Clinical trial NCT02828683: Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study
Official title: Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute ST Segment Elevation Myocardial Infarction
Keywords: DES
PCI
STEMI
Interventional Cardiology
Lead sponsor: Terumo Europe N.V.
Sponsor class: INDUSTRY
First posted: 2016-07-12
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Target Vessel Failure (TVF)
timeFrame: 12 months
Secondary outcomes:
measure: Target lesion failure
timeFrame: 1 month, 6 months, 12 months, 2 and 3 years
measure: Target vessel failure
timeFrame: 1 month, 6 months, 2 and 3 years
measure: Stent thrombosis
timeFrame: 1 month, 6 months, 12 months, 2 and 3 years
measure: Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
timeFrame: 1 month, 6 months, 12 months, 2 and 3 years
measure: Target lesion revascularization
timeFrame: 1 month, 6 months, 12 months, 2 and 3 years
measure: Bleeding
timeFrame: 1 month, 6 months, 12 months, 2 and 3 years
measure: Safety - revascularization, stroke, definite stent thrombosis or major bleeding
timeFrame: 1 month
measure: In-Stent late loss
timeFrame: 6-mnths
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese
city: Catania
country: Italy
facility: Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
city: Florence
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi
city: Milan
country: Italy
facility: Cardiologico Monzino
city: Milan
country: Italy
facility: San Raffaele Hospital
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: PHE University Cardiology clinic
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Zemun (CHC Zemun)
city: Nis
country: Serbia
facility: Clinical center Nis (CCNIs)
city: A Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña
city: El Palmar
country: Spain
facility: Hospital Universitario Virgen Arrixaca-Murcia
city: Oviedo
country: Spain
facility: Hospital Universitario Central Asturias-Oviedo
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago de Compostela
Study officials:
affiliation: Terumo Europe
name: Vladimir Borovicanin, MD
role: STUDY_DIRECTOR
References: