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Phase 3 N=1,170 Randomized Treatment

Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer

Venous Thromboembolism

Enrolled (actual)
1,170
Serious AEs
46.0%
Results posted
Jun 2025
Primary outcome: Primary: Recurrent Venous Thromboembolism — 32; 46 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Apixaban (Drug); Dalteparin (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Fadoi Foundation, Italy
Primary completion
Jun 2019

Outcome Measures

OutcomeResultp-value
PRIMARY
Recurrent Venous Thromboembolism
32; 46

Summary

Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03045406). 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.

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