Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer (CARAVAGGIO)

June 20, 2025 updated by: Fadoi Foundation, Italy

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1170

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium
        • Cliniques Universitaires Saint-Luc
      • Leuven, Belgium
        • KU Leuven
  • France
      • Arras, France
        • Hopital Privé Arras les Bonnettes
      • Bordeaux, France
        • CHU Bordeaux Hopital Saint André
      • Brest, France
        • Hôpital Cavale Blanche
      • Brest, France
        • Hôpital des armées HIA Clermont Tonnerre
      • Clermont-Ferrand, France
        • Centre Hospitalier Universitaire de Clermont-Ferrand
      • Colombes, France
        • Hopital Louis Mourier
      • Dijon, France
        • Centre Hospitalier Universitaire Dijon Bourgogne
      • Grenoble, France
        • Centre Hospitalier Universitaire Grenoble Alpes
      • La Roche-sur-Yon, France
        • CH de Vendée Centre Hospitalier Départemental
      • Le Puy-en-Velay, France
        • Centre Hospitalier Emile Roux Le Puy-en-Velay
      • Limoges, France
        • Université de Limoges
      • Lyon, France
        • Centre Hospitalier Universitaire Lyon-Sud
      • Nice, France
        • Hôpital Pasteur - CHU de Nice
      • Paris, France
        • Hôpital Européen Georges Pompidou
      • Saint-Étienne, France
        • Université Jean Monnet
      • Toulon, France
        • Hopital Sainte Musse
  • Germany
      • Darmstadt, Germany
        • Klinikum Darmstadt
      • Dresden, Germany
        • Städtisches Klinikum Dresden-Friedrichstadt
      • Dresden, Germany
        • Universitäts GefäßCentrum (UGC)
      • Hamburg, Germany
        • Universitätskrankenhaus Hamburg-Eppendorf
      • Witten, Germany
        • Forschungszentrum Ruhr
  • Israel
      • Afula, Israel
        • Haemek Medical Center
      • Be'er Sheva, Israel
        • Soroka University Medical Center
      • Haifa, Israel
        • Rambam Health Care Campus
      • Kfar Saba, Israel
        • Meir Medical Center
      • Nahariya, Israel
        • Galilee Medical Center
      • Petah Tikva, Israel
        • Rabin Medical Center
  • Italy
      • Ancona, Italy
        • AOU Ospedali Riuniti di Ancona
      • Avellino, Italy
        • AOSG Moscati
      • Benevento, Italy
        • Ospedale Sacro Cuore di Gesù Fatebenefratelli
      • Bergamo, Italy
        • ASST Papa Giovanni XXIII
      • Bologna, Italy
        • Ospedale Maggiore
      • Castelfranco Veneto, Italy
        • Ospedale San Giacomo Apostolo
      • Cosenza, Italy
        • Ospedale di Cosenza
      • Cuneo, Italy
        • Ospedale SS Annunziata
      • Firenze, Italy
        • AOU Careggi
      • Genova, Italy
        • AOU San Martino
      • Modena, Italy
        • AOU di Modena
      • Napoli, Italy
        • AO di Rilievo Nazione Antonio Cardarelli
      • Napoli, Italy
        • Istituto Nazionale Tumori - IRCCS Fondazione Pascale
      • Napoli, Italy
        • Ospedale Buon Consiglio Fatebenefratelli
      • Oristano, Italy
        • Ospedale San Martino
      • Padova, Italy
        • Azienda Ospedaliera Di Padova
      • Palermo, Italy
        • AO Ospedali Riuniti Villa Sofia
      • Perugia, Italy, 06129
        • Department of Internal Medicine - University of Perugia
      • Pescia, Italy
        • Ospedale SS Cosma e Damiano
      • Piacenza, Italy
        • Ospedale di Piacenza
      • Pisa, Italy
        • AOU Pisana
      • Pitigliano, Italy
        • Ospedale di Pitigliano
      • Ravenna, Italy
        • Ospedale di Ravenna
      • Reggio Emilia, Italy
        • Arcispedale S. Maria nuova
      • Roma, Italy
        • Ospedale San Giovanni Calibita Fatebenefratelli
      • Roma, Italy
        • Policlinico Agostino Gemelli
      • Savona, Italy
        • Ospedale S. Paolo
      • Terni, Italy
        • AO Santa Maria
      • Treviso, Italy
        • Ospedale Ca Foncello
      • Udine, Italy
        • Ospedale di Udine
      • Varese, Italy
        • AO Ospedale di Circolo e Fondazione Macchi
      • Verona, Italy
        • Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.
      • Vicenza, Italy
        • Ospedale san Bortolo
  • Netherlands
      • Almelo, Netherlands
        • Ziekenhuisgroep Twente ZGT
      • Amsterdam, Netherlands
        • Academic Medical Centre
      • Arnhem, Netherlands
        • Rijnstate Arnhem
      • Beverwijk, Netherlands
        • Rode Kruis Ziekenhuis Beverwijk
      • Breda, Netherlands
        • Amphia Hospital Breda
      • Den Haag, Netherlands
        • Haaglanden Hospital Den Haag
      • Doetinchem, Netherlands
        • Slingeland Doetinchem
      • Dordrecht, Netherlands
        • Albert Schweitzer Ziekenhuis
