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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1170

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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
        • Hopital Europeen 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 Marañon
      • 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 Clinico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fadoi Foundation, Italy

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Of Perugia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 13, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 17, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2017

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings