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

NCT01158846 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2010-07-08

No results posted yet for this study

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.

Conditions

  • ST-Elevation Myocardial Infarction
  • Primary Percutaneous Coronary Intervention

Interventions

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.

Sponsors & Collaborators

  • Centro Cardiologico Monzino

    collaborator OTHER

  • Azienda Ospedaliera Niguarda Cà Granda

    collaborator OTHER

  • Istituto Clinico Humanitas

    collaborator OTHER

  • I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

    lead OTHER

Principal Investigators

  • Luca Testa, MD,PhD · Istituto Clinico S. Ambrogio

  • Fracensco Bedogni, MD · Istituto Clinico S. Ambrogio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01158846 on ClinicalTrials.gov