Phase 3
Completed N=1,170
Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
Source: ClinicalTrials.gov NCT03045406 ↗Enrolled (actual)
1,170
Serious AEs
46.0%
Results posted
Jun 2025
Primary outcomePrimary: Recurrent Venous Thromboembolism — 32; 46 Participants
◆ Published Evidence
Highly cited
1,037citations · ~173 / year
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.
Summary
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
Linked Publications (3)
-
Apixaban for the Treatment of Venous Thromboembolism Associated with Cancer.
-
Clinical characteristics and outcomes of incidental venous thromboembolism in cancer patients: Insights from the Caravaggio study.
-
Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrent Venous Thromboembolism |
32; 46 | — |
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 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.
Data sourced from ClinicalTrials.gov (NCT03045406) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.