Venous thromboembolism in cancer patients
Conditions
Interventions
Product Name: Apixaban
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: APIXABAN
CAS Number: 503612-47-3
Other descriptive name: apixaban
Concentration unit: mg milligram(s)
Concentration
Sponsors
FONDAZIONE FADOI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) 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. 2) Any type of cancer (other than basal-cell or squamous-cell carcinoma of the skin, primary brain tumor or known intracerebral metastases and acute leukemia) that meets at least one of the following: • Active cancer defined as diagnosis of cancer within six 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). 3) Signed and dated informed consent, available before the start of any specific trial procedure. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 818 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 350
Exclusion criteria
Exclusion criteria: 1) Age 180 mm Hg or diastolic BP > 100 mm Hg despite antihypertensive treatment); Standard criteria: 16) Bacterial endocarditis; 17) Hypersensitivity to the study drugs or to any of their excipients; 18) Patients participation in other pharmaco therapeutic program with an experimental therapy that is known to effect the coagulation system. 19) Women of childbearing potential (WOCBP) who do not practice a medically accepted highly effective contraception during the trial and one month beyond. Highly effective contraception methods are: a. combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation b. progestogen-only hormonal contraception associated with inhibition of ovulation c. intrauterine device (IUD) d. intrauterine hormone-releasing system (IUS) e. bilateral tubal occlusion f. vasectomized partner g. sexual abstinence ; 20) Pregnancy, or breast feeding 21) Any condition that, as judged by the investigator, would place the subject at increased risk of harm if he/she participated in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this study is to assess whether apixaban is non-inferior to the LMWH dalteparin for the treatment of newly diagnosed proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in patients with cancer.;Secondary Objective: Not applicable;Primary end point(s): 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 Primary safety outcome is major bleeding, defined (as per ISTH guidelines), as acute clinically overt bleeding.;Timepoint(s) of evaluation of this end point: 7 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary efficacy outcomes: • The individual components of the primary efficacy outcome; • Symptomatic recurrence of VTE; • All cause death; • The composite of primary efficacy outcome plus major bleeding; • The composite of primary efficacy outcome plus major bleeding plus all cause death; • The composite of primary efficacy outcome plus all cause death; • Any major cardiovascular event, fatal or non-fatal (including acute myocardial infarction or ischemic stroke); • All venous thromboembolic events (including splanchnic vein thrombosis and cerebral vein thrombosis); • Quality of life (QoL) according to Anti-Clot Treatment Scale (ACTS) (see Appendix 2) ;Timepoint(s) of evaluation of this end point: 7 months | — |
Countries
Israel, Netherlands, Portugal, Spain, United Kingdom
Contacts
Public ContactGualberto Gussoni
Fondazione FADOI
Outcome results
None listed