Clinical trial NCT01777503: The Elderly ACS II 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Coronary Syndrome
Coronary Arteriosclerosis
Myocardial Ischemia
Cardiovascular Diseases
Keywords: acute coronary syndrome
elderly
percutaneous revascularization
antiaggregant drugs
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
Collaborators: name: ANMCO Italian Association of Hospital Cardiologist
name: Italian Society of Invasive Cardiology
name: A. Manzoni Hospital
First posted: 2013-01-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year
timeFrame: 1 year
Secondary outcomes:
measure: 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.
timeFrame: 1 year
Other outcomes:
Locations:
city: Legnano
country: Italy
facility: Azienda Ospedaliera "Ospedale Civile di Legnano"
state: MI
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova- IRCCS
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.