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Leiden, Netherlands
        • Leiden University Medical Center
      • Rotterdam, Netherlands
        • Erasmus MC
      • the Hague, Netherlands
        • Hagaziekenhuis
  • Poland
      • Brzozów, Poland
        • Szpital Brzozów
      • Kielce, Poland
        • Swietokrzyskie Centrum Onkologii
      • Opole, Poland
        • Opolskie Centrum Onkologii
      • Otwock, Poland, 05-400
        • Medical Centre for Postgraduate Education - ECZ-Otwock
      • Otwock, Poland
        • CMKP
      • Poznań, Poland
        • Wielkoposkie Centrum Onkologii
  • Portugal
      • Lisboa, Portugal
        • Ipo Lisboa
      • Porto, Portugal
        • IPO Porto
      • Vila Real, Portugal
        • Tràs-Os Montes e Alto Douro
  • Spain
      • Almería, Spain
        • Hospital Torrecardenas
      • Barcelona, Spain
        • Hospital Sant Pau
      • Barcelona, Spain
        • Hospital Val d'Hebron
      • Barcelona, Spain
        • Sabadell Hospital
      • Madrid, Spain
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Fundación Jiménez Díaz
      • Madrid, Spain
        • Hospital La Paz
      • Madrid, Spain
        • Hospital Clínico San Carlos
      • Madrid, Spain
        • Hospital Infanta Leonor
      • Madrid, Spain
        • Hospital Clara Campal
      • Madrid, Spain
        • Hospital Fuenlabrada
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Murcia, Spain
        • Hospital Morales Meseguer
      • Málaga, Spain
        • Hospital de Málaga
      • Oviedo, Spain
        • Hospital Central de Asturias
      • Pamplona, Spain
        • Clinica Universitaria de Navarra
      • Santander, Spain
        • Hospital Marques Valdecilla
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Zaragoza, Spain
        • Hospital Clinico Lozano Blesa
  • United Kingdom
      • Bristol, United Kingdom
        • University Hospitals Bristol
      • Cardiff, United Kingdom
        • University Hospital of Wales
      • London, United Kingdom
        • King's College Hospital
      • Newport, United Kingdom
        • Royal Gwent Hospital
      • Oxford, United Kingdom
        • Oxford University Hospital
  • United States
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Georgetown University
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Jacksonville
      • Jacksonville, Florida, United States, 32207
        • Jacksonville Center for Clinical Research
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center
      • Boston, Massachusetts, United States, 02214
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital/DFCI
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New York
      • Bronx, New York, United States, 10467
        • Albert Einstein College of Medicine
      • New York, New York, United States, 10021
        • New York-Presbyterian Hospital
      • Staten Island, New York, United States, 10305
        • Staten Island University Hospital/Northwell Health
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Consecutive patients with a newly diagnosed, objectively confirmed: symptomatic or unsuspected, proximal lower-limb DVT or symptomatic PE or unsuspected PE in a segmental or more proximal pulmonary artery;
  • 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:

  • age <18 years;
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apixaban
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Drug: Apixaban
Tablets
Active Comparator: 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
Drug: Dalteparin
Injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrent Venous Thromboembolism
Time Frame: 6 months

Primary efficacy outcome: objectively confirmed recurrent VTE occurring during the study period, that means the composite of:

· proximal DVT of the lower limbs (symptomatic or unsuspected), DVT of the upper limb (symptomatic), PE (symptomatic or unsuspected)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fadoi Foundation, Italy

Collaborators

University Of Perugia

Investigators

  • Study Director: Gualberto Gussoni, MD, FADOI Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 13, 2017

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

January 17, 2017

First Submitted That Met QC Criteria

February 3, 2017

First Posted (Estimated)

February 7, 2017

Study Record Updates

Last Update Posted (Actual)

June 24, 2025

Last Update Submitted That Met QC Criteria

June 20, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FADOI.03.2016

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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.

Clinical Trials on Venous Thromboembolism

Clinical Trials on Apixaban

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uzbekistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe