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

October 18, 2013
October 23, 2013
June 2013
December 2016   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01971788 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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The MATRIX OCT Substudy
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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.
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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy
Device: Optical Coherence Tomography of the infarct related artery
  • Experimental: Prolonged bivalirudin infusion
    Bivalirudin infusion is prolonged after the end of primary PCI
    Intervention: 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
    Intervention: Device: Optical Coherence Tomography of the infarct related artery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
Not Provided
December 2016   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Ugo Limbruno, MD, PhD, FESC +390564483465 ulimbru@tin.it
Contact: Andrea Picchi, MD, PhD +390564483465 andre.picchi@gmail.com
Italy
 
NCT01971788
MATRIXOCT2013
Not Provided
Andrea Picchi, S.M. Misericordia Hospital
S.M. Misericordia Hospital
Not Provided
Not Provided
S.M. Misericordia Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP