drugset / Trial / NCT05335928

Abatacept in Immune Checkpoint Inhibitor Myocarditis

NCT05335928

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.

Timeline

Start
2022-07-02
Primary completion
2026-11-20
Completion
2027-04-20

Drugs

EvaluationDrugModalityDoseRoute
Subject Abatacept Other / unclassified 10 mg/kg Intravenous