Phase 4
N=52
Pharmacological Effects of Crushing Prasugrel in STEMI Patients
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02212028 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: P2Y12 Reaction Units (PRU) — 95; 164 PRU — p=0.022
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- prasugrel (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY P2Y12 Reaction Units (PRU) |
95; 164 | 0.022 sig |
| SECONDARY Platelet Reactivity Index (PRI) |
33; 61 | 0.005 sig |
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.
Data sourced from ClinicalTrials.gov (NCT02212028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.