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ALIVE
Azimilide post-Infarct survival Evaluation
Author(s)
(a) Camm AJ, Karam R, Pratt CM
(b) Camm AJ, Pratt CM, Schwartz PJ, Al-Khalidi HR, Spyt MJ, Holroyde MJ, Karam R, Sonnenblick EH, Brum JMG
Title(s)
(a) The Azimilide post-Infarct Survival Evaluation (ALIVE) trial
(b) Mortality in patients after a recent myocardial infarction
Reference(s)
(a) Am J Cardiol 1998;81:35D–9D
(b) Circulation 2004;109:990–6
Disease
MI
Purpose
To evaluate the effect of azimilide on all-cause mortality in post-MI patients at high risk of sudden cardiac death
Study design
Randomised, double-blind, placebo-controlled
Follow-up
1 year
Patients
3381 patients (1691 azimilide, 1690 placebo), aged 18–80 years, with recent MI (5–21 days) and left ventricular ejection fraction 15–35%
Treatment regimen
Azimilide, 100 mg/day, or placebo
Concomitant therapy
Beta-blockers, ACE inhibitors, other treatment at the discretion of the physician. Other antiarrhythmics not allowed
Results
There was no significant difference between the groups in the incidence of all-cause mortality (11.6% in each group). In the 1264 patients (622 azimilide, 642 placebo) at high risk of sudden cardiac death (defined as heart rate variability ≤ 20 U), the incidence of all-cause mortality was 14.1% in the azimilide group and 15.0% in the placebo group (p = ns)
Comments
The initial study design included three treatment arms (azimilide, 75 or 100 mg/day, or placebo), but the azimilide 75 mg arm was discontinued because of enrolment difficulties
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