The MATRIX OCT Substudy

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by S.M. Misericordia Hospital
Sponsor:
Information provided by (Responsible Party):
Andrea Picchi, S.M. Misericordia Hospital
ClinicalTrials.gov Identifier:
NCT01971788
First received: October 18, 2013
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.

Condition Intervention
Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy
Device: Optical Coherence Tomography of the infarct related artery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by S.M. Misericordia Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

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 [ Time Frame: Athe end of primary PCI and 4/5 days later ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: June 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01971788

Contacts
Contact: Ugo Limbruno, MD, PhD, FESC +390564483465 ulimbru@tin.it
Contact: Andrea Picchi, MD, PhD +390564483465 andre.picchi@gmail.com

Locations
Italy
Misericordia Hospital Recruiting
Grosseto, Italy, 58100
Contact: Ugo Limbruno, MD,PhD, FESC    +390564483465    ulimbru@tin.it   
Contact: Andrea Picchi, MD, PhD    +3905644834645    andre.picchi@gmail.com   
Sponsors and Collaborators
S.M. Misericordia Hospital
  More Information

No publications provided

Responsible Party: Andrea Picchi, MD, PhD, S.M. Misericordia Hospital
ClinicalTrials.gov Identifier: NCT01971788     History of Changes
Other Study ID Numbers: MATRIXOCT2013
Study First Received: October 18, 2013
Last Updated: October 23, 2013
Health Authority: Italy: Ethics Committee

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis
Bivalirudin
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anticoagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 20, 2014