DEVICE
Status
Unknown
Phase
Not applicable
Enrollment
160
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Oct 29, 2013
Study start
Jun 2013
Primary completion
Dec 2016
Study completion
Not reported
Results posted
Not reported
Registry updated
Oct 29, 2013
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
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
Eligibility
Who can take part.
- Minimum age
- Not reported
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
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 locations
1 registered sites.
Italy. Showing up to 24 locations stored in the fast local snapshot.
Misericordia Hospital
Grosseto, Italy, Italy
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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