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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01158846
Enrollment
800
Registered
2010-07-08
Start date
2010-08-31
Completion date
2011-06-30
Last updated
2010-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Percutaneous Coronary Intervention, ST-Elevation Myocardial Infarction

Keywords

STEMI, Primary PCI, anticoagulants, antiplatelets

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

Interventions

DRUGprasugrel/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)

DRUGclopidogrel/abciximab

600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.

Sponsors

Centro Cardiologico Monzino
CollaboratorOTHER
Azienda Ospedaliera Niguarda Cà Granda
CollaboratorOTHER
Istituto Clinico Humanitas
CollaboratorOTHER
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
major adverse cardiovascular events1 yearCombined outcome of overall death, non fatal MI, major stroke

Secondary

MeasureTime frameDescription
minor bleedings1 yearaccording to TIMI minor bleedings definition
stent thrombosis1 yearaccording to ARC definition of probable/definite stent thrombosis
major bleedings1 yearaccording to TIMI major bleedings definition
non fatal myocardial infarction1 yeardefined according to current guidelines
ischemic stroke1 year
overall death1 year

Countries

Italy

Contacts

Primary ContactLuca Testa, MD, PhD
luctes@gmail.com+39-3490808660

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026