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ALIVE
Azimilide post-Infarct survival Evaluation
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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
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Title(s) |
(a) The Azimilide post-Infarct Survival Evaluation (ALIVE) trial (b) Mortality in patients after a recent myocardial infarction
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Reference(s) |
(a) Am J Cardiol 1998;81:35D–9D (b) Circulation 2004;109:990–6
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Disease |
MI
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Purpose |
To evaluate the effect of azimilide on all-cause mortality in post-MI patients at high risk of sudden cardiac death
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Study design |
Randomised, double-blind, placebo-controlled
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Follow-up |
1 year
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Patients |
3381 patients (1691 azimilide, 1690 placebo), aged 18–80 years, with recent MI (5–21 days) and left ventricular ejection fraction 15–35%
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Treatment regimen |
Azimilide, 100 mg/day, or placebo
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Concomitant therapy |
Beta-blockers, ACE inhibitors, other treatment at the discretion of the physician. Other antiarrhythmics not allowed
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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)
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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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