Acute Myocardial Infarction, Coronary Stent Thrombosis, Antithrombotic Therapy Clinical Trial
| NCT number | NCT01971788 |
| Other study ID # | MATRIXOCT2013 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | October 18, 2013 |
| Last updated | October 23, 2013 |
| Start date | June 2013 |
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.
| Status | Recruiting |
| Enrollment | 160 |
| Est. completion date | |
| Est. primary completion date | December 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Italy | Misericordia Hospital | Grosseto |
| Lead Sponsor | Collaborator |
|---|---|
| S.M. Misericordia Hospital |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No | |
| Secondary | 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 | No |