Status:
COMPLETED
Pharmacological Effects of Crushing Prasugrel in STEMI Patients
Lead Sponsor:
University of Florida
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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) und...
Detailed Description
Dual antiplatelet therapy consisting of aspirin and a P2Y12 receptor antagonist is the cornerstone of treatment for prevention of thrombotic events in patients with acute coronary syndromes (ACS). Pra...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT02212028
Start Date
October 1 2014
End Date
August 1 2015
Last Update
December 28 2016
Active Locations (1)
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1
University of Florida
Jacksonville, Florida, United States, 32209