The Elderly ACS II Trial

Study Overview
=================
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.

Official Title
-----------------
Phase IV: A Comparison of Reduced-dose Prasugrel and Clopidogrel in Elderly Patients With Acute Coronary Syndrome Undergoing Early Percutaneous Coronary Intervention (PCI)

Conditions
-----------------
Acute Coronary Syndrome, Coronary Arteriosclerosis, Myocardial Ischemia, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Drug: prasugrel
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: prasugrel<br>prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up | Drug: prasugrel<br>* prasugrel 5 mg o.d.<br>* Other names: Efient;|
| Active Comparator: clopidogrel<br>Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up | Drug: Clopidogrel<br>* 75 mg o.d.<br>* Other names: Plavix;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute coronary syndrome, elderly, percutaneous revascularization, antiaggregant drugs