13
- Local Institution
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Aalborg, Denmark, 9100
- Local Institution
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Aarhus N, Denmark, 8200
- Local Institution
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Arhus C, Denmark, 8000
- Local Institution
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Frederiksberg, Denmark, 2000
- Local Institution
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Glostrup, Denmark, 2600
- Local Institution
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Hellerup, Denmark, 2900
- Local Institution
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Herlev, Denmark, 2730
- Local Institution
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Herning, Denmark, 7400
- Local Institution
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Hvidovre, Denmark, 2650
- Local Institution
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Odense, Denmark, 5000
- Local Institution
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Randers No, Denmark, 8930
- Local Institution
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Silkeborg, Denmark, 8600
- Local Institution
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Bordeaux, France, 33075
- Local Institution
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Brest, France, 29200
- Local Institution
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Brest Cedex, France, 29609
- Local Institution
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Dijon Cedex, France, 21079
- Local Institution
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Grenoble Cedex 9, France, 38043
- Local Institution
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Lille Cedex, France, 59020
- Local Institution
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Nancy, France, 54035
- Local Institution
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Nimes Cedex 9, France, 30029
- Local Institution
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Paris Cedex 10, France, 75475
- Local Institution
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Paris Cedex 15, France, 75908
- Local Institution
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Saint Etienne Cedex 02, France, 42055
- Local Institution
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Vernon, France, 27207
- Local Institution
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Bonn, Germany, 53127
- Local Institution
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Coburg, Germany, 96450
- Local Institution
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Darmstadt, Germany, 64283
- Local Institution
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Dresden, Germany, 01307
- Local Institution
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Dresden, Germany, 01099
- Local Institution
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Hannover, Germany, 30625
- Local Institution
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Karlsbad, Germany, 76307
- Local Institution
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Luebeck, Germany, 23538
- Local Institution
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Mannheim, Germany, 68167
- Local Institution
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Offenbach, Germany, 63069
- Local Institution
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Witten, Germany, 58455
- Local Institution
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Shatin, N.T., Hong Kong
- Local Institution
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Budapest, Hungary, 1135
- Local Institution
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Debrecen, Hungary, 4032
- Local Institution
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Dunaujvaros, Hungary, 2400
- Local Institution
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Eger, Hungary, 3300
- Local Institution
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Ahmedabad, India, 380054
- Local Institution
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Bangalore, India, 560017
- Local Institution
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Bangalore, India, 560054
- Local Institution
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Hyderabad, India, 500033
- Local Institution
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Mumbai, India, 400008
- Local Institution
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New Delhi, India, 110025
- Local Institution
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Andhra-Pradesh
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Vishakapatnam, Andhra-Pradesh, India, 530002
- Local Institution
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Andra Pradesh
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Hyderabad, Andra Pradesh, India, 500004
- Local Institution
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Gujarat
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Ahemdabad, Gujarat, India, 380054
- Local Institution
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Karnataka
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Bangalore, Karnataka, India, 560034
- Local Institution
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Madhya Pardesh
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Indore, Madhya Pardesh, India, 452018
- Local Institution
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Maharashtra
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Pune, Maharashtra, India, 411001
- Local Institution
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Pune, Maharashtra, India, 411004
- Local Institution
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Maharastra
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Pune, Maharastra, India, 411001
- Local Institution
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Punjab
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Ludhiana, Punjab, India, 141001
- Local Institution
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641004
- Local Institution
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Madurai, Tamil Nadu, India, 625107
- Local Institution
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Tamil-Nadu
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Chennai, Tamil-Nadu, India, 600096
- Local Institution
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Uttar Pradesh
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Noida, Uttar Pradesh, India, 201301
- Local Institution
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Afula, Israel, 18101
- Local Institution
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Ashkelon, Israel, 78308
- Local Institution
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Beer Sheva, Israel, 84105
- Local Institution
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Haifa, Israel, 31096
- Local Institution
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Petach Tikva, Israel, 49100
- Local Institution
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Safed, Israel, 13110
- Local Institution
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Tel Hashomer, Israel, 52621
- Local Institution
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Tel-Aviv, Israel, 64239
- Local Institution
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Zerifin, Israel, 70300
- Local Institution
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Chieti Scalo, Italy, 66013
- Local Institution
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Cremona, Italy, 26100
- Local Institution
