Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
NCT ID: NCT03045406
Last Updated: 2025-06-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1170 participants
INTERVENTIONAL
2017-04-13
2019-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Apixaban
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Apixaban
Tablets
Dalteparin
subcutaneously administered, at a dose of 200 IU/kg SC o.i.d for 1 month. Thereafter, dalteparin will be administered at a dose of 150 IU/kg o.i.d. for 5 months
Dalteparin
Injections
Interventions
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Apixaban
Tablets
Dalteparin
Injections
Eligibility Criteria
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Inclusion Criteria
* Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or intracerebral metastasis and acute leukemia);
* Signed and dated informed consent of the patient, available before the start of any specific trial procedure.
Exclusion Criteria
* ECOG Performance Status III or IV;
* life expectancy of less than 6 months;
Related to anticoagulant treatment:
* administration of therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for more than 72 hours before randomization;
* 3 or more doses of a vitamin K antagonist before randomization;
* thrombectomy, vena cava filter insertion, or thrombolysis used to manage the index episode;
* indication for anticoagulant treatment for a disease other than the index VTE episode;
Related to bleeding risk:
* thienopyridine therapy (clopidogrel, prasugrel, or ticagrelor) or aspirin over 165 mg daily or dual antiplatelet therapy;
* active bleeding or a high risk of bleeding contraindicating anticoagulant treatment;
* recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery
* hemoglobin level lower than 8 g/dL (5.0 mmol/L) or platelet count \<75x10\^9/L or history of heparin induced thrombocytopenia;
* creatinine clearance \< 30 ml /min based on the Cockcroft Gault equation;
* acute hepatitis, chronic active hepatitis, liver cirrhosis; or an alanine aminotransferase level 3 times or more and/or bilirubin level 2 times or more higher the upper limit of the normal range;
* uncontrolled hypertension (systolic BP\> 180 mmHg or diastolic BP \> 100 mmHg despite antihypertensive treatment);
* concomitant use of strong inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein;
Standard criteria:
* bacterial endocarditis;
* hypersensitivity to the active substance or to any of the excipients of study drug;
* patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system;
* childbearing potential without proper contraceptive measures, pregnancy, or breast feeding;
* any condition that as judged by the Investigator would place the subject at increased risk of harm if he/she participated in the study.
18 Years
ALL
No
Sponsors
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University Of Perugia
OTHER
Fadoi Foundation, Italy
OTHER
Responsible Party
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Principal Investigators
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Gualberto Gussoni, MD
Role: STUDY_DIRECTOR
FADOI Foundation
Locations
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University of Southern California
Los Angeles, California, United States
Georgetown University
Washington D.C., District of Columbia, United States
University of Florida
Gainesville, Florida, United States
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
Emory University
Atlanta, Georgia, United States
Brigham and Women's Hospital/DFCI
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
New York-Presbyterian Hospital
New York, New York, United States
Staten Island University Hospital/Northwell Health
Staten Island, New York, United States
Albert Einstein College of Medicine
The Bronx, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States
Cliniques universitaires Saint-Luc
Brussels, , Belgium
KU Leuven
Leuven, , Belgium
Hôpital Privé Arras Les Bonnettes
Arras, , France
CHU Bordeaux Hôpital Saint André
Bordeaux, , France
Hopital Cavale Blanche
Brest, , France
Hôpital des armées HIA Clermont Tonnerre
Brest, , France
Centre Hospitalier Universitaire de Clermont-Ferrand
Clermont-Ferrand, , France
Hôpital Louis Mourier
Colombes, , France
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, , France
Centre Hospitalier Universitaire Grenoble Alpes
Grenoble, , France
CH de Vendée Centre Hospitalier Départemental
La Roche-sur-Yon, , France
Centre Hospitalier Emile Roux Le Puy-en-Velay
Le Puy-en-Velay, , France
Université de Limoges
Limoges, , France
Centre Hospitalier Universitaire Lyon-Sud
Lyon, , France
Hopital Pasteur - Chu de Nice
Nice, , France
Hôpital Europeen Georges Pompidou
Paris, , France
Université Jean Monnet
Saint-Etienne, , France
Hôpital Sainte Musse
Toulon, , France
Klinikum Darmstadt
Darmstadt, , Germany
Städtisches Klinikum Dresden-Friedrichstadt
Dresden, , Germany
Universitäts GefäßCentrum (UGC)
Dresden, , Germany
Universitätskrankenhaus Hamburg-Eppendorf
Hamburg, , Germany
Forschungszentrum Ruhr
Witten, , Germany
Haemek Medical Center
Afula, , Israel
Soroka University Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Galilee Medical Center
Nahariya, , Israel
Rabin Medical Center
Petah Tikva, , Israel
AOU Ospedali Riuniti di Ancona
Ancona, , Italy
AOSG Moscati
Avellino, , Italy
Ospedale Sacro Cuore di Gesù Fatebenefratelli
Benevento, , Italy
ASST Papa Giovanni XXIII
Bergamo, , Italy
Ospedale Maggiore
Bologna, , Italy
Ospedale San Giacomo Apostolo
Castelfranco Veneto, , Italy
Ospedale di Cosenza
Cosenza, , Italy
Ospedale SS Annunziata
Cuneo, , Italy
AOU Careggi
Florence, , Italy
AOU San Martino
Genova, , Italy
AOU di Modena
Modena, , Italy
AO di Rilievo Nazione Antonio Cardarelli
Napoli, , Italy
Istituto Nazionale Tumori - IRCCS Fondazione Pascale
Napoli, , Italy
Ospedale Buon Consiglio Fatebenefratelli
Napoli, , Italy
Ospedale San Martino
Oristano, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
AO Ospedali Riuniti Villa Sofia
Palermo, , Italy
Department of Internal Medicine - University of Perugia
Perugia, , Italy
Ospedale SS Cosma e Damiano
Pescia, , Italy
Ospedale di Piacenza
Piacenza, , Italy
AOU Pisana
Pisa, , Italy
Ospedale di Pitigliano
Pitigliano, , Italy
Ospedale di Ravenna
Ravenna, , Italy
Arcispedale S. Maria Nuova
Reggio Emilia, , Italy
Ospedale San Giovanni Calibita Fatebenefratelli
Roma, , Italy
Policlinico Agostino Gemelli
Roma, , Italy
Ospedale S. Paolo
Savona, , Italy
AO Santa Maria
Terni, , Italy
Ospedale Cà Foncello
Treviso, , Italy
Ospedale di Udine
Udine, , Italy
AO Ospedale di Circolo e Fondazione Macchi
Varese, , Italy
Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.
