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The Elderly ACS II Trial | Clinical Trials | Clareo Health

COMPLETEDPHASE4

The Elderly ACS II Trial

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

NCT01777503•Azienda USL Reggio Emilia - IRCCS

View on ClinicalTrials.gov

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.

Eligibility

Age

75 - No limit years

Sex

ALL

Healthy Volunteers

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.

Exclusion Criteria

•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.
•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.
+6 more criteria

Locations (2)

Arcispedale Santa Maria Nuova- IRCCS

Reggio Emilia, Italy, Italy

Azienda Ospedaliera "Ospedale Civile di Legnano"

Legnano, MI, Italy

Key Dates

Start Date

November 1, 2012

Primary Completion Date

January 25, 2017

Completion Date

December 19, 2017

Last Updated

June 24, 2025

Enrollment

1,457

ACTUAL participants

Conditions

Acute Coronary SyndromeCoronary ArteriosclerosisMyocardial IschemiaCardiovascular Diseases

Interventions

prasugrel

DRUG

Clopidogrel

DRUG

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

NCT07436429

Myocardial Infarction (MI)ST-Elevation Myocardial Infarction+3 more

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RECRUITINGNA

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

NCT07429227

Acute Coronary Syndromes (ACS)

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Elderly ACS II Trial

Inclusion Criteria

Exclusion Criteria

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

Revascularization Strategies in Patients With Non-ST-Segment Elevation Acute Coronary Syndrome (NSTE-ACS) and Severe Coronary Artery Disease

MACT (Mono Antiplatelet and Colchicine Therapy) Prospective Multicenter Study

Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)

A Polypill for Acute Coronary Syndrome