Acute Coronary Syndrome Clinical Trial
Official title:
Italian Elderly ACS Study
A randomized study comparing an early aggressive with an initially conservative strategy in
patients >74 y.o. with non-ST-elevation acute coronary syndrome.
This study had generated a secondary one:
"Causes of death in elderly patients with Non-ST-Elevation Acute Coronary Syndrome;
predictors of in-hospital and follow-up death"
Patients >74 y.o. with non-ST-elevation acute coronary syndrome will be randomised to an
early aggressive (coronary angiography within 72 hours followed, when indicated, by
revascularization) or an initially conservative strategy (medical therapy, and coronary
angiography only for refractory ischemia).
As reported in Amendment 1, the trial was stopped in May 2010 after the enrolment of 313
patients, which was the minimum sample size calculated in order to achieve a 80% power of
detecting a difference in the primary-endpoint rate from 40% in the conservative arm to 25%
in the invasive arm, based upon the log-rank test for survival curves (1-beta 0.80; 2-tailed
alpha 0.05)
;
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