Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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ST-Elevation Myocardial Infarction, Primary Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: prasugrel/bivalirudin
* Drug: clopidogrel/abciximab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: prasugrel/bivalirudin<br>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. | Drug: prasugrel/bivalirudin<br>* 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)<br>* Other names: Angiox;|
| Active Comparator: clopidogrel/abciximab<br>600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant. | Drug: clopidogrel/abciximab<br>* 600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.<br>* Other names: ReoPro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major adverse cardiovascular events | Combined outcome of overall death, non fatal MI, major stroke | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major bleedings | according to TIMI major bleedings definition | 1 year | 
| minor bleedings | according to TIMI minor bleedings definition | 1 year | 
| stent thrombosis | according to ARC definition of probable/definite stent thrombosis | 1 year | 
| overall death |  | 1 year | 
| non fatal myocardial infarction | defined according to current guidelines | 1 year | 
| ischemic stroke |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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STEMI, Primary PCI, anticoagulants, antiplatelets