The MATRIX OCT Substudy

NCT01971788 | Unknown

• 1 other identifier: MATRIXOCT2013
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Prolonged bivalirudin infusion

EXPERIMENTAL

Bivalirudin infusion is prolonged after the end of primary PCI

Device: Optical Coherence Tomography of the infarct related artery

Intra-procedural bivalirudin infusion

ACTIVE COMPARATOR

Bivalirudin infusion is stopped at the end of primary PCI

Device: Optical Coherence Tomography of the infarct related artery

Interventions

Optical Coherence Tomography of the infarct related artery DEVICE

Intra-procedural bivalirudin infusion; Prolonged bivalirudin infusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• S.M. Misericordia Hospital: lead

Study Sites (1)

Misericordia Hospital

Grosseto, Italy, 58100, Italy

RECRUITING

Central Study Contacts

Ugo Limbruno, MD, PhD, FESC

CONTACT

+390564483465; ulimbru@tin.it

Andrea Picchi, MD, PhD

CONTACT

+390564483465; andre.picchi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 29, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Last Updated: October 29, 2013

Record last verified: 2013-10

Locations

IT (1)