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

Phase 3

Completed

• Conditions: newly diagnosed proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE); 10014523

• Registration Number: NL-OMON50094
• Lead Sponsor: Fondazione FADOI Italian Federation of Hospital Internists

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 180

Inclusion Criteria

A newly diagnosed, objectively confirmed symptomatic or unsuspected, proximal
lower limb DVTor a symptomatic PE or an unsuspected PE in a segmental or more
proximal pulmonary artery. and any type of cancer (other than basal cell or
squamous cell carcinoma of the skin, primary brain tumors or intracerebral
metastasis and acute leukemia that meets at least one of the following: Active
cancer defined as diagnosis of cancer within 6 months before the study
inclusion, or receiving treatment for cancer at the time of inclusion or any
treatment for cancer during 6 months prior to randomization, or recurrent
locally advanced or metastatic cancer. Cancer diagnosed within 2 years before
the study inclusion (history of cancer).

Exclusion Criteria

less than 18 years of age. ECOG performance status III or IV. Life expectancy
of less than 6 months. Related to anti coagulant therapy: administration of
therapeutic doses of LMWH, fondaparinux, or unfractionated heparin (UFH) for
more than 72 hours before randomization. Three 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 anti coagulant
treatment for a disease other than the index VTE. Concomitant use of strong
inhibitors or inducers of both cytochrome P-450 3A4 and P-Glycoprotein. Related
to bleeding risks: concomitant thienopyridine therapy (clopidogrel, pasugrel or
ticagrelor) or aspirin over 165 mg daily oe dual antiplatlet therapy. Active
bleeding or a high risk of bleeding contraindicating anticoagulant therapy.
`recent (in the last 1 month prior to randomization) brain, spinal or
ophthalmic surgery. Hemoglobin level lower than 8 g/dl (5.0 mmil/Liter or
platelet count less than 75 x 10 to the 9th/L or history of heparin induced
thrombocytopenia. Creatinine clearance less than 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 of of the higher of the upper limit of the
normal range. uncontrolled hypertension (systolic BP more than 180 mm HG or
diastolic BP more than 100 mm Hg despite antihypertensive treatment. Standard
criteria: Bacterial endocarditis, hypersensitivity to the study drugs or to any
of their excipients, patients participating in other pharmacy therapeutic
program with an experimental therapy that is know to effect the coagulation
system, women of child bearing potential (WOCBP) who do not practice a
medically accepted high effective contraception during the trial and one months
beyond, pregnancy or breast feeding, any condition that is judged by the
investigator that would place the subject at increased risk or harm if (s)he
participated in the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified