Pharmacological Effects of Crushing Prasugrel in STEMI Patients
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; ST Elevation Myocardial Infarction
Intervention: prasugrel
Intervention description: the effects of whole tablets versus crushed tablets will be compared
Intervention MeSH terms: Prasugrel Hydrochloride
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ST-elevation myocardial infarction; prasugrel; pharmacodynamic; pharmacokinetic

Summary:

      Prasugrel has shown to be superior to clopidogrel, in adjunct to aspirin, in preventing
      recurrent ischemic events. Prasugrel is approved in patients with ST-elevation myocardial
      infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at a dosage of
      60 mg loading dose (LD) followed by 10 mg/day. However, a delay in the onset of its
      antiplatelet effects in this particular setting has been consistently shown. administration
      of clopidogrel and ticagrelor crushed tablets has been tested and a faster and greater
      bioavailability compared to the whole tablets has been observed. However, if the
      administration of a crushed prasugrel LD may overcome the above limitation is still unknown
      and represents the aim of our study. The proposed investigation will have a prospective,
      randomized, design in which STEMI patients undergoing primary PCI will be randomized to
      receive two different formulation of prasugrel LD (60 mg whole tablets and 60 mg crushed
      tablets). Pharmacodynamic testing will be performed at several time points to test our study
      hypothesis that crushed LD regiment will achieve more prompt and enhanced platelet inhibitory
      effects.
    

Eligibility criteria:

        Inclusion criteria:

          -  Patients with ST-elevation myocardial infarction undergoing primary PCI

          -  Age between 18 and 75 years old

        Exclusion criteria:

          -  Age >75 years

          -  Weight <60 Kg

          -  On treatment with a P2Y12 receptor antagonist (ticlopidine, clopidogrel, prasugrel,
             ticagrelor) in past 7 days

          -  Known allergies to aspirin or prasugrel

          -  Considered at high risk for bleeding

          -  History of ischemic or hemorrhagic stroke or transient ischemic attack

          -  On treatment with oral anticoagulant (Vitamin K antagonists, dabigatran, rivaroxaban,
             apixaban)

          -  Treatment with IIb/IIIa glycoprotein inhibitors

          -  Fibrinolytics within 24 hours

          -  Known blood dyscrasia or bleeding diathesis

          -  Known platelet count <80x106/mL

          -  Known hemoglobin <10 g/dL

          -  Active bleeding

          -  Hemodynamic instability

          -  Known creatinine clearance <30 mL/minute

          -  Known severe hepatic dysfunction

          -  Pregnant females*

               -  Women of childbearing age must use reliable birth control (i.e. oral
                  contraceptives) while participating in the study.