- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT02828683
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study (MASTER)
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
Aperçu de l'étude
Statut
Les conditions
Description détaillée
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)
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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São Paulo, Brésil
- Instituto Dante Pazzanese
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A Coruña, Espagne
- Complejo Hospitalario Universitario A Coruña
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El Palmar, Espagne
- Hospital Universitario Virgen Arrixaca-Murcia
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Oviedo, Espagne
- Hospital Universitario Central Asturias-Oviedo
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Santiago de Compostela, Espagne
- Complejo Hospitalario Universitario Santiago de Compostela
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Catania, Italie
- Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
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Florence, Italie, 50134
- Azienda Ospedaliero Universitaria Careggi
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Milan, Italie
- San Raffaele Hospital
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Milan, Italie
- Cardiologico Monzino
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Skopje, Macédoine, l'ex-République yougoslave de, 1000
- PHE University Cardiology clinic
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Belgrade, Serbie
- Clinical Center of Serbia
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Belgrade, Serbie
- Clinical Hospital Center Zemun (CHC Zemun)
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Nis, Serbie
- Clinical center Nis (CCNIs)
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: 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)
Autres noms:
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Autres noms:
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Comparateur actif: 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)
Autres noms:
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Target Vessel Failure (TVF)
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Target lesion failure
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 6-mnths
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angiographic assessment of late loss at 6 months
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6-mnths
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Vladimir Borovicanin, MD, Terumo Europe
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- T120E4
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