CARAVAGGIO — Apixaban Versus Dalteparin for Cancer-Associated Venous Thromboembolism (CARAVAGGIO)

Phase 3 · 2020 · Solid Tumors

Design

Randomized open-label noninferiority trial of oral apixaban versus subcutaneous dalteparin for 6 months.

Population

Patients with cancer and newly diagnosed symptomatic or incidental proximal deep-vein thrombosis or pulmonary embolism.

Primary Endpoint

recurrent venous thromboembolism

Key Result

Recurrent VTE 5.6% (apixaban) vs 7.9% (dalteparin) — noninferior (HR 0.63) — with no increase in major bleeding (3.8% vs 4.0%).

Guideline Impact

Supports apixaban as a preferred DOAC option for treating cancer-associated venous thromboembolism (ASCO/ITAC guidance)