PRASUGREL TAB
Clinical Criteria Summary
Exclusion Criteria
- Active pathologic bleeding
- Clinically important anemia or thrombocytopenia
- History of prior transient ischemic attack (TIA), stroke, or intracranial hemorrhage (ICH)
- Body weight less than 60 kg
- Age 75 or older unless at high risk of ischemic events (e.g., diabetes mellitus or prior myocardial infarction) and otherwise low bleeding risk
- Planned or recent fibrinolytic therapy (e.g., within past 24 hours)
- Concomitant anticoagulant therapy (clopidogrel is preferred P2Y12 inhibitor for use in combination with an oral anticoagulant)
- Severe hepatic impairment
- Anticipated urgent coronary artery bypass graft (CABG) surgery (e.g., within 7 days)
Inclusion Criteria
- ST-elevation myocardial infarction acute coronary syndrome (STEMI-ACS) and undergoing PCI
- Non-ST elevation ACS with planned PCI after coronary anatomy identified and deemed suitable for PCI, ischemic symptoms lasting ≥10 min and occurring within 72 hrs of presentation, TIMI risk score of ≥3, and either ST segment deviation of ≥1 mm or positive cardiac biomarkers
- Definite or probable acute stent thrombosis (Academic Research Consortium definition) in patients documented to be compliant with aspirin and clopidogrel
- Reduced clopidogrel response (e.g., any documented CYP2C19 intermediate or poor metabolizer phenotypes or high on-treatment platelet reactivity by P2Y12 reaction units [PRU] testing) and continued indication for P2Y12 inhibitor therapy
- Extended duration dual antiplatelet therapy (DAPT=aspirin plus P2Y12 inhibitor) beyond 12 months following an ACS event as per Cardiology re-evaluation
- Undergoing PCI with or without ACS in patients with clopidogrel allergy or true aspirin allergy
Dosing and Duration Considerations
- If no other antiplatelet is appropriate, standard dose prasugrel may be considered but is associated with no net clinical benefit in patients 75 and older or who weigh less than 60 kg; alternatively, the lower dose of 5 mg of prasugrel daily may be considered
- Extended durations of therapy: DAPT for at least 12 months is guideline recommended therapy after ACS; longer or shorter durations may be considered with the understanding that DAPT reduces ischemic risk but increases bleeding risk
- Routine pharmacogenomic or platelet function screening for reduced clopidogrel response is not currently guideline recommended, and the ultimate clinical benefit of a guided-use strategy is unknown