NCT01158846

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 800 (estimated)
• Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• ST-Elevation Myocardial Infarction
• Primary Percutaneous Coronary Intervention

Interventions

Type	Name	Description
DRUG	prasugrel/bivalirudin	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)
DRUG	clopidogrel/abciximab	600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.

Timeline

• Start date: 2010-08-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-07-08
• Last updated: 2010-07-08

Locations

1 site across 1 country: Italy