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

Primary Purpose

Venous Thromboembolism

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Apixaban
Dalteparin
Sponsored by
Fadoi Foundation, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Venous Thromboembolism

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Southern California
  • Georgetown University
  • University of Florida
  • Jacksonville Center for Clinical Research
  • Mayo Clinic Jacksonville
  • Emory University
  • Brigham and Women's Hospital/DFCI
  • Massachusetts General Hospital
  • Beth Israel Deaconess Medical Center
  • Mayo Clinic
  • Dartmouth Hitchcock Medical Center
  • Albert Einstein College of Medicine
  • New York-Presbyterian Hospital
  • Staten Island University Hospital/Northwell Health
  • University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • Ohio State University
  • University of Texas M.D. Anderson Cancer Center
  • Cliniques universitaires Saint-Luc
  • KU Leuven
  • Hôpital Privé Arras Les Bonnettes
  • CHU Bordeaux Hôpital Saint André
  • Hopital Cavale Blanche
  • Hôpital des armées HIA Clermont Tonnerre
  • Centre Hospitalier Universitaire de Clermont-Ferrand
  • Hôpital Louis Mourier
  • Centre Hospitalier Universitaire Dijon Bourgogne
  • Centre Hospitalier Universitaire Grenoble Alpes
  • CH de Vendée Centre Hospitalier Départemental
  • Centre Hospitalier Emile Roux Le Puy-en-Velay
  • Université de Limoges
  • Centre Hospitalier Universitaire Lyon-Sud
  • Hopital Pasteur - Chu de Nice
  • Hôpital Europeen Georges Pompidou
  • Université Jean Monnet
  • Hôpital Sainte Musse
  • Klinikum Darmstadt
  • Städtisches Klinikum Dresden-Friedrichstadt
  • Universitäts GefäßCentrum (UGC)
  • Universitätskrankenhaus Hamburg-Eppendorf
  • Forschungszentrum Ruhr
  • Haemek Medical Center
  • Soroka University Medical Center
  • Rambam Health Care Campus
  • Meir Medical Center
  • Galilee Medical Center
  • Rabin Medical Center
  • AOU Ospedali Riuniti di Ancona
  • AOSG Moscati
  • Ospedale Sacro Cuore di Gesù Fatebenefratelli
  • ASST Papa Giovanni XXIII
  • Ospedale Maggiore
  • Ospedale San Giacomo Apostolo
  • Ospedale di Cosenza
  • Ospedale SS Annunziata
  • AOU Careggi
  • AOU San Martino
  • AOU di Modena
  • AO di Rilievo Nazione Antonio Cardarelli
  • Istituto Nazionale Tumori - IRCCS Fondazione Pascale
  • Ospedale Buon Consiglio Fatebenefratelli
  • Ospedale San Martino
  • Azienda Ospedaliera di Padova
  • AO Ospedali Riuniti Villa Sofia
  • Department of Internal Medicine - University of Perugia
  • Ospedale SS Cosma e Damiano
  • Ospedale di Piacenza
  • AOU Pisana
  • Ospedale di Pitigliano
  • Ospedale di Ravenna
  • Arcispedale S. Maria Nuova
  • Ospedale San Giovanni Calibita Fatebenefratelli
  • Policlinico Agostino Gemelli
  • Ospedale S. Paolo
  • AO Santa Maria
  • Ospedale Cà Foncello
  • Ospedale di Udine
  • AO Ospedale di Circolo e Fondazione Macchi
  • Ospedale Sacro Cuore-Don Calabria di Negrar-Verona.
  • Ospedale San Bortolo
  • Ziekenhuisgroep Twente ZGT
  • Academic Medical Centre
  • Rijnstate Arnhem
  • Rode Kruis Ziekenhuis Beverwijk
  • Amphia Hospital Breda
  • Haaglanden Hospital Den Haag
  • Slingeland Doetinchem
  • Albert Schweitzer ziekenhuis
  • Medisch Spectrum Twente
  • Leiden University Medical Center
  • Erasmus MC
  • HagaZiekenhuis
  • Szpital Brzozów
  • Świetokrzyskie Centrum Onkologii
  • Opolskie Centrum Onkologii
  • Medical Centre for Postgraduate Education - ECZ-Otwock
  • CMKP
  • Wielkoposkie Centrum Onkologii
  • IPO Lisboa
  • IPO Porto
  • Tràs-Os Montes e Alto Douro
  • Hospital Torrecardenas
  • Hospital Sant Pau
  • Hospital Val d'Hebron
  • Sabadell Hospital
  • Fundación Jiménez Díaz
  • Hospital 12 de Octubre
  • Hospital Clara Campal
  • Hospital Clínico San Carlos
  • Hospital Fuenlabrada
  • Hospital General Universitario Gregorio Marañón
  • Hospital Infanta Leonor
  • Hospital La Paz
  • Hospital Puerta de Hierro
  • Hospital Ramón y Cajal
  • Hospital Morales Meseguer
  • Hospital de Málaga
  • Hospital Central de Asturias
  • Clínica Universitaria de Navarra
  • Hospital Marqués Valdecilla
  • Hospital Virgen del Rocio
  • Hospital Clínico Lozano Blesa
  • University Hospitals Bristol
  • University Hospital of Wales
  • King's College Hospital
  • Royal Gwent Hospital
  • Oxford University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Apixaban

Dalteparin

Arm Description

orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Full Information

First Posted
January 17, 2017
Last Updated
November 13, 2019
Sponsor
Fadoi Foundation, Italy
Collaborators
University Of Perugia
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1. Study Identification

Unique Protocol Identification Number
NCT03045406
Brief Title
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
Acronym
CARAVAGGIO
Official Title
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 13, 2017 (Actual)
Primary Completion Date
June 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fadoi Foundation, Italy
Collaborators
University Of Perugia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Venous Thromboembolism

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1168 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apixaban
Arm Type
Experimental
Arm Description
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Arm Title
Dalteparin
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Apixaban
Intervention Description
Tablets
Intervention Type
Drug
Intervention Name(s)
Dalteparin
Intervention Description
Injections
Primary Outcome Measure Information:
Title
Recurrent venous thromboembolism
Description
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)
Time Frame
6 months

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
34382385
Citation
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.
Results Reference
derived
PubMed Identifier
34260816
Citation
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.
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PubMed Identifier
32223112
Citation
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.
Results Reference
derived

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Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

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