ST-segment Elevation Myocardial Infarction Clinical Trial
Official title:
Rapid Activity of Platelet Inhibitor Drugs Study
The aim of the RAPID study is to assess the rapid onset of action of the 2 novel oral antiplatelet agents, Prasugrel and Ticagrelor, in 50 patients with STEMI undergoing PPCI with bivalirudin monotherapy.
Fifty consecutive patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not
allowed ) will be randomized to receive 60 mg Prasugrel loading dose (n= 25) or 180
Ticagrelor loading dose (n= 25) before PPCI. The loading dose will be performed as soon as
possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after
drug loading dose a new loading dose will be administered. All interventions will be
performed by the femoral approach according to current standards. The use of thrombectomy
before infarct-related artery stenting, of everolimus eluting stent and of closure devices
will be strongly encouraged. Bivalirudin will be administered as a bolus 0.75 mg/kg followed
by 1.75 mg/kg/h infusion during PCI. After PCI a reduced bivalirudin infusion of 0.25
mg/kg/h for 4 hours will be allowed. Dual antiplatelet therapy (100 mg aspirin associated
with 5 or 10 mg Prasugrel or 180 mg Ticagrelor) will be recommended for 12 months.
Residual platelet reactivity will be assessed in all patients at baseline (time of loading
dose), and after 2, 4, 8 and 12 hours by a point-of-care test VerifyNow bedside available in
the Intensive cardiac care Unit. High residual platelet reactivity will be defined as a
Platelet Reactivity Units (PRU) > 240 by VerifyNow. At the same time point, Activated
Clotting Time (ACT) will be also assessed. Follow-up will be performed by outpatient visits
or telephone interviews at 6 months.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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