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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00510185
Recruitment Status : Completed
First Posted : August 1, 2007
Last Update Posted : February 23, 2012
Italian Society of Cardiology
Information provided by (Responsible Party):
Niguarda Hospital

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"

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Other: systematic coronary intervention Other: coronary intervention only for cases refractory to medical therapy Not Applicable

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)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 313 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Italian Elderly ACS Study
Study Start Date : October 2007
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: 1
Coronary angiography within 72h and revascularization as clinical indicated
Other: systematic coronary intervention
Coronary angiography within 72 hrs
No Intervention: 2
Initially conservative treatment with coronary angiography only for recurrent ischemia
Other: coronary intervention only for cases refractory to medical therapy
Initially conservative treatment with coronary angiography only for recurrent ischemia

Primary Outcome Measures :
  1. 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 Measures :
  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 [ Time Frame: 1 year ]

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Ages Eligible for Study:   74 Years and older   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00510185

Dept. of Cardiology "A. De Gasperis"
Milan, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
Italian Society of Cardiology
Principal Investigator: 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

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Niguarda Hospital Identifier: NCT00510185     History of Changes
Other Study ID Numbers: Italian Elderly ACS Study
First Posted: August 1, 2007    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012

Keywords provided by Niguarda Hospital:
coronary artery disease
coronary angioplasty
coronary artery bypass surgery

Additional relevant MeSH terms:
Acute Coronary Syndrome
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases