Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
Purpose
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
Condition
- Venous Thromboembolism
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
Arm | Description | Assigned 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) |
|
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 |
|
More Details
- Status
- Unknown status
- Sponsor
- Fadoi Foundation, Italy