Acute Coronary Syndrome, Cardiovascular Diseases, Coronary Arteriosclerosis, Myocardial Ischemia
Conditions
Keywords
acute coronary syndrome, elderly, percutaneous revascularization, antiaggregant drugs
Brief 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.
Interventions
DRUGprasugrel
prasugrel 5 mg o.d.
DRUGClopidogrel
75 mg o.d.
Sponsors
ANMCO Italian Association of Hospital Cardiologist
Italian Society of Invasive Cardiology
A. Manzoni Hospital
Azienda USL Reggio Emilia - IRCCS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
75 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The composite of burden of recurrent cardiovascular (CV) events, CV mortality, all-cause mortality and MI, major bleeding, any stroke, total number of days spent in hospital. | 1 year | definition of major bleeding: \- Bleeding Academic Research Consortium (BARC) type 2 or 3 bleeding within 1 year (for bleedings occurring during index or subsequent hospitalizations) · BARC type IV bleeding within 1 year |
Countries
Italy
Outcome results
None listed