The Elderly ACS II Trial

Azienda USL Reggio Emilia - IRCCS

Status and phase: Completed; Phase 4

Conditions: Myocardial Ischemia; Acute Coronary Syndrome; Coronary Arteriosclerosis; Cardiovascular Diseases

Treatments: Drug: Clopidogrel; Drug: prasugrel

Study type: Interventional

Funder types: Other

Identifiers

NCT01777503

EudraCT Number: 2012-002882-37

Details and patient eligibility

About

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.

Enrollment: 1,457 patients

Sex: All

Ages: 75+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,457 participants in 2 patient groups

prasugrel

Experimental group

Description:

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

Treatment:

Drug: prasugrel

clopidogrel

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel