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

NCT00510185 | Completed DMC

• 1 other identifier: Italian Elderly ACS Study
• Study Type: interventional
• Target: 313
• Locations: 1 country
• Sites: 1

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"

Conditions

Acute Coronary Syndrome

Keywords

coronary artery disease; coronary angioplasty; coronary artery bypass surgery; elderly

Outcome Measures

Primary Outcomes (1)

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

  1 year

Secondary Outcomes (1)

• 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

  1 year

Study Arms (2)

1

EXPERIMENTAL

Coronary angiography within 72h and revascularization as clinical indicated

Other: systematic coronary intervention

2

SHAM COMPARATOR

Initially conservative treatment with coronary angiography only for recurrent ischemia

Other: coronary intervention only for cases refractory to medical therapy

Interventions

systematic coronary intervention OTHER

Coronary angiography within 72 hrs

1

coronary intervention only for cases refractory to medical therapy OTHER

Initially conservative treatment with coronary angiography only for recurrent ischemia

2

Eligibility Criteria

• Age: 74 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Niguarda Hospital: lead
• Italian Society of Cardiology: collaborator

Study Sites (1)

Dept. of Cardiology "A. De Gasperis"

Milan, 20162, Italy

Location

Related Publications (4)

• 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.

  PMID: 18301136 BACKGROUND

• 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.

  PMID: 25593211 DERIVED

• 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.

  PMID: 24917216 DERIVED

• 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.

  PMID: 22995877 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Stefano Savonitto, MD

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

  PRINCIPAL INVESTIGATOR

• Stefano De Servi, MD

  Dept. of Cardiology - Ospedale Civile di Legnano - Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2007
• First Posted: August 1, 2007
• Study Start: October 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2011
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

IT (1)