The Elderly ACS II Trial

NCT01777503 | Completed Phase 4 DMC

• 1 other identifier: EudraCT Number: 2012-002882-37
• Study Type: interventional
• Target: 1,457
• Locations: 1 country
• Sites: 2

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.

Conditions

Acute Coronary Syndrome; Coronary Arteriosclerosis; Myocardial Ischemia; Cardiovascular Diseases

Keywords

acute coronary syndrome; elderly; percutaneous revascularization; antiaggregant drugs

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

prasugrel

EXPERIMENTAL

prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up

Drug: prasugrel

clopidogrel

ACTIVE COMPARATOR

Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up

Drug: Clopidogrel

Interventions

prasugrel DRUG

prasugrel 5 mg o.d.

Also known as: Efient

prasugrel

Clopidogrel DRUG

75 mg o.d.

Also known as: Plavix

clopidogrel

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Azienda USL Reggio Emilia - IRCCS: lead
• ANMCO Italian Association of Hospital Cardiologist: collaborator
• Italian Society of Invasive Cardiology: collaborator
• A. Manzoni Hospital: collaborator

Study Sites (2)

Arcispedale Santa Maria Nuova- IRCCS

Reggio Emilia, Italy, 42123, Italy

Location

Azienda Ospedaliera "Ospedale Civile di Legnano"

Legnano, MI, 20025, Italy

Location

Related Publications (3)

• Crimi G, Morici N, Ferrario M, Ferri LA, Piatti L, Grosseto D, Cacucci M, Mandurino Mirizzi A, Toso A, Piscione F, De Carlo M, Elia LR, Trimarco B, Bolognese L, Bovenzi FM, De Luca G, Savonitto S, De Servi S. Time Course of Ischemic and Bleeding Burden in Elderly Patients With Acute Coronary Syndromes Randomized to Low-Dose Prasugrel or Clopidogrel. J Am Heart Assoc. 2019 Jan 22;8(2):e010956. doi: 10.1161/JAHA.118.010956.

  PMID: 30636561 DERIVED

• Savonitto S, Ferri LA, Piatti L, Grosseto D, Piovaccari G, Morici N, Bossi I, Sganzerla P, Tortorella G, Cacucci M, Ferrario M, Murena E, Sibilio G, Tondi S, Toso A, Bongioanni S, Ravera A, Corrada E, Mariani M, Di Ascenzo L, Petronio AS, Cavallini C, Vitrella G, Rogacka R, Antonicelli R, Cesana BM, De Luca L, Ottani F, De Luca G, Piscione F, Moffa N, De Servi S; Elderly ACS 2 Investigators. Comparison of Reduced-Dose Prasugrel and Standard-Dose Clopidogrel in Elderly Patients With Acute Coronary Syndromes Undergoing Early Percutaneous Revascularization. Circulation. 2018 Jun 5;137(23):2435-2445. doi: 10.1161/CIRCULATIONAHA.117.032180. Epub 2018 Feb 19.

  PMID: 29459361 DERIVED

• Ferri LA, Morici N, Grosseto D, Tortorella G, Bossi I, Sganzerla P, Cacucci M, Sibilio G, Tondi S, Toso A, Ferrario M, Gandolfo N, Ravera A, Mariani M, Corrada E, Di Ascenzo L, Petronio AS, Cavallini C, Moffa N, De Servi S, Savonitto S. A comparison of reduced-dose prasugrel and standard-dose clopidogrel in elderly patients with acute coronary syndromes undergoing early percutaneous revascularization: Design and rationale of the randomized Elderly-ACS 2 study. Am Heart J. 2016 Nov;181:101-106. doi: 10.1016/j.ahj.2016.08.010. Epub 2016 Aug 26.

  PMID: 27823681 DERIVED

Related Links

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

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases

Interventions

Prasugrel Hydrochloride; Clopidogrel

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ticlopidine; Thienopyridines; Pyridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2013
• First Posted: January 29, 2013
• Study Start: November 1, 2012
• Primary Completion: January 25, 2017
• Study Completion: December 19, 2017
• Last Updated: June 24, 2025

Record last verified: 2016-10

Locations

IT (2)