The MATRIX OCT Substudy

October 23, 2013 updated by: Andrea Picchi, S.M. Misericordia Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Grosseto, Italy, 58100
        • Recruiting
        • Misericordia Hospital
        • Contact:
          • Ugo Limbruno, MD,PhD, FESC
          • Phone Number: +390564483465
          • Email: ulimbru@tin.it
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
At the end of primary PCI and 4-5 day later

Secondary Outcome Measures

Outcome Measure
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
Time Frame: Athe end of primary PCI and 4/5 days later
Athe end of primary PCI and 4/5 days later

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

S.M. Misericordia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2013

Primary Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

October 18, 2013

First Submitted That Met QC Criteria

October 23, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Estimate)

October 29, 2013

Last Update Submitted That Met QC Criteria

October 23, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MATRIXOCT2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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