Overview

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.