The Elderly ACS II Trial (NCT01777503) | Clinical Trial Compass
CompletedPhase 4
The Elderly ACS II Trial
Italy1,457 participantsStarted 2012-11
Plain-language 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.
Who can participate
Age range75 Years
SexALL
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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…
What they're measuring
1
The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year