Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

More Details

Status
Unknown status
Sponsor
Fadoi Foundation, Italy

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.