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The MATRIX OCT Substudy

Primary Purpose

Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Optical Coherence Tomography of the infarct related artery
Sponsored by
S.M. Misericordia Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Misericordia HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prolonged bivalirudin infusion

Intra-procedural bivalirudin infusion

Arm Description

Bivalirudin infusion is prolonged after the end of primary PCI

Bivalirudin infusion is stopped at the end of primary PCI

Outcomes

Primary Outcome Measures

Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up

Secondary Outcome Measures

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

Full Information

First Posted
October 18, 2013
Last Updated
October 23, 2013
Sponsor
S.M. Misericordia Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01971788
Brief Title
The MATRIX OCT Substudy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
S.M. Misericordia Hospital

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Prolonged bivalirudin infusion
Arm Type
Experimental
Arm Description
Bivalirudin infusion is prolonged after the end of primary PCI
Arm Title
Intra-procedural bivalirudin infusion
Arm Type
Active Comparator
Arm Description
Bivalirudin infusion is stopped at the end of primary PCI
Intervention Type
Device
Intervention Name(s)
Optical Coherence Tomography of the infarct related artery
Primary Outcome Measure Information:
Title
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
Time Frame
At the end of primary PCI and 4-5 day later
Secondary Outcome Measure Information:
Title
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
Time Frame
Athe end of primary PCI and 4/5 days later

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ugo Limbruno, MD, PhD, FESC
Phone
+390564483465
Email
ulimbru@tin.it
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Picchi, MD, PhD
Phone
+390564483465
Email
andre.picchi@gmail.com
Facility Information:
Facility Name
Misericordia Hospital
City
Grosseto
ZIP/Postal Code
58100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ugo Limbruno, MD,PhD, FESC
Phone
+390564483465
Email
ulimbru@tin.it
First Name & Middle Initial & Last Name & Degree
Andrea Picchi, MD, PhD
Phone
+3905644834645
Email
andre.picchi@gmail.com

12. IPD Sharing Statement

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The MATRIX OCT Substudy

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