Study Design

Study Design:

Patients Screened: 2,083
Patients Enrolled: 1,073
Mean Follow Up: 6 months
Female: 12

Patient Populations:

MI within 24 hours

Exclusions:

Follow-up not feasible, systolic blood pressure <100 mm Hg, heart rate <60 beats per minute, second or third degree atrioventricular block, intraventricular conduction blocks, corrected QT intervals >500 ms, severe heart failure, supraventricular or ventricular arrhythmias requiring amiodarone therapy, clinically significant liver disease, presence of other diseases affecting short-term survival, women who were pregnant or nursing or suspected of child-bearing, epilepsy with uncontrolled seizures, psychiatric condition likely to limit cooperation, hypersensitivity to amiodarone, amiodarone therapy within the last three months, or current or previous significant thyroid dysfunction

Primary Endpoints:

All-cause mortality at six months

Secondary Endpoints:

Sudden death, heart failure death, reinfarction death, development or progression of heart failure, postinfarction angina, reinfarction, nonfatal arrhythmias, and rehospitalization

Drug/Procedures Used:

Eligible patients were randomized to receive amiodarone or placebo in a double-blind fashion as soon as possible after onset of symptoms or immediately after fibrinolytic administration in patients who received it. Initially, patients in the amiodarone group received a loading dose of 2400 mg intravenously (IV) over 48 hours, as well as an oral dose of 600 mg every 12 hours for four days, followed by 400 mg per day on days 5 though 90 and 200 mg per day thereafter.

After enrollment of 516 patients, an interim analysis revealed higher mortality in patients receiving amiodarone. Consequently, the dose of amiodarone was decreased to 1200 mg IV with an oral dose of 800 mg per day in one dose for the first 48 hours, followed by an oral dose of 400 mg per day on days 3 through 90 and 200 mg per day thereafter.