The Elderly ACS II Trial

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to compare reduced-dose prasugrel and standard dose clopidogrel in patients older than 74 years with ACS, including non-ST-elevation (NSTEACS) and ST-elevation (STEMI) patients, undergoing early PCI. The primary endpoint of the trial will be the one-year composite of (all-cause)death, myocardial infarction, stroke and re-hospitalization due to cardiovascular reasons or bleeding.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS
• Collaborators: ANMCO Italian Association of Hospital Cardiologist; Italian Society of Invasive Cardiology
• Treatments: Clopidogrel; Prasugrel Hydrochloride; Ticlopidine

Criteria

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.