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Padua, Italy, 35128
- Local Institution
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Piacenza, Italy, 29100
- Local Institution
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Reggio Emilia, Italy, 42100
- Local Institution
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Treviso, Italy, 31100
- Local Institution
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Vicenza, Italy, 36100
- Local Institution
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Seoul, Korea, Republic of, 120-752
- Local Institution
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Seoul, Korea, Republic of, 135-710
- Local Institution
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Seoul, Korea, Republic of, 137-040
- Local Institution
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Seoul, Korea, Republic of, 136-705
- Local Institution
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Suwon, Korea, Republic of, 443721
- Local Institution
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Gyeonggi-Do
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Guri-Si, Gyeonggi-Do, Korea, Republic of, 471-701
- Local Institution
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Seongnam-Si, Gyeonggi-Do, Korea, Republic of, 463-707
- Local Institution
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Johor Bahru, Malaysia, 80100
- Local Institution
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Kelantan
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Kubang Kerian, Kelantan, Malaysia, 16150
- Local Institution
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Selangor
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Batu Caves, Selangor, Malaysia, 68100
- Local Institution
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Queretaro, Mexico, 76178
- Local Institution
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San Luis Potosi, Mexico, 78220
- Local Institution
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Distrito Federal
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Mexico, Distrito Federal, Mexico, 06726
- Local Institution
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Mexico, Distrito Federal, Mexico, 07760
- Local Institution
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Nuevo Leon
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Monterrey, Nuevo Leon, Mexico, 64460
- Local Institution
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Veracruz
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Xalapa, Veracruz, Mexico, 91020
- Local Institution
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Yucatan
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Merida, Yucatan, Mexico, 97129
- Local Institution
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Den Helder, Netherlands, 1782 GZ
- Local Institution
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Kongsvinger, Norway, 2226
- Local Institution
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Arequipa, Peru, AREQUIPA54
- Local Institution
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Callao, Peru, CALLAO 2
- Local Institution
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Lima, Peru, LIMA 11
- Local Institution
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Lima, Peru, LIMA 31
- Local Institution
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Lima, Peru, LIMA 01
- Local Institution
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Lima, Peru, LIMA 1
- Local Institution
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Lima
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La Victoria, Lima, Peru, LIMA 13
- Local Institution
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Las Pinas, Philippines, 1742
- Local Institution
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Quezon City, Philippines, 1102
- Local Institution
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Quezon City, Philippines, 1100
- Local Institution
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Quezon City, Philippines, 1110
- Local Institution
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Misamis Oriental
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Cagayan De Oro City, Misamis Oriental, Philippines, 9000
- Local Institution
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Bydgoszcz, Poland, 85-168
- Local Institution
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Krakow, Poland, 31-202
- Local Institution
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Lodz, Poland, 91-347
- Local Institution
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Nowa Sol, Poland, 67-100
- Local Institution
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Poznan, Poland, 61-833
- Local Institution
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Skierniewice, Poland, 96-100
- Local Institution
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Warszawa, Poland, 01-138
- Local Institution
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Warszawa, Poland, 03-737
- Local Institution
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Wejherowo, Poland, 84-200
- Local Institution
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Zielona Gora, Poland, 65-046
- Local Institution
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Moscow, Russian Federation, 121309
- Local Institution
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Moscow, Russian Federation, 119991
- Local Institution
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Moscow, Russian Federation, 111539
- Local Institution
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Moscow, Russian Federation, 115280
- Local Institution
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Moscow, Russian Federation, 117292
- Local Institution
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Moscow, Russian Federation, 117593
- Local Institution
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Moscow, Russian Federation, 127018
- Local Institution
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Moscow, Russian Federation, 129336
- Local Institution
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Odintsovo, Russian Federation, 143000
- Local Institution
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Podolsk, Russian Federation, 142100
- Local Institution
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Ryazan, Russian Federation, 390005
- Local Institution
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Saint Petersburg, Russian Federation, 199106
- Local Institution
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Saint-Petersburg, Russian Federation, 198205
- Local Institution
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Saratov, Russian Federation, 410054
- Local Institution
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Saratov, Russian Federation, 410002
- Local Institution
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St Petersburg, Russian Federation, 195067
- Local Institution
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St. Petersburg, Russian Federation, 193312
- Local Institution
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St.Petersburg, Russian Federation, 192242
- Local Institution
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Singapore, Singapore, 308433
- Local Institution
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Singapore, Singapore, 529889
- Local Institution
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Groenkloof, South Africa, 0181
- Local Institution
