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

ST-Elevation Myocardial Infarction Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Primary Percutaneous Coronary Intervention
• ST-Elevation Myocardial Infarction

• NCT number: NCT01158846
• Study type: Interventional
• Source: Istituto Clinico Sant'Ambrogio
• Contact: Luca Testa, MD, PhD
• Phone: +39-3490808660
• Email: luctes@gmail.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: August 2010
• Completion date: June 2011