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
  Purpose

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 Intervention Phase
Acute Coronary Syndrome
Coronary Arteriosclerosis
Myocardial Ischemia
Cardiovascular Diseases
Drug: prasugrel
Drug: Clopidogrel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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)

Resource links provided by NLM:


Further study details as provided by Arcispedale Santa Maria Nuova-IRCCS:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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



Estimated Enrollment: 2000
Study Start Date: November 2012
Estimated Study Completion Date: October 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   75 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777503

Contacts
Contact: Stefano Savonitto, MD +39-0341-489490 s.savonitto@ospedale.lecco.it

Locations
Italy
Azienda Ospedaliera "Ospedale Civile di Legnano" Recruiting
Legnano, MI, Italy, 20025
Contact: Stefano De Servi, MD       stefano.deservi@ao-legnano.it   
Principal Investigator: Stefano De Servi, MD         
Arcispedale Santa Maria Nuova- IRCCS Recruiting
Reggio Emilia, Italy, 42123
Contact: Stefano Savonitto, MD    +39-0341-489490    s.savonitto@ospedale.lecco.it   
Principal Investigator: Stefano Savonitto, MD         
Sponsors and Collaborators
Arcispedale Santa Maria Nuova-IRCCS
ANMCO Italian Association of Hospital Cardiologist
Italian Society of Invasive Cardiology
  More Information

No publications provided

Responsible Party: StefanoSavonitto, dept of division of Cardiology - Manzoni Hospital, A. Manzoni Hospital
ClinicalTrials.gov Identifier: NCT01777503     History of Changes
Other Study ID Numbers: EudraCT Number: 2012-002882-37
Study First Received: January 21, 2013
Last Updated: April 18, 2014
Health Authority: Italy: Ethics Committee

Keywords provided by Arcispedale Santa Maria Nuova-IRCCS:
acute coronary syndrome
elderly
percutaneous revascularization
antiaggregant drugs

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Ischemia
Acute Coronary Syndrome
Arterial Occlusive Diseases
Vascular Diseases
Coronary Disease
Heart Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms
Clopidogrel
Prasugrel
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014