drugset / Trial / NCT06835491

Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

NCT06835491

Phase 3 Recruiting 674 enrolled Versailles Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Timeline

Start
2025-11-06
Primary completion
2027-01-15
Completion
2027-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Amiodarone Small molecule 10 mg/kg