The MATRIX OCT Substudy

Not Applicable

• Conditions: Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy
• Interventions: Device: Optical Coherence Tomography of the infarct related artery

• Registration Number: NCT01971788
• Lead Sponsor: S.M. Misericordia Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Status Verified: 2013-10
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-23
• Last Update Submitted: 2013-10-23
• Study First Posted: 2013-10-29
• Last Update Posted: 2013-10-29
• Primary Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

• Patients enrolled in the MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study showing the following features:

  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

• The same criteria used in MATRIX (Minimizing Adverse haemmhorragic events by TRansradial access site and AngioX study) study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intra-procedural bivalirudin infusion	Optical Coherence Tomography of the infarct related artery	Bivalirudin infusion is stopped at the end of primary PCI
Prolonged bivalirudin infusion	Optical Coherence Tomography of the infarct related artery	Bivalirudin infusion is prolonged after the end of primary PCI

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Misericordia Hospital; 🇮🇹 Grosseto, Italy