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

March 13, 2019 updated by: Niguarda Hospital

Italian Elderly ACS Study

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"

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

313

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20162
        • Dept. of Cardiology "A. De Gasperis"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

74 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Coronary angiography within 72h and revascularization as clinical indicated
Other: systematic coronary intervention
Coronary angiography within 72 hrs
Sham Comparator: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Niguarda Hospital

Collaborators

Italian Society of Cardiology

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

July 31, 2007

First Submitted That Met QC Criteria

July 31, 2007

First Posted (Estimate)

August 1, 2007

Study Record Updates

Last Update Posted (Actual)

March 15, 2019

Last Update Submitted That Met QC Criteria

March 13, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Italian Elderly ACS Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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