Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
- Registration Number
- NCT03045406
- Lead Sponsor
- Fadoi Foundation, Italy
- Brief Summary
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1170
- 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.
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Dalteparin 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 Apixaban Apixaban orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
- Primary Outcome Measures
Name Time Method Recurrent Venous Thromboembolism 6 months 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
Name Time Method
Trial Locations
- Locations (127)
University of Southern California
🇺🇸Los Angeles, California, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Florida
🇺🇸Gainesville, Florida, United States
Jacksonville Center for Clinical Research
🇺🇸Jacksonville, Florida, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
Brigham and Women's Hospital/DFCI
🇺🇸Boston, Massachusetts, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Scroll for more (117 remaining)University of Southern California🇺🇸Los Angeles, California, United States