Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00510185
Status:
COMPLETED
Last Update Posted:
2019-03-15
First Post:
2007-07-31
Brief Title:
Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome
Sponsor:
Niguarda Hospital
Organization:
Niguarda Hospital
Study Overview
Official Title:
Italian Elderly ACS Study
Status:
COMPLETED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A randomized study comparing an early aggressive with an initially conservative strategy in patients 74 yo 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
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 yo 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 080 2-tailed alpha 005
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 080 2-tailed alpha 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None