Pharmacological Effects of Crushing Prasugrel in STEMI Patients

Completed · Phase 4

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID: NCT02212028
Run by: University of Florida
People needed: 52
Starts: 2014-10-01
Expected to finish: 2015-08-01
Last updated by the study team: 2016-12-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Patients with ST-elevation myocardial infarction undergoing primary PCI
Age between 18 and 75 years old

You may not qualify if…

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.

Where it is running

University of Florida — Jacksonville, Florida, United States

Full record on ClinicalTrials.gov

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