- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Forventet)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Andrea Picchi, MD, PhD
- Telefonnummer: +390564483465
- E-post: andre.picchi@gmail.com
Studer Kontakt Backup
- Navn: Ugo Limbruno, MD, PhD, FESC
- Telefonnummer: +390564483465
- E-post: ulimbru@tin.it
Studiesteder
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Grosseto, Italia, 58100
- Rekruttering
- Misericordia Hospital
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Ta kontakt med:
- Ugo Limbruno, MD,PhD, FESC
- Telefonnummer: +390564483465
- E-post: ulimbru@tin.it
-
Ta kontakt med:
- Andrea Picchi, MD, PhD
- Telefonnummer: +3905644834645
- E-post: andre.picchi@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Prolonged bivalirudin infusion
Bivalirudin infusion is prolonged after the end of primary PCI
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Aktiv komparator: Intra-procedural bivalirudin infusion
Bivalirudin infusion is stopped at the end of primary PCI
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
Tidsramme: At the end of primary PCI and 4-5 day later
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At the end of primary PCI and 4-5 day later
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Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
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
Tidsramme: Athe end of primary PCI and 4/5 days later
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Athe end of primary PCI and 4/5 days later
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MATRIXOCT2013
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