- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01971788
The MATRIX OCT Substudy
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
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Andrea Picchi, MD, PhD
- Phone Number: +390564483465
- Email: andre.picchi@gmail.com
Study Contact Backup
- Name: Ugo Limbruno, MD, PhD, FESC
- Phone Number: +390564483465
- Email: ulimbru@tin.it
Study Locations
-
-
-
Grosseto, Italy, 58100
- Recruiting
- Misericordia Hospital
-
Contact:
- Ugo Limbruno, MD,PhD, FESC
- Phone Number: +390564483465
- Email: ulimbru@tin.it
-
Contact:
- Andrea Picchi, MD, PhD
- Phone Number: +3905644834645
- Email: andre.picchi@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
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
|
|
Active Comparator: Intra-procedural bivalirudin infusion
Bivalirudin infusion is stopped at the end of primary PCI
|
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
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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