Clinical trial NCT00510185: Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome
Official title: Italian Elderly ACS Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Coronary Syndrome
Keywords: coronary artery disease
coronary angioplasty
coronary artery bypass surgery
elderly
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
Collaborators: name: Italian Society of Cardiology
First posted: 2007-08-01
Enrollment: 313
Sex: ALL
Minimum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Eligibility criteria: Inclusion Criteria:

* Over 74 years of age.
* Have had symptoms suggestive of acute myocardial ischemia at rest within 48 hours prior to randomization, and ischemic ECG changes or elevated levels of biochemical markers of myocardial damage.
* Provide written informed consent before randomization.

Exclusion Criteria:

* Secondary causes of acute myocardial ischemia.
* Ongoing myocardial ischemia despite maximally titrated anti-ischemic therapy (invasive strategy recommended).
* Ongoing signs of acute heart failure despite treatment (invasive strategy recommended).
* Percutaneous coronary intervention or bypass surgery within 30 days prior to randomization.
* A serum creatinine level greater than 2.5 mg/dL.
* Active internal bleeding, history of hemorrhagic diathesis or recent transfusion of red blood cells, whole blood or platelets.
* History of cerebrovascular accident within the previous month.
* Known current platelet count \< 90,000 cells/mL.
* Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
* Concomitant severe obstructive lung disease, malignancy or neurologic deficit limiting follow-up or adherence to the study protocol.
* Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization.
* Inability to give at least verbal informed consent to the study.

Primary outcomes:
measure: The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr.
timeFrame: 1 year
Secondary outcomes:
measure: CV mortality at 1 yr; All-causes mortality, myocardial re/infarction 1 yr; Composite of death, myocardial re/infarction, disabling stroke, rehospitalization due to cardiovascular or clinically bleeding causes at 1 yr; Major bleeding, stroke at 1 yr
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Dept. of Cardiology "A. De Gasperis"
Study officials:
affiliation: Azienda Ospedaliera Ospedale Niguarda Ca' Granda-Dept. of Cardiology "A. De Gasperis"
name: Stefano Savonitto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Cardiology - Ospedale Civile di Legnano - Italy
name: Stefano De Servi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Savonitto S, De Servi S, Petronio AS, Bolognese L, Cavallini C, Greco C, Indolfi C, Visconti LO, Piscione F, Ambrosio G, Galvani M, Marzocchi A, Santilli I, Steffenino G, Maseri A. Early aggressive vs. initially conservative treatment in elderly patients with non-ST-elevation acute coronary syndrome: the Italian Elderly ACS study. J Cardiovasc Med (Hagerstown). 2008 Mar;9(3):217-26. doi: 10.2459/JCM.0b013e3282f7c8df.
citation: Toso A, Servi SD, Leoncini M, Morici N, Murena E, Antonicelli R, Cavallini C, Petronio AS, Steffenino G, Piscione F, Bellandi F, Savonitto S. Acute Kidney Injury in Elderly Patients With Non-ST Elevation Acute Coronary Syndrome: Insights From the Italian Elderly: ACS Study. Angiology. 2015 Oct;66(9):826-30. doi: 10.1177/0003319714567738. Epub 2015 Jan 15.
citation: Savonitto S, Morici N, Cavallini C, Antonicelli R, Petronio AS, Murena E, Olivari Z, Steffenino G, Bonechi F, Mafrici A, Toso A, Piscione F, Bolognese L, De Servi S. One-year mortality in elderly adults with non-ST-elevation acute coronary syndrome: effect of diabetic status and admission hyperglycemia. J Am Geriatr Soc. 2014 Jul;62(7):1297-303. doi: 10.1111/jgs.12900. Epub 2014 Jun 10.
citation: Savonitto S, Cavallini C, Petronio AS, Murena E, Antonicelli R, Sacco A, Steffenino G, Bonechi F, Mossuti E, Manari A, Tolaro S, Toso A, Daniotti A, Piscione F, Morici N, Cesana BM, Jori MC, De Servi S; Italian Elderly ACS Trial Investigators. Early aggressive versus initially conservative treatment in elderly patients with non-ST-segment elevation acute coronary syndrome: a randomized controlled trial. JACC Cardiovasc Interv. 2012 Sep;5(9):906-16. doi: 10.1016/j.jcin.2012.06.008.