Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction
Conditions
Keywords
STEMI, Primary PCI, anticoagulants, antiplatelets
Brief summary
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.
Detailed description
Background: 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 Setting: \- patients presenting with ST-elevation myocardial infarction undergoing primary PCI Mechanical reperfusion: -primary percutaneous coronary intervention Pharmacological Interventions: \- Two arms: Clopidogrel plus heparin/abciximab vs Prasugrel plus Bivalirudin Follow up: \- 1 year Measurements: * efficacy end points in terms of reduction of ischemic events * safety end points in terms of reduction of bleeding events
Interventions
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.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| major adverse cardiovascular events | 1 year | Combined outcome of overall death, non fatal MI, major stroke |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| minor bleedings | 1 year | according to TIMI minor bleedings definition |
| stent thrombosis | 1 year | according to ARC definition of probable/definite stent thrombosis |
| major bleedings | 1 year | according to TIMI major bleedings definition |
| non fatal myocardial infarction | 1 year | defined according to current guidelines |
| ischemic stroke | 1 year | — |
| overall death | 1 year | — |
Countries
Italy