Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer: A Prospective Randomized Open Blinded End-Point (Probe) Study
Overview
- Phase
- Phase 3
- Intervention
- Apixaban
- Conditions
- Venous Thromboembolism
- Sponsor
- Fadoi Foundation, Italy
- Enrollment
- 1170
- Locations
- 127
- Primary Endpoint
- Recurrent Venous Thromboembolism
- Status
- Completed
- Last Updated
- 10 months ago
Overview
Brief Summary
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
Investigators
Eligibility Criteria
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;
Arms & Interventions
Apixaban
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Intervention: Apixaban
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
Intervention: Dalteparin
Outcomes
Primary Outcomes
Recurrent Venous Thromboembolism
Time Frame: 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)