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

Study Overview
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Brief Summary
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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

Detailed Description
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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)

Official Title
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Italian Elderly ACS Study

Conditions
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Acute Coronary Syndrome

Intervention / Treatment
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* Other: systematic coronary intervention
* Other: coronary intervention only for cases refractory to medical therapy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Coronary angiography within 72h and revascularization as clinical indicated | Other: systematic coronary intervention<br>* Coronary angiography within 72 hrs<br>|
| Sham Comparator: 2<br>Initially conservative treatment with coronary angiography only for recurrent ischemia | Other: coronary intervention only for cases refractory to medical therapy<br>* Initially conservative treatment with coronary angiography only for recurrent ischemia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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coronary artery disease, coronary angioplasty, coronary artery bypass surgery, elderly