The Elderly ACS II Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Arcispedale Santa Maria Nuova-IRCCS
Sponsor:
Collaborators:
ANMCO Italian Association of Hospital Cardiologist
Italian Society of Invasive Cardiology
Information provided by (Responsible Party):
StefanoSavonitto, A. Manzoni Hospital
ClinicalTrials.gov Identifier:
NCT01777503
First received: January 21, 2013
Last updated: April 18, 2014
Last verified: April 2014

January 21, 2013
April 18, 2014
November 2012
June 2016   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01777503 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]

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

Same as current
Not Provided
Not Provided
 
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)

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Acute Coronary Syndrome
  • Coronary Arteriosclerosis
  • Myocardial Ischemia
  • Cardiovascular Diseases
  • Drug: prasugrel
    prasugrel 5 mg o.d.
    Other Name: Efient
  • Drug: Clopidogrel
    75 mg o.d.
    Other Name: Plavix
  • Experimental: prasugrel
    prasugrel 60 mg loading dose, followed by 5 mg once daily until the end of follow-up
    Intervention: Drug: prasugrel
  • Active Comparator: clopidogrel
    Clopidogrel 300 mg loading dose followed by 75 mg once day until the end of follow-up
    Intervention: Drug: Clopidogrel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
October 2016
June 2016   (final data collection date for primary outcome measure)

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.
Both
75 Years and older
No
Contact: Stefano Savonitto, MD +39-0341-489490 s.savonitto@ospedale.lecco.it
Italy
 
NCT01777503
EudraCT Number: 2012-002882-37
Yes
StefanoSavonitto, A. Manzoni Hospital
Arcispedale Santa Maria Nuova-IRCCS
  • ANMCO Italian Association of Hospital Cardiologist
  • Italian Society of Invasive Cardiology
Not Provided
Arcispedale Santa Maria Nuova-IRCCS
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP