Trial | NCT01777503  Report issue

Title

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)

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    2000
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.
Study Started
Nov 30
2012
Primary Completion
Aug 31
2017
Anticipated
Study Completion
Dec 31
2017
Anticipated
Last Update
Oct 21
2016
Estimate

Drug prasugrel

prasugrel 5 mg o.d.

  • Other names: Efient

Drug Clopidogrel

75 mg o.d.

  • Other names: Plavix

prasugrel Experimental

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

clopidogrel Active Comparator

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

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.
No Results Posted