Apixaban for the Treatment of Venous Thromboembolism in Patients With Cancer
(CARAVAGGIO Trial)
Recruiting in Palo Alto (17 mi)
+126 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Fadoi Foundation, Italy
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 2 Jurisdictions
Trial Summary
What is the purpose of this trial?
Apixaban for the treatment of venous thromboembolism in patients with cancer: a prospective randomized open blinded end-point (PROBE) study
Research Team
GG
Gualberto Gussoni, MD
Principal Investigator
FADOI Foundation
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.
Treatment Details
Interventions
- Apixaban (Anticoagulant)
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: ApixabanExperimental Treatment1 Intervention
orally administered, at the dose of 10 mg bid for 7 days, followed by 5 mg bid (total period of treatment: six months)
Group II: DalteparinActive Control1 Intervention
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Fadoi Foundation, Italy
Lead Sponsor
Trials
16
Recruited
18,100+
University Of Perugia
Collaborator
Trials
83
Recruited
87,300+
Marco Malvestiti
University Of Perugia
Chief Executive Officer since 2015
PhD in Chemical Science, University of Perugia
Paolo Gresele
University Of Perugia
Chief Medical Officer since 2015
MD, University of Perugia
University of Perugia, Italy
Collaborator
Trials
1
Recruited
1,200+