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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03045406
Recruitment Status : Recruiting
First Posted : February 7, 2017
Last Update Posted : March 6, 2018
University of Perugia, Italy
Information provided by (Responsible Party):
Fadoi Foundation, Italy

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

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Apixaban Drug: Dalteparin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Actual Study Start Date : April 13, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Apixaban
U.S. FDA Resources

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
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

Primary Outcome Measures :
  1. 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)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045406

Contact: Giancarlo Agnelli, MD +390755786424 giancarlo.agnelli@unipg.it
Contact: Cecilia Becattini, MD +390755782311 cecilia.becattini@unipg.it

United States, Massachusetts
Brigham and Women's Hospital/DFCI Not yet recruiting
Boston, Massachusetts, United States, 02115
Contact: Jean Connors         
Cliniques universitaires Saint-Luc Not yet recruiting
Brussels, Belgium
Contact: Catherine Lambert         
Hôpital Europeen Georges Pompidou Recruiting
Paris, France
Contact: Guy Meyer         
Klinikum Darmstadt Not yet recruiting
Darmstadt, Germany
Contact: Rupert Bauersachs         
Rambam Health Care Campus Recruiting
Haifa, Israel
Contact: Benjamin Brenner         
Department of Internal Medicine - University of Perugia Recruiting
Perugia, Italy, 06129
Contact: Giancarlo Agnelli, MD    0039.075.5786424    giancarlo.agnelli@unipg.it   
Contact: Cecilia Becattini, MD    0039.075.5782311    cecilia.becattini@unipg.it   
Leiden University Medical Center Recruiting
Leiden, Netherlands
Contact: Menno Huisman         
Tràs-Os Montes e Alto Douro Recruiting
Vila Real, Portugal
Contact: Miguel Barbosa         
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain
Contact: Andrés Munoz         
United Kingdom
King's College Hospital Recruiting
London, United Kingdom
Contact: Alexander Cohen         
Sponsors and Collaborators
Fadoi Foundation, Italy
University of Perugia, Italy
Study Director: Gualberto Gussoni, MD FADOI Foundation

Responsible Party: Fadoi Foundation, Italy
ClinicalTrials.gov Identifier: NCT03045406     History of Changes
Other Study ID Numbers: FADOI.03.2016
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: March 6, 2018
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Embolism and Thrombosis
Venous Thromboembolism
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents