The Elderly ACS II Trial

Inclusion criteria

• Patients >74 years of age hospitalized for an ACS, with or without STE, with an onset of symptoms during the previous 72 hours, and candidates to an early PCI.

• STEMI patients may be randomized upon first diagnosis, provided they do not meet any exclusion criteria. STEMI patients should not exceed 50 percent of the global population of the study
• Eligible NSTEACS patients may be randomized after coronary angiography. To be eligible, NSTEACS patients must have at least one of the following characteristics:

• elevated troponin levels;
• diabetes mellitus;
• prior MI;
• at least one new ischemic episode while on standard treatment during the index hospitalization;
• ACS due to stent thrombosis.

Exclusion criteria

• History of stroke or transient ischemic attack (TIA)
• Gastrointestinal or genitourinary bleeding of clinical significance within 6 weeks prior to randomization.
• Hemoglobin level on admission <10 g/dl, unless this is considered to be secondary to renal dysfunction or known myelodysplasia.
• Secondary causes of acute myocardial ischemia.
• Known current platelet count < 90,000 cells/mL.
• Ongoing oral anticoagulant treatment or an INR known to be >1.5 at the time of screening.
• 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.
• Contraindications to the use of clopidogrel or prasugrel as per package leaflet.