Clinical trial NCT01835353: High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Official title: High (100mg) Versus Standard (60mg) Loading Dose of Prasugrel in Patients With ST-elevation Myocardial Infarction (STEMI), Undergoing Primary Percutaneous Coronary Intervention (PCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Platelet Reactivity
Keywords: prasugrel
ST elevation myocardial infarction
Lead sponsor: University of Patras
Sponsor class: OTHER
First posted: 2013-04-18
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a prospective, multi-center, non-randomized, controlled study in 2 sequential groups of P2Y12 inhibitor-naive consecutive STEMI patients undergoing primary PCI. Following aspirin 325 mg LD, patients will receive 60 mg or 100 mg of prasugrel, respectively. Platelet reactivity (PR)will be assessed at Hour 0 (before prasugrel's administration immediately prior to PCI) and at Hours 0.5, 1, 2, 4 thereafter. Platelet function testing (in PRU) will be performed with the VerifyNow (Accumetrics Inc., San Diego, CA, USA) P2Y12 function assay.


Eligibility criteria: Inclusion Criteria:

* ST elevation myocardial infarction
* Pain onset \<12 hours
* Age \>18 and \<75 years
* Written informed consent

Exclusion Criteria:

* history of stroke/transient ischemic attack
* oral anticoagulation
* hemodynamic instability
* platelet count \<100000/μL
* hematocrit \<30%
* creatinine clearance \<30 ml/min
* severe hepatic dysfunction
* active bleeding
* weight \<60 Kg
* periprocedural IIb/IIIa inhibitor administration

Primary outcomes:
measure: Platelet reactivity in Platelet reactivity units (PRU) at Hour 2
timeFrame: 2 hours
Secondary outcomes:
measure: Platelet reactivity in platelet reactivity units (PRU)at hour 1
timeFrame: 1 hour
measure: Platelet reactivity in platelet reactivity units (PRU)at hour 0.5
timeFrame: 0.5 hours
measure: Platelet reactivity in platelet reactivity units (PRU)at hour 4
timeFrame: 4 hours
measure: High platelet reactivity rate (208 PRU threshold) at 0.5 hour
timeFrame: 0.5 hour
measure: High platelet reactivity rate (208 PRU threshold) at 1 hour
timeFrame: 1 hour
measure: High platelet reactivity rate (208 PRU threshold) at 2 hour
timeFrame: 2 hours
measure: High platelet reactivity rate (208 PRU threshold) at 4 hour
timeFrame: 4 hours
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Dimitrios Alexopoulos
state: Achaia
Study officials:
References:
citation: Alexopoulos D, Makris G, Xanthopoulou I, Patsilinakos S, Deftereos S, Gkizas V, Perperis A, Karanikas S, Angelidis C, Tsigkas G, Koutsogiannis N, Hahalis G, Davlouros P. Onset of antiplatelet action with high (100 mg) versus standard (60 mg) loading dose of prasugrel in patients with ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention: pharmacodynamic study. Circ Cardiovasc Interv. 2014 Apr;7(2):233-9. doi: 10.1161/CIRCINTERVENTIONS.113.001118. Epub 2014 Mar 25.