Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study (MASTER)
3. juli 2018 opdateret af: Terumo Europe N.V.
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
The aim of the study is to demonstrate the safety and efficacy of the TCD-10023 (Ultimaster) sirolimus eluting stent in patients with acute ST-elevation myocardial infarction (STEMI), by proving superiority with respect to in-stent late loss at 6 months to the Kaname bare metal stent and non-inferiority with respect to Target Vessel Failure (TVF) at 12 months.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
MASTER is prospective, randomized (3:1), single blind, controlled, superiority (efficacy) and non-inferiority (safety and efficacy), multi center, two-arm trial of TCD-10023 (Ultimaster) drug eluting stent (test) and Kaname bare metal stent (comparator).
Patients will be followed at 30 days, 6, and 12 months post-procedure and annually for 3 years.
500 patients with clinical follow up will be randomized in 3:1 ratio (375 in TCD-10023 arm and 125 in Kaname arm). Among them, 100 patients will be randomized in the same, 3:1 ratio, to angiographic follow up at 6 months in preselected hospitals (75 in TCD-10023 and 25 in Kaname arm)
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
500
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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São Paulo, Brasilien
- Instituto Dante Pazzanese
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Catania, Italien
- Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
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Florence, Italien, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italien
- San Raffaele Hospital
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Milan, Italien
- Cardiologico Monzino
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Skopje, Makedonien, Den Tidligere Jugoslaviske Republik, 1000
- PHE University Cardiology clinic
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Belgrade, Serbien
- Clinical Center of Serbia
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Belgrade, Serbien
- Clinical Hospital Center Zemun (CHC Zemun)
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Nis, Serbien
- Clinical center Nis (CCNIs)
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A Coruña, Spanien
- Complejo Hospitalario Universitario A Coruna
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El Palmar, Spanien
- Hospital Universitario Virgen Arrixaca-Murcia
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Oviedo, Spanien
- Hospital Universitario Central Asturias-Oviedo
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Santiago de Compostela, Spanien
- Complejo Hospitalario Universitario Santiago de Compostela
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age equal or more than 18 years
- Chest pain > 20 minutes
- Primary PCI <24h from symptoms onset
- ST-segment elevation of > 1 mm in > 2 contiguous leads, or (presumably new) left bundle branch block, or true posterior MI with ST depression of > 1 mm in > 2 contiguous anterior leads
- Presence of at least one acute infarct artery target vessel with one or more coronary artery stenoses in a native coronary artery from 2.5-4.0 mm in diameter that can be covered with one or multiple stents
- Signed informed consent
Exclusion Criteria:
- Female of childbearing potential (age < 50 and last menstruation within the last 12 months), who did not underwent tubal ligation, ovariectomy or hysterectomy
- Known intolerance to aspirin, clopidogrel, heparin, bivalirudin, cobalt, chromium, nickel, sirolimus or contrast material
- Currently participating in another trial before reaching primary endpoint
- Mechanical complication of acute myocardial infarction (e.g. cardiogenic shock…)
- Acute myocardial infarction secondary to stent thrombosis
- Previously stented infarction related artery (IRA)
- Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period
- Patients with non-cardiac comorbid conditions with life expectancy< 1 year or that may result in protocol non-compliance
- History of bleeding diathesis or known coagulopathy
- Use of oral anticoagulants
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Ultimaster, Drug Eluting Stent
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
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Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Andre navne:
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Andre navne:
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Aktiv komparator: Kaname, Bare metal stent
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
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Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Andre navne:
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Target Vessel Failure (TVF)
Tidsramme: 12 months
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Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
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12 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Target lesion failure
Tidsramme: 1 month, 6 months, 12 months, 2 and 3 years
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Composite of cardiac death, target vessel myocardial infarction, target lesion revascularization 2. Target vessel failure (TVF) Comosite of cardiac death, target vessel myocardial infarction, target lesion revascularization
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1 month, 6 months, 12 months, 2 and 3 years
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Target vessel failure
Tidsramme: 1 month, 6 months, 2 and 3 years
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Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
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1 month, 6 months, 2 and 3 years
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Stent thrombosis
Tidsramme: 1 month, 6 months, 12 months, 2 and 3 years
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Thrombosis in study stents
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1 month, 6 months, 12 months, 2 and 3 years
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Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Tidsramme: 1 month, 6 months, 12 months, 2 and 3 years
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Composite of any death, any myocardial infarction, any coronary revascularization
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1 month, 6 months, 12 months, 2 and 3 years
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Target lesion revascularization
Tidsramme: 1 month, 6 months, 12 months, 2 and 3 years
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revascularization of treated lesion
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1 month, 6 months, 12 months, 2 and 3 years
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Bleeding
Tidsramme: 1 month, 6 months, 12 months, 2 and 3 years
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Access or non access site bleeding
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1 month, 6 months, 12 months, 2 and 3 years
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Safety - revascularization, stroke, definite stent thrombosis or major bleeding
Tidsramme: 1 month
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revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
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1 month
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In-Stent late loss
Tidsramme: 6-mnths
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angiographic assessment of late loss at 6 months
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6-mnths
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Vladimir Borovicanin, MD, Terumo Europe
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2013
Primær færdiggørelse (Faktiske)
1. juli 2016
Studieafslutning (Faktiske)
1. maj 2018
Datoer for studieregistrering
Først indsendt
16. maj 2013
Først indsendt, der opfyldte QC-kriterier
11. juli 2016
Først opslået (Skøn)
12. juli 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juli 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. juli 2018
Sidst verificeret
1. juli 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- T120E4
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