- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Andrea Picchi, MD, PhD
- Telefonnummer: +390564483465
- E-post: andre.picchi@gmail.com
Studera Kontakt Backup
- Namn: Ugo Limbruno, MD, PhD, FESC
- Telefonnummer: +390564483465
- E-post: ulimbru@tin.it
Studieorter
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Grosseto, Italien, 58100
- Rekrytering
- Misericordia Hospital
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Kontakt:
- Ugo Limbruno, MD,PhD, FESC
- Telefonnummer: +390564483465
- E-post: ulimbru@tin.it
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Kontakt:
- Andrea Picchi, MD, PhD
- Telefonnummer: +3905644834645
- E-post: andre.picchi@gmail.com
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
---|---|
Change in Minimal Flow Area (MinFA) measured at the end of primary PCI and at 4/5-day follow-up
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Tidsram |
---|---|
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
Tidsram: Athe end of primary PCI and 4/5 days later
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Athe end of primary PCI and 4/5 days later
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MATRIXOCT2013
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