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

This study has been completed.
Sponsor:
Collaborator:
Italian Society of Cardiology
Information provided by (Responsible Party):
Niguarda Hospital
ClinicalTrials.gov Identifier:
NCT00510185
First received: July 31, 2007
Last updated: February 22, 2012
Last verified: February 2012
  Purpose

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 Intervention
Acute Coronary Syndrome
Other: systematic coronary intervention
Other: coronary intervention only for cases refractory to medical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Italian Elderly ACS Study

Further study details as provided by Niguarda Hospital:

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. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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 [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Enrollment: 313
Study Start Date: October 2007
Study Completion Date: June 2011
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   74 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00510185

Locations
Italy
Dept. of Cardiology "A. De Gasperis"
Milan, Italy, 20162
Sponsors and Collaborators
Niguarda Hospital
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
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Niguarda Hospital
ClinicalTrials.gov Identifier: NCT00510185     History of Changes
Other Study ID Numbers: Italian Elderly ACS Study
Study First Received: July 31, 2007
Last Updated: February 22, 2012
Health Authority: Italy: Ministry of Health

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

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on October 23, 2014