Verona, , Italy
Ospedale San Bortolo
Vicenza, , Italy
Ziekenhuisgroep Twente ZGT
Almelo, , Netherlands
Academic Medical Centre
Amsterdam, , Netherlands
Rijnstate Arnhem
Arnhem, , Netherlands
Rode Kruis Ziekenhuis Beverwijk
Beverwijk, , Netherlands
Amphia Hospital Breda
Breda, , Netherlands
Slingeland Doetinchem
Doetinchem, , Netherlands
Albert Schweitzer ziekenhuis
Dordrecht, , Netherlands
Medisch Spectrum Twente
Enschede, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus MC
Rotterdam, , Netherlands
Haaglanden Hospital Den Haag
The Hague, , Netherlands
HagaZiekenhuis
The Hague, , Netherlands
Szpital Brzozów
Brzozów, , Poland
Świetokrzyskie Centrum Onkologii
Kielce, , Poland
Opolskie Centrum Onkologii
Opole, , Poland
Medical Centre for Postgraduate Education - ECZ-Otwock
Otwock, , Poland
CMKP
Otwock, , Poland
Wielkoposkie Centrum Onkologii
Poznan, , Poland
IPO Lisboa
Lisbon, , Portugal
IPO Porto
Porto, , Portugal
Tràs-Os Montes e Alto Douro
Vila Real, , Portugal
Hospital Torrecardenas
Almería, , Spain
Hospital Sant Pau
Barcelona, , Spain
Hospital Val d'Hebron
Barcelona, , Spain
Sabadell Hospital
Barcelona, , Spain
Fundación Jiménez Díaz
Madrid, , Spain
Hospital 12 de Octubre
Madrid, , Spain
Hospital Clara Campal
Madrid, , Spain
Hospital Clínico San Carlos
Madrid, , Spain
Hospital Fuenlabrada
Madrid, , Spain
Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Hospital Infanta Leonor
Madrid, , Spain
Hospital La Paz
Madrid, , Spain
Hospital Puerta de Hierro
Madrid, , Spain
Hospital Ramón y Cajal
Madrid, , Spain
Hospital de Málaga
Málaga, , Spain
Hospital Morales Meseguer
Murcia, , Spain
Hospital Central de Asturias
Oviedo, , Spain
Clínica Universitaria de Navarra
Pamplona, , Spain
Hospital Marqués Valdecilla
Santander, , Spain
Hospital Virgen del Rocio
Seville, , Spain
Hospital Clínico Lozano Blesa
Zaragoza, , Spain
University Hospitals Bristol
Bristol, , United Kingdom
University Hospital of Wales
Cardiff, , United Kingdom
King's College Hospital
London, , United Kingdom
Royal Gwent Hospital
Newport, , United Kingdom
Oxford University Hospital
Oxford, , United Kingdom
Countries
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References
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Becattini C, Bauersachs R, Maraziti G, Bertoletti L, Cohen A, Connors JM, Manfellotto D, Sanchez A, Brenner B, Agnelli G. Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial. Haematologica. 2022 Jul 1;107(7):1567-1576. doi: 10.3324/haematol.2021.279072.
Giustozzi M, Connors JM, Ruperez Blanco AB, Szmit S, Falvo N, Cohen AT, Huisman M, Bauersachs R, Dentali F, Becattini C, Agnelli G. Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study. J Thromb Haemost. 2021 Nov;19(11):2751-2759. doi: 10.1111/jth.15461. Epub 2021 Jul 29.
Agnelli G, Becattini C, Meyer G, Munoz A, Huisman MV, Connors JM, Cohen A, Bauersachs R, Brenner B, Torbicki A, Sueiro MR, Lambert C, Gussoni G, Campanini M, Fontanella A, Vescovo G, Verso M; Caravaggio Investigators. Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer. N Engl J Med. 2020 Apr 23;382(17):1599-1607. doi: 10.1056/NEJMoa1915103. Epub 2020 Mar 29.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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FADOI.03.2016
Identifier Type: -
Identifier Source: org_study_id
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