Clinical trial NCT01158846: Bivalirudin/Prasugrel Versus Abciximab/Clopidogrel in Patients Presenting With STEMI
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: ST-Elevation Myocardial Infarction
Primary Percutaneous Coronary Intervention
Keywords: STEMI
Primary PCI
anticoagulants
antiplatelets
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
Collaborators: name: Centro Cardiologico Monzino
name: Azienda Ospedaliera Niguarda Cà Granda
name: Istituto Clinico Humanitas
First posted: 2010-07-08
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: major adverse cardiovascular events
timeFrame: 1 year
Secondary outcomes:
measure: major bleedings
timeFrame: 1 year
measure: minor bleedings
timeFrame: 1 year
measure: stent thrombosis
timeFrame: 1 year
measure: overall death
timeFrame: 1 year
measure: non fatal myocardial infarction
timeFrame: 1 year
measure: ischemic stroke
timeFrame: 1 year
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Istituto Clinico S. Ambrogio
Study officials:
affiliation: Istituto Clinico S. Ambrogio
name: Luca Testa, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Clinico S. Ambrogio
name: Fracensco Bedogni, MD
role: STUDY_DIRECTOR
References:
citation: Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
citation: Mehran R, Lansky AJ, Witzenbichler B, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Kornowski R, Hartmann F, Gersh BJ, Pocock SJ, Wong SC, Nikolsky E, Gambone L, Vandertie L, Parise H, Dangas GD, Stone GW; HORIZONS-AMI Trial Investigators. Bivalirudin in patients undergoing primary angioplasty for acute myocardial infarction (HORIZONS-AMI): 1-year results of a randomised controlled trial. Lancet. 2009 Oct 3;374(9696):1149-59. doi: 10.1016/S0140-6736(09)61484-7. Epub 2009 Aug 28.