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Free State
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Bloemfontein, Free State, South Africa, 9301
- Local Institution
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Gauteng
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Johannesburg, Gauteng, South Africa, 2193
- Local Institution
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Pretoria, Gauteng, South Africa, 0044
- Local Institution
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Kwa Zulu Natal
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Amanzimtoti, Kwa Zulu Natal, South Africa, 4120
- Local Institution
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Western Cape
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Bellville, Western Cape, South Africa, 7530
- Local Institution
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Alcorcon(Madrid), Spain, 28922
- Local Institution
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Barcelona, Spain, 08036
- Local Institution
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Barcelona, Spain, 08003
- Local Institution
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Madrid, Spain, 28041
- Local Institution
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Madrid, Spain, 28034
- Local Institution
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Madrid, Spain, 28006
- Local Institution
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Madrid, Spain, 28007
- Local Institution
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Madrid, Spain, 28046
- Local Institution
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Sevilla, Spain, 41013
- Local Institution
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Tarragona, Spain, 43007
- Local Institution
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Alicante
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Torrevieja, Alicante, Spain, 03186
- Local Institution
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Goteborg, Sweden, 413 45
- Local Institution
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Lund, Sweden, 221 85
- Local Institution
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Taichung, Taiwan, 402
- Local Institution
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Tainan
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Yung-Kang City, Tainan, Taiwan, 710
- Local Institution
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Istanbul, Turkey, 34390
- Local Institution
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Capa
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Istanbul, Capa, Turkey, 34390
- Local Institution
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Dikimevi
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Ankara, Dikimevi, Turkey, 06100
- Local Institution
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Donetsk, Ukraine, 83003
- Local Institution
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Kharkiv, Ukraine, 61018
- Local Institution
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Kharkiv, Ukraine, 61176
- Local Institution
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Kharkov, Ukraine, 61039
- Local Institution
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Kyiv, Ukraine, 03680
- Local Institution
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Kyiv, Ukraine, 02091
- Local Institution
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Kyiv, Ukraine, 01133
- Local Institution
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Kyiv, Ukraine, 03115
- Local Institution
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Kyiv, Ukraine, 03151
- Local Institution
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Kyiv, Ukraine, 04050
- Local Institution
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Kyiv, Ukraine, 04201
- Local Institution
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Lutsk, Ukraine, 43024
- Local Institution
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Lviv, Ukraine, 79010
- Local Institution
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Uzhgorod, Ukraine, 88000
- Local Institution
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Vinnitsa, Ukraine, 21029
- Local Institution
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Greater London
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London, Greater London, United Kingdom, SE5 9RS
- Local Institution
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London, Greater London, United Kingdom, SW3 6LR
- Local Institution
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Middlesex
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Uxbridge, Middlesex, United Kingdom, UB8 3NN
- Local Institution
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Tyne And Wear
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Newcastle, Tyne And Wear, United Kingdom, NE7 7DN
- Local Institution
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West Midlands
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Dudley, West Midlands, United Kingdom, DY1 2HQ
- Local Institution
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Yorkshire
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Hull, Yorkshire, United Kingdom, HU3 2JZ
- Local Institution
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama At Birmingham Hospital
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Huntsville, Alabama, United States, 35801
- Heart Center Research, LLC
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Arizona
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Phoenix, Arizona, United States, 85013
- Arizona Pulmonary Specialists, Ltd.
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Scottsdale, Arizona, United States, 85258
- Az Pulmonary Specialists Ltd
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Arkansas
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Fort Smith, Arkansas, United States, 72901
- Fort Smith Lung Center
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California
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La Jolla, California, United States, 92037
- Scripps Clinic/Scripps Health And Green Hospital
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Long Beach, California, United States, 90822
- VA Long Beach Healthcare System
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Los Angeles, California, United States, 90033
- Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
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Oakland, California, United States, 94609
- Dr. Felt Medical Office
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Stanford, California, United States, 94305
- Stanford University
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Connecticut
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New Haven, Connecticut, United States, 06510
- Yale University School of Medicine
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Norwalk, Connecticut, United States, 06856
- Norwalk Hospital
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District of Columbia
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Washington, District of Columbia, United States, 20037
- George Washington University
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Florida
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Celebration, Florida, United States, 34747
- Florida Hospital Celebration Health
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Clearwater, Florida, United States, 33756
- Research Alliance, Inc.
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Jacksonville, Florida, United States, 32216
- Jacksonville Center for Clinical Research
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Pensacola, Florida, United States, 32504
- Pensacola Lung Group
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Vero Beach, Florida, United States, 32960
- Indian River Med. Ctr.
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Georgia
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Atlanta, Georgia, United States, 30342
- Pulmonary & Critical Care of Atlanta
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Atlanta, Georgia, United States, 30030
- Atlanta Institute For Medical Research, Inc
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Idaho
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Idaho Falls, Idaho, United States, 83404
- Idaho Falls Infectious Diseases, PLLC
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Illinois
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Oak Park, Illinois, United States, 60302
- West Suburban Hospital
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Indiana
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Carmel, Indiana, United States, 46032
- Infectious Disease Of Indiana Psc
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Kansas
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Topeka, Kansas, United States, 66604
- Cotton-O-Neil Clinical Research Center
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Louisiana
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Shreveport, Louisiana, United States, 71103
- Louisiana State University Health Sciences Center-Shreveport
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Maryland
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Baltimore, Maryland, United States, 21205
- Johns Hopkins University School of Medicine
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Baltimore, Maryland, United States, 21237
- Franklin Square Hospital
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Michigan
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Detriot, Michigan, United States, 48202
- Henry Ford Hospital, Transplant Institute
-
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Missouri
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Columbia, Missouri, United States, 65212
- University of Missouri-Columbia
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Montana
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Butte, Montana, United States, 59701
- Mercury Street Medical Group, PLLC
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Nebraska
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Omaha, Nebraska, United States, 68131
- Creighton University Medical Center
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New Jersey
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Mornstown, New Jersey, United States, 07962
- Morristown Memorial Hospital
-
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New York
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Staten Island, New York, United States, 10305
- Staten Island University Hospital
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North Carolina
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Asheville, North Carolina, United States, 28801
- Mission Hospital, Inc
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73135
- South Oklahoma Heart Research
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Pennsylvania
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Allentown, Pennsylvania, United States, 18103
- Lehigh Valley Hospital
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Hershey, Pennsylvania, United States, 17033
- The Milton S Hershey Medical Center Of Penn. State Univ.
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Philadelphia, Pennsylvania, United States, 19107
- Thomas Jefferson University
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South Carolina
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Orangeburg, South Carolina, United States, 29118
- Palmetto Nephrology Pa
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Spartanburg, South Carolina, United States, 29303
- S. Carolina Pharmaceutical Research
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Texas
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Dallas, Texas, United States, 75231
- Texas Health Presbyterian Dallas
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Houston, Texas, United States, 77030
- Michael E. De Bakey Veteran Affairs Medical Center
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San Antonio, Texas, United States, 78258
- Sonterra Clinical Research
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San Antonio, Texas, United States, 78205
- Sonterra Clinical Research
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Utah
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Murray, Utah, United States, 84107
- Intermountain Medical Center
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Salt Lake City, Utah, United States, 84132
- University of Utah Medical Center
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Virginia
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Richmond, Virginia, United States, 23249
- McGuire VA Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 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 other than aspirin at a dose ≤ 165 mg/day.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Arm 1
While hospitalized, Apixaban plus Placebo Apixaban (Tablets, Oral, 2.5 mg), Placebo (Syringes, SC) After hospital discharge, Apixaban Apixaban (Tablets, Oral, 2.5 mg) |
Apixaban: Twice daily, 30 days Placebo: Once daily, 6-14 days
Other Names:
|
ACTIVE_COMPARATOR: Arm 2
While hospitalized, Enoxaparin plus Placebo Enoxaparin (Syringes, SC, 40 mg), Placebo (Tablets, Oral) After hospital discharge: Placebo Placebo (Tablets, Oral) |
Enoxaparin: Once daily, 6-14 days Placebo: Twice daily, 30 days |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
Time Frame: Intended Treatment Period
|
VTE: nonfatal pulmonary embolism (PE), symptomatic deep vein thrombosis (DVT), or asymptomatic proximal DVT detected by ultrasound.
VTE-related death: fatal PE or sudden death for which VTE could not be excluded as a cause.
Intended Treatment Period=period that started on day of randomization: period ended (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; period ended (for not treated) 32 days after randomization.
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior.
CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time.
All efficacy events were adjudicated by the Independent Central Adjudication Committee (ICAC).
Event rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Major Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Major bleeding was adjudicated by an ICAC using criteria from the International Society on Thrombosis and Hemostasis (ISTH) and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or bleeding in a critical site or bleeding which is fatal.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Bleeding was adjudicated by an ICAC using criteria from the ISTH.
CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis, if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss.
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for bleeding endpoints.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Bleeding was adjudicated by an ICAC using criteria from the ISTH.
Major bleeding: acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or bleeding in a critical site or bleeding which is fatal.
CRNM bleeding: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding; spontaneous hematuria; macroscopic gastrointestinal hemorrhage; rectal blood loss.
Treatment Period=onset from first dose of study drug through 2 days after last dose of study drugs.
Incidence: Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Day 1, first dose of study drug, to last dose of study drug plus 2 days
|
Incidence of All Bleeding During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of drug to last dose of drug plus 2 days
|
Bleeding was adjudicated by an ICAC using criteria from the ISTH.
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs, for bleeding endpoints.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Day 1, first dose of drug to last dose of drug plus 2 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
Time Frame: Day 1 to last dose of parenteral study drug plus 1 day
|
Parenteral study drug=active or placebo enoxaparin.
Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug.
Key Secondary Efficacy population: all who received at least 1 dose of parenteral study drug and: (those without suspected VTE events during Parenteral Treatment) had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or (those with suspected VTE events during Parenteral Treatment) had those suspected VTE events adjudicated as non-events, and had an adjudicated evaluable ultrasound performed at the end of Parenteral Treatment; or had an adjudicated total VTE during Parenteral Treatment; or had an adjudicated VTE-related death during Parenteral Treatment.
Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
|
Day 1 to last dose of parenteral study drug plus 1 day
|
Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
Time Frame: Day 1 to last dose of parenteral study drug plus 1 day
|
Parenteral study drug=active or placebo enoxaparin.
Parenteral treatment: started on the first dose of parenteral study drug and ended the day after the last dose of parenteral study drug.
Secondary Efficacy Evaluable includes those who had an adjudicated, evaluable ultrasound at end of parenteral treatment and for those with a suspected symptomatic event, the result of the adjudication for the symptomatic event was not inadequate; or those with an adjudicated event that was part of the composite endpoint.. Event rate (%): n/N*100 (n=number with observation; N=total secondary efficacy evaluable participants).
|
Day 1 to last dose of parenteral study drug plus 1 day
|
Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE: nonfatal (N-F) PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound.
VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause.
All-Cause Death (A-C Death).
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound.
VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
VTE: nonfatal PE, symptomatic DVT, or asymptomatic proximal DVT detected by ultrasound.
VTE-related death: fatal PE or sudden death for which VTE cannot be excluded as a cause.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated PE With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
PE: non-fatal or fatal.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior.
CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events were adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior.
CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
Time Frame: Intended Treatment Period
|
A bilateral compression ultrasound (CUS) was performed between Days 5 and 14 for detection of asymptomatic proximal DVT unless a symptomatic VTE was confirmed prior.
CUS was also performed on Day 30 ± 2 except for those participants who had a confirmed symptomatic VTE or proximal asymptomatic DVT prior to that time.
Events adjudicated by ICAC.
Intended Treatment Period=period that starts on day of randomization: period ends (for treated) at latter of a) 2 days after last dose of study drug and b) 32 days after first dose of study drug; (for not treated) period ends 32 days after randomization.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
|
Intended Treatment Period
|
Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
Time Frame: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
|
Treatment Period=includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs for AEs, and 30 days after last dose of study drugs for SAEs and deaths.
|
Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
|
Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Diastolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken with the participant either sitting, standing, or supine.
|
Day 1 to last dose of study drug plus 2 days
|
Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Systolic blood pressure was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Blood pressure was measured in millimeters of mercury (mmHg) and could have been taken either sitting, standing, or supine.
|
Day 1 to last dose of study drug plus 2 days
|
Mean Change From Baseline in Heart Rate in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Heart Rate was obtained during Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
Heart rate was measured in beats per minute (bpm) and could have been taken with participants either sitting, standing, or supine.
|
Day 1 to last dose of study drug plus 2 days
|
Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Lower limit of normal (LLN).
Upper limit of normal (ULN).
Pre-therapy (PreRx).
Absolute (Abs) neutrophil count, bands + neutrophils (ANC).
Cells per microliter (c/µL).
Grams per deciliter (g/dL).
Cells per Liter (c/L).
Millimeter (MM).
Absolute (Abs).
