The MATRIX OCT Substudy

Study Overview
=================
Brief Summary
-----------------
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: 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.

Conditions
-----------------
Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

Intervention / Treatment
-----------------
* Device: Optical Coherence Tomography of the infarct related artery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features: 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 with a coronary anatomy suitable for OCT evaluation. Exclusion Criteria: The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prolonged bivalirudin infusion<br>Bivalirudin infusion is prolonged after the end of primary PCI | Device: Optical Coherence Tomography of the infarct related artery<br> <br> |
| Active Comparator: Intra-procedural bivalirudin infusion<br>Bivalirudin infusion is stopped at the end of primary PCI | Device: Optical Coherence Tomography of the infarct related artery<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |