Current partner codePEPTIDESDE
NCT01971788·Not applicable·INTERVENTIONAL

The MATRIX OCT Substudy

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.

DEVICE

Optical Coherence Tomography of the infarct related artery

Timeline

From registration to results.

  1. First posted

    Oct 29, 2013

  2. Study start

    Jun 2013

  3. Primary completion

    Dec 2016

  4. Study completion

    Not reported

  5. Results posted

    Not reported

  6. 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.

Primary links

Continue at the source.

Related trials

More studies on Bivalirudin.

Related PeptideStat pages

Put the record in context.

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