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Residual thrombosis of stent struts may occur after the end of primary angioplasty and determine distal embolization and further myocardial damage. Bivalirudin is considered the most appropriate antithrombotic drug in the setting of primary PCI, but an initial increase in stent thrombosis has been reported. In order to overcome this potential adverse event, a prolonged infusion of bivalirudin after the end of PCI has been proposed.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prolonged bivalirudin infusion | Experimental | Bivalirudin infusion is prolonged after the end of primary PCI |
|
| Intra-procedural bivalirudin infusion | Active Comparator | Bivalirudin infusion is stopped at the end of primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Optical Coherence Tomography of the infarct related artery | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up | At the end of primary PCI and 4-5 day later |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the number of stent cross sections with a thrombotic area > 10% measured at the end of prymary PCI and at 4/5-day follow-up | Athe end of primary PCI and 4/5 days later |
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Inclusion Criteria:
Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ugo Limbruno, MD, PhD, FESC | Contact | +390564483465 | ulimbru@tin.it | |
| Andrea Picchi, MD, PhD | Contact | +390564483465 | andre.picchi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Misericordia Hospital | Recruiting | Grosseto | Italy | 58100 | Italy |
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