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

Primary Purpose

Acute Coronary Syndrome

Status

Completed

Phase

Not Applicable

Locations

Italy

Study Type

Interventional

Intervention

systematic coronary intervention

coronary intervention only for cases refractory to medical therapy

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring coronary artery disease, coronary angioplasty, coronary artery bypass surgery, elderly

Eligibility Criteria

74 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Dept. of Cardiology "A. De Gasperis"

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm Description

Coronary angiography within 72h and revascularization as clinical indicated

Initially conservative treatment with coronary angiography only for recurrent ischemia

Outcomes

Primary Outcome Measures

The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr.

Secondary Outcome Measures

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

Full Information

NCT ID

NCT00510185

First Posted

July 31, 2007

Last Updated

March 13, 2019

Sponsor

Niguarda Hospital

Collaborators

Italian Society of Cardiology

1. Study Identification

Unique Protocol Identification Number

NCT00510185

Brief Title

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

2. Study Status

Record Verification Date

March 2019

Overall Recruitment Status

Completed

Study Start Date

October 2007 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Niguarda Hospital

Collaborators

Italian Society of Cardiology

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome

Keywords

coronary artery disease, coronary angioplasty, coronary artery bypass surgery, elderly

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

313 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Coronary angiography within 72h and revascularization as clinical indicated

Arm Title

Arm Type

Sham Comparator

Arm Description

Initially conservative treatment with coronary angiography only for recurrent ischemia

Intervention Type

Other

Intervention Name(s)

systematic coronary intervention

Intervention Description

Coronary angiography within 72 hrs

Intervention Type

Other

Intervention Name(s)

coronary intervention only for cases refractory to medical therapy

Intervention Description

Initially conservative treatment with coronary angiography only for recurrent ischemia

Primary Outcome Measure Information:

Title

The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within 1 yr.

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

74 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefano Savonitto, MD

Organizational Affiliation

Azienda Ospedaliera Ospedale Niguarda Ca' Granda-Dept. of Cardiology "A. De Gasperis"

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Stefano De Servi, MD

Organizational Affiliation

Dept. of Cardiology - Ospedale Civile di Legnano - Italy

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept. of Cardiology "A. De Gasperis"

City

Milan

ZIP/Postal Code

20162

Country

Italy

12. IPD Sharing Statement

Citations:

PubMed Identifier

18301136

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.

Results Reference

background

PubMed Identifier

25593211

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.

Results Reference

derived

PubMed Identifier

24917216

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.

Results Reference

derived

PubMed Identifier

22995877

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.

Results Reference

derived

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

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