Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Venous Thromboembolism Clinical Trial

— CARAVAGGIO  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03045406
• Other study ID #: FADOI.03.2016
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: April 13, 2017
• Est. completion date: December 1, 2019

Study information

• Verified date: November 2019
• Source: Fadoi Foundation, Italy
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1168
• Est. completion date: December 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Thromboembolism
• Venous Thromboembolism

Intervention

Drug:
• Apixaban
Tablets
• Dalteparin
Injections

Locations

Country	Name	City	State
Belgium	Cliniques universitaires Saint-Luc	Brussels
Belgium	KU Leuven	Leuven
France	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-Étienne
France	Hôpital Sainte Musse	Toulon
Germany	Klinikum Darmstadt	Darmstadt
Germany	Städtisches Klinikum Dresden-Friedrichstadt	Dresden
Germany	Universitäts GefäßCentrum (UGC)	Dresden
Germany	Universitätskrankenhaus Hamburg-Eppendorf	Hamburg
Germany	Forschungszentrum Ruhr	Witten
Israel	Haemek Medical Center	Afula
Israel	Soroka University Medical Center	Be'er Sheva
Israel	Rambam Health Care Campus	Haifa
Israel	Meir Medical Center	Kfar Saba
Israel	Galilee Medical Center	Nahariya
Israel	Rabin Medical Center	Petah Tikva
Italy	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	Firenze
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	Padova
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
Netherlands	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	Haaglanden Hospital Den Haag	Den Haag
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	HagaZiekenhuis	the Hague
Poland	Szpital Brzozów	Brzozów
Poland	Swietokrzyskie Centrum Onkologii	Kielce
Poland	Opolskie Centrum Onkologii	Opole
Poland	CMKP	Otwock
Poland	Medical Centre for Postgraduate Education - ECZ-Otwock	Otwock
Poland	Wielkoposkie Centrum Onkologii	Poznan
Portugal	IPO Lisboa	Lisboa
Portugal	IPO Porto	Porto
Portugal	Tràs-Os Montes e Alto Douro	Vila Real
Spain	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	Sevilla
Spain	Hospital Clínico Lozano Blesa	Zaragoza
United Kingdom	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 States	Emory University	Atlanta	Georgia
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital/DFCI	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Albert Einstein College of Medicine	Bronx	New York
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Ohio State University	Columbus	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	University of Florida	Gainesville	Florida
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	Jacksonville Center for Clinical Research	Jacksonville	Florida
United States	Mayo Clinic Jacksonville	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Southern California	Los Angeles	California
United States	New York-Presbyterian Hospital	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	Staten Island University Hospital/Northwell Health	Staten Island	New York
United States	Georgetown University	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Fadoi Foundation, Italy	University of Perugia, Italy

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Israel,  Italy,  Netherlands,  Poland,  Portugal,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent venous thromboembolism	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