The Elderly ACS II Trial

Cardiovascular Diseases Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01777503
• Other study ID #: EudraCT Number: 2012-002882-37
• Status: Recruiting
• Phase: Phase 4
• First received: January 21, 2013
• Last updated: October 19, 2016
• Start date: November 2012
• Est. completion date: December 2017

Study information

• Verified date: October 2016
• Source: Arcispedale Santa Maria Nuova-IRCCS
• Contact: Stefano Savonitto, MD
• Phone: +39-0341-489490
• Email: s.savonitto[@]ospedale.lecco.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: December 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Arteriosclerosis
• Cardiovascular Diseases
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Syndrome

Intervention

Drug:
• prasugrel
prasugrel 5 mg o.d.
• Clopidogrel
75 mg o.d.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera "Ospedale Civile di Legnano"	Legnano	MI
Italy	Arcispedale Santa Maria Nuova- IRCCS	Reggio Emilia

Sponsors (3)

Lead Sponsor	Collaborator
Arcispedale Santa Maria Nuova-IRCCS	ANMCO Italian Association of Hospital Cardiologist, Italian Society of Invasive Cardiology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year		1 year	Yes
Secondary	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	Yes

External Links

•   Design and rationale of the randomized Elderly-ACS 2 study