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

July 31, 2007
February 22, 2012
October 2007
June 2010   (final data collection date for primary outcome measure)
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 ]
The composite of all-cause mortality, myocardial (re)infarction, disabling stroke and re-hospitalization for cardiovascular causes or severe bleeding within six months. [ Time Frame: six months ]
Complete list of historical versions of study NCT00510185 on ClinicalTrials.gov Archive Site
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 ]
CV mortality at 1 yr ;All-causes mortality,myocardial re/infarction at 6 mo and 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 6 mo [ Time Frame: six months to one year ]
Not Provided
Not Provided
 
Early Aggressive Versus Initially Conservative Therapy in Elderly Patients With Non-ST-Elevation Acute Coronary Syndrome
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"

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)

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Coronary Syndrome
  • Other: systematic coronary intervention
    Coronary angiography within 72 hrs
  • Other: coronary intervention only for cases refractory to medical therapy
    Initially conservative treatment with coronary angiography only for recurrent ischemia
  • Experimental: 1
    Coronary angiography within 72h and revascularization as clinical indicated
    Intervention: Other: systematic coronary intervention
  • No Intervention: 2
    Initially conservative treatment with coronary angiography only for recurrent ischemia
    Intervention: Other: coronary intervention only for cases refractory to medical therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
313
June 2011
June 2010   (final data collection date for primary outcome measure)

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.
Both
74 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00510185
Italian Elderly ACS Study
Yes
Niguarda Hospital
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
Niguarda Hospital
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP