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

Phase 4

• Conditions: ST-Elevation Myocardial Infarction; Primary Percutaneous Coronary Intervention
• Interventions: Drug: prasugrel/bivalirudin; Drug: clopidogrel/abciximab

• Registration Number: NCT01158846
• Lead Sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

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

Study Timeline

• Status Verified: 2010-06
• Study First Submitted: 2010-06-25
• Study First Submitted QC: 2010-07-07
• Last Update Submitted: 2010-07-07
• Study First Posted: 2010-07-08
• Last Update Posted: 2010-07-08
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
prasugrel/bivalirudin	prasugrel/bivalirudin	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.
clopidogrel/abciximab	clopidogrel/abciximab	600mg loading dose of clopidogrel will be followed by 75mg maintenance dose. During primary PCI abciximab (bolus plus infusion) will be used as anticoagulant.

Primary Outcome Measures

Name	Time	Method
major adverse cardiovascular events	1 year	Combined outcome of overall death, non fatal MI, major stroke

Secondary Outcome Measures

Name	Time	Method
major bleedings	1 year	according to TIMI major bleedings definition
minor bleedings	1 year	according to TIMI minor bleedings definition
stent thrombosis	1 year	according to ARC definition of probable/definite stent thrombosis
overall death	1 year
non fatal myocardial infarction	1 year	defined according to current guidelines
ischemic stroke	1 year

Trial Locations

Locations (1)

Istituto Clinico S. Ambrogio; 🇮🇹 Milan, Italy