The Elderly ACS II Trial

Phase 4

• Conditions: Acute Coronary Syndrome; Coronary Arteriosclerosis; Myocardial Ischemia; Cardiovascular Diseases
• Interventions: Drug: prasugrel; Drug: Clopidogrel

• Registration Number: NCT01777503
• Lead Sponsor: Arcispedale Santa Maria Nuova-IRCCS

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-21
• Study First Submitted QC: 2013-01-24
• Study First Posted: 2013-01-29
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21
• Primary Completion: 2017-08
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prasugrel	prasugrel	prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up
clopidogrel	Clopidogrel	Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (2)

Azienda Ospedaliera "Ospedale Civile di Legnano"; 🇮🇹 Legnano, MI, Italy

Arcispedale Santa Maria Nuova- IRCCS; 🇮🇹 Reggio Emilia, Italy