Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
160 participants
INTERVENTIONAL
2013-06-30
Brief Summary
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This aim of this study is to test whether the use of long-term bivalirudin infusion, as compared to the intra-procedural only administration, reduces residual thrombosis of stent struts evaluated by optical coherence tomography (OCT) at the end of primary PCI and at 3-5 days follow-up.
A subgroup of patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study will be selected showing the following inclusion criteria:
* patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
* patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
* patients whose anatomy is suitable for OCT evaluation.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Prolonged bivalirudin infusion
Bivalirudin infusion is prolonged after the end of primary PCI
Optical Coherence Tomography of the infarct related artery
Intra-procedural bivalirudin infusion
Bivalirudin infusion is stopped at the end of primary PCI
Optical Coherence Tomography of the infarct related artery
Interventions
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Optical Coherence Tomography of the infarct related artery
Eligibility Criteria
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Inclusion Criteria
1. patients affected by STEMI undergoing primary PCI with stent implantation and randomised to bivalirudin treatment,
2. patients who, in addition to the infarct related lesion, show at least one critical stenosis of other coronary vessels suitable for staged-PCI,
3. patients with a coronary anatomy suitable for OCT evaluation.
Exclusion Criteria
ALL
No
Sponsors
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S.M. Misericordia Hospital
OTHER
Responsible Party
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Andrea Picchi
MD, PhD
Locations
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Misericordia Hospital
Grosseto, Italy, Italy
Countries
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Central Contacts
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Facility Contacts
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Ugo Limbruno, MD,PhD, FESC
Role: primary
Andrea Picchi, MD, PhD
Role: backup
Other Identifiers
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MATRIXOCT2013
Identifier Type: -
Identifier Source: org_study_id