Study Design

Study Design:

Patients Screened: 4,800
Patients Enrolled: 1,202
Mean Follow Up: 1.79 years
Mean Patient Age: 64
Female: Amiodarone = 21%; placebo = 22%

Patient Populations:

Acute myocardial infarction (MI) within the previous 6-45 days based on the presence of two of three of the following criteria:
Characteristic ischemic pain in the precordium or associated referral areas for at least 20 minutes during physical and emotional rest.
Activities of creatine kinase or aspartate aminotransferase >2 times the upper limit or the presence of creatine kinase MB of 6% or more than that of the total activity of creatinine kinase [MB is a measurement of creatine phosphokinase isoenzyme MB bands of cardiac muscle].
Development of new 40 ms Q-waves in at least two adjacent ECG leads or the development of a dominant R-wave in V1 (R >1 mm and S >1 mm in V1).
10 or more VPDs /h or more (>18 h of monitoring required) or at least one run of ventricular tachycardia (VT) on 24-h electrographic recording (>3 beats at a rate of 100-200/min, or 3-10 beats at a rate >120/min).
Age > 19 years.

Exclusions:

Contraindications to amiodarone (previous intolerance or current therapy, waking bradycardia, sustained heart rate >50/min, PR interval of 220 ms or more, first-, second- or third-degree atrioventricular block, prolonged QTC interval (>480 ms), moderate or severe peripheral neuropathy, chronic or acute hepatitis, suggestion of interstitial fibrosis on chest radiographs, clinical hyperthyroidism or hypothyroidism or current therapy for these conditions).
Requirement of antiarrhythmic therapy (run of VT for 6 beats or more and rate of 100 bpm or more, atrial or ventricular arrhythmia that in the opinion of the treating physician required antiarrhythmic drugs other than β-blockers or digoxin), tricyclic antidepressant drugs, sotalol or phenytoin.
Medical factors (NYHA class IV congestive heart failure, CCVS class IV angina, severe hypotension, uncorrected hypokalemia, noncardiac illness likely to shorten survival significantly to less than two years, and women of childbearing potential).
Geographic or social factors making study participation impractical.
Astha.

Primary Endpoints:

Composite of resuscitated ventricular fibrillation or arrhythmic death

Secondary Endpoints:

Arrhythmic death
Cardiac death
All-cause mortality

Drug/Procedures Used:

Amiodarone: loading dose 10 mg/kg/day to the nearest 100 mg for 3 weeks, adjusted as required for drug intolerance or potentially serious side effects
Maintenance dose: 300- 400 mg/day depending on body weight, adjusted to reflect Holter monitor results.
If arrhythmia suppression was detected, the dose of amiodarone or placebo was reduced to 200-300 mg daily at month 4 and to 200 mg for 5 or 7 days per week at month 8. If arrhythmia suppression was not detected on repeat ambulatory ECG, the dose was not reduced. The duration of treatment was 24 months.

Concomitant Medications:

β-blocker
Calcium channel antagonists
Digoxin
Thrombolytic agents
Warfarin
Aspirin
ACE inhibitor