Hemoglobin: >2 g/dL decrease compared to PreRx value or value <=8 g/dL; Hematocrit: <0.75*PreRx; Erythrocytes: <0.75*PreRx c/µL; Leukocytes: <0.75*LLN or > 1.25*ULN, if PreRx <LLN then use <0.8*PreRx or >ULN, if PreRx >ULN then use >1.2*PreRx or < LLN; Platelet count: < 100*10^9 c/L; ANC: < 1.00*10^3 c/µL; Abs eosinophils: > 0.75*10^3 c/µL; Abs Basophils: > 400/MM^3; Abs Monocytes > 2000/MM^3; Abs Lymphocytes: < 0.750*10*3 c/ µL or > 7.5*10^3 c/ µL.
Samples were obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
|
Day 1 to last dose of study drug plus 2 days
|
Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Bicarbonate milliequivalents/Liter (mEq/L) Low/High: < 0.75*LLN or > 1.25*ULN, or if PreRx < LLN then use < 0.75* PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Calcium mg/dL Low/High: < 0.8*LLN or > 1.2*ULN, or if PreRx < LLN then use < 0.75*PreRx or > ULN if PreRx > ULN then use > 1.25*PreRx or < LLN; Serum Chloride mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Potassium mEq/L: < 0.9*LLN or > 1.1*ULN, or if PreRx < LLN then use < 0.9*PreRx or > ULN if PreRx > ULN then use > 1.1*PreRx or < LLN; Serum Sodium mEq/L: < 0.95*LLN or > 1.05*ULN, or if PreRx < LLN then use < 0.95*PreRx or > ULN if PreRx > ULN then use > 1.05*PreRx or < LLN.
Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
|
Day 1 to last dose of study drug plus 2 days
|
Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Blood urea nitrogen (BUN), milligrams/deciliter (mg/dL), units per liter (U/L).
BUN mg/dL > 1.5*ULN; Creatinine mg/dL: > 1.5*ULN; Alanine aminotransferase (ALT) U/L: > 3*ULN; Aspartate aminotransferase (AST) U/L: > 3*ULN; Alkaline phosphatase U/L: > 2*ULN; Bilirubin Direct mg/dL: > 1.5*ULN; Bilirubin Total mg/dL: > 2*ULN.
Samples for laboratories obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) plus 2 days.
|
Day 1 to last dose of study drug plus 2 days
|
Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Creatine kinase High: >5*ULN Units/Liter (U/L); Total Protein High/Low: < 0.9 *LLN or > 1.1*ULN, or if PreRx < LLN then use 0.9* PreRx or > ULN if PreRx > ULN then use 1.1 *PreRx or <LLN; Uric acid High: > 1.5* ULN, or if PreRx > ULN then use > 2 *PreRx.
Glucose Fasting: <0.9*LLN or > 1.5*ULN or if PreRx < LLN then use < 0.8*PreRx or > ULN, if PreRx > ULN then use >2.0*PreRx.
Samples obtained at Screening/Enrollment Visit (Day 1, prior to drug being administered), on the day of hospital discharge, Day 30 (last day of treatment) ± 2days.
|
Day 1 to last dose of study drug plus 2 days
|
Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Events of Special Interest include: adjudicated thrombocytopenia, adjudicated myocardial infarction (MI), adjudicated stroke, and adjudicated MI or stroke.
Incidence determined by Event Rate (%): n/N*100 (n=number with observation; N=total efficacy evaluable participants).
Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drugs.
|
Day 1 to last dose of study drug plus 2 days
|
Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
Time Frame: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
|
Special interest include: liver function test increases, AEs related to liver function, and neurologic AEs.
Treatment Period includes measurements or events with onset from first dose of study drug through 2 days after the last dose of study drug when summarizing AEs and through 30 days after the last dose when summarizing SAEs.
|
Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
|
Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
Time Frame: Day 1 to last dose of study drug plus 2 days
|
Liver function tests: Alanine aminotransferase (ALT) U/L; Aspartate aminotransferase (AST) U/L; Alkaline phosphatase U/L; Total Bilirubin (TBili) mg/dL.
Elevations consist of >3*Upper Limit of Normal (ULN) for ALT and AST and elevation of >2*ULN for Bilirubin.
|
Day 1 to last dose of study drug plus 2 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.
- Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.
- Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.
- Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Respiratory Tract Diseases
- Lung Diseases
- Embolism and Thrombosis
- Embolism
- Thrombosis
- Venous Thrombosis
- Pulmonary Embolism
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Protease Inhibitors
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Apixaban
- Enoxaparin
Other Study ID Numbers
- CV185-036
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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