Apixaban versus Dalteparin for the Treatment of Acute Venous Thromboembolism in Patients with Cancer: The Caravaggio Study
Why the study?
Does apixaban prevent recurrent VTE in patients with cancer and acute VTE compared to dalteparin?
Population
1,168 (planned) patients with cancer and acute proximal deep vein thrombosis and/or pulmonary embolism
Comparison
Oral apixaban 10 mg twice daily for the first 7… vs Subcutaneous dalteparin 200 IU/kg for the first…
Design
RCT, randomized, open-label with blind end-point evaluation (PROBE)
Follow-up
6 months
Authors
Discussion
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Overview
The Caravaggio study protocol outlines a randomized trial to determine if oral apixaban is non-inferior to subcutaneous dalteparin for treating acute VTE in cancer patients.
Key Points
- To determine whether oral apixaban is noninferior to subcutaneous dalteparin for the treatment of acute proximal deep vein thrombosis or pulmonary embolism in patients with cancer.
- Investigator-initiated, multinational, prospective, randomized, open-label trial with blinded endpoint evaluation (PROBE, NCT03045406) designed to randomize 1,168 cancer patients.
- Participants are randomized to receive 6 months of either oral apixaban (10 mg twice daily for 7 days, then 5 mg twice daily) or subcutaneous dalteparin (200 IU/kg daily for 1 month, then 150 IU/kg daily).
- The primary efficacy outcome is objectively confirmed recurrent venous thromboembolism over 6 months, adjudicated by a blinded independent committee.
- Noninferiority is tested assuming a 7% recurrence rate in the dalteparin group and an upper limit of the two-sided 95% confidence interval for the hazard ratio below the margin of 2.00.
- The primary safety outcome evaluates major bleeding defined according to the International Society on Thrombosis and Haemostasis criteria.
Structured PICO
Does apixaban prevent recurrent VTE in patients with cancer and acute VTE compared to dalteparin?
P
Population
1,168 (planned) patients with cancer and acute proximal deep vein thrombosis and/or pulmonary embolism
I
Intervention
Oral apixaban 10 mg twice daily for the first 7 days and then 5 mg twice daily for 6 months
C
Comparator
Subcutaneous dalteparin 200 IU/kg for the first month and then 150 IU/kg once daily for 6 months
O
Outcome
Objectively confirmed recurrent VTE as assessed by a central independent adjudication committee unaware of study treatment allocationhard clinical
The Caravaggio study protocol outlines a randomized trial to determine if oral apixaban is non-inferior to subcutaneous dalteparin for treating acute VTE in cancer patients.
Cite This Study
Agnelli et al. (2018) studied this question.