NCT00510185

Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome

Italian Elderly ACS Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 313 (actual)
• Sponsor: Niguarda Hospital · Academic / Other
• Sex: All
• Age: 74 Years
• Healthy volunteers: Not accepted

Summary

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"

Detailed description

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)

Conditions

• Acute Coronary Syndrome

Interventions

Type	Name	Description
OTHER	systematic coronary intervention	Coronary angiography within 72 hrs
OTHER	coronary intervention only for cases refractory to medical therapy	Initially conservative treatment with coronary angiography only for recurrent ischemia

Timeline

• Start date: 2007-10-01
• Primary completion: 2010-06-01
• Completion: 2011-06-01
• First posted: 2007-08-01
• Last updated: 2019-03-15

Locations

1 site across 1 country: Italy