Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
Bivalirudin Plus Prasugrel vs Abciximab Plus Clopidogrel. Optimizing Ischemic Protection and Bleeding Risk in Patients With ST Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention
Lead SponsorIstituto Clinico Sant'Ambrogio
Indication/ConditionST-Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention
Intervention/Treatmentabciximab prasugrel bivalirudin clopidogrel ...
In the setting of ST elevation myocardial infarction newer therapies has been recently studied and, following encouraging results, introduced into the clinical practice. Prasugrel showed to be a valid alternative to overcome limitation of clopidogrel therefore providing a better ischemic protection. On the other hand, bivalirudin is at least as beneficial as heparin/abciximab as anticoagulant agent but associated with fewer hemorrhagic events. The primary hypothesis of the study is that the combination of prasugrel plus bivalirudin can be associated with a better risk/benefit profile.
In the setting of STEMI, adjunctive pharmacological therapy plays a key role in the acute management. Along with the clear benefit of mechanical reperfusion strategies, several drugs showed to be beneficial. On top of clopidogrel, heparins and IIB/IIIa glycoprotein, other drugs have been recently introduced showing encouraging results. These "new" drugs, namely prasugrel and bivalirudin, have only been compared separately.
Primary hypothesis: the combination of prasugrel/bivalirudin is superior to the combination of clopidogrel and heparin/abciximab in terms of net adverse clinical events, i.e. ischemic events plus hemorrhagic events
- patients presenting with ST-elevation myocardial infarction undergoing primary PCI
-primary percutaneous coronary intervention
- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin
- 1 year
efficacy end points in terms of reduction of ischemic events
safety end points in terms of reduction of bleeding events
60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion)
600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.
60 mg loading dose of prasugrel will be followed by maintenance dose of 10mg (or 5mg according to body weight and age). During primary PCI, Bivalirudin will be used as anticoagulant (bolus plus infusion), on a weight-adjusted dose.
600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant.
Inclusion Criteria: ST elevation myocardial infarction No contraindication to primary PCI Exclusion Criteria: Known intolerance/allergy to one of the study drugs or their components Clinical indication to treatment with oral anticoagulant, including use of warfarin or dabigatran or other oral anticoagulant agents