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The Elderly ACS II Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01777503
Recruitment Status : Unknown
Verified October 2016 by StefanoSavonitto, A. Manzoni Hospital.
Recruitment status was:  Recruiting
First Posted : January 29, 2013
Last Update Posted : October 21, 2016
ANMCO Italian Association of Hospital Cardiologist
Italian Society of Invasive Cardiology
Information provided by (Responsible Party):
StefanoSavonitto, A. Manzoni Hospital

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.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Coronary Arteriosclerosis Myocardial Ischemia Cardiovascular Diseases Drug: prasugrel Drug: Clopidogrel Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : November 2012
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: prasugrel
prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up
Drug: prasugrel
prasugrel 5 mg o.d.
Other Name: Efient

Active Comparator: clopidogrel
Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up
Drug: Clopidogrel
75 mg o.d.
Other Name: Plavix

Primary Outcome Measures :
  1. The composite of all-cause mortality, myocardial infarction (MI), disabling stroke and re-hospitalization for cardiovascular causes or bleeding within one year [ Time Frame: 1 year ]

Secondary Outcome Measures :
  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. [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01777503

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Contact: Stefano Savonitto, MD +39-0341-489490

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Azienda Ospedaliera "Ospedale Civile di Legnano" Recruiting
Legnano, MI, Italy, 20025
Contact: Stefano De Servi, MD   
Principal Investigator: Stefano De Servi, MD         
Arcispedale Santa Maria Nuova- IRCCS Recruiting
Reggio Emilia, Italy, 42123
Contact: Stefano Savonitto, MD    +39-0341-489490   
Principal Investigator: Stefano Savonitto, MD         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
ANMCO Italian Association of Hospital Cardiologist
Italian Society of Invasive Cardiology

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):

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Responsible Party: StefanoSavonitto, dept of division of Cardiology - Manzoni Hospital, A. Manzoni Hospital Identifier: NCT01777503    
Other Study ID Numbers: EudraCT Number: 2012-002882-37
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: October 21, 2016
Last Verified: October 2016
Keywords provided by StefanoSavonitto, A. Manzoni Hospital:
acute coronary syndrome
percutaneous revascularization
antiaggregant drugs
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Pathologic Processes
Heart Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases
Prasugrel Hydrochloride
Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs