Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study (MASTER)

July 3, 2018 updated by: 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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)

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Instituto Dante Pazzanese
  • Italy
      • Catania, Italy
        • Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
      • Florence, Italy, 50134
        • Azienda Ospedaliero Universitaria Careggi
      • Milan, Italy
        • San Raffaele Hospital
      • Milan, Italy
        • Cardiologico Monzino
  • Macedonia, The Former Yugoslav Republic of
      • Skopje, Macedonia, The Former Yugoslav Republic of, 1000
        • PHE University Cardiology clinic
  • Serbia
      • Belgrade, Serbia
        • Clinical Center of Serbia
      • Belgrade, Serbia
        • Clinical Hospital Center Zemun (CHC Zemun)
      • Nis, Serbia
        • Clinical center Nis (CCNIs)
  • Spain
      • A Coruña, Spain
        • Complejo Hospitalario Universitario A Coruna
      • El Palmar, Spain
        • Hospital Universitario Virgen Arrixaca-Murcia
      • Oviedo, Spain
        • Hospital Universitario Central Asturias-Oviedo
      • Santiago de Compostela, Spain
        • Complejo Hospitalario Universitario Santiago de Compostela

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultimaster, Drug Eluting Stent
Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster
Device: PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Other Names:
  • Primary PCI
Device: PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Other Names:
  • Primary PCI
Active Comparator: Kaname, Bare metal stent
Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname
Device: PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
Other Names:
  • Primary PCI
Device: PCI in patients with ST-elevation myocardial infarction
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
Other Names:
  • Primary PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target Vessel Failure (TVF)
Time Frame: 12 months
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Target lesion failure
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
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
1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
Time Frame: 1 month, 6 months, 2 and 3 years
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
1 month, 6 months, 2 and 3 years
Stent thrombosis
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Thrombosis in study stents
1 month, 6 months, 12 months, 2 and 3 years
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Composite of any death, any myocardial infarction, any coronary revascularization
1 month, 6 months, 12 months, 2 and 3 years
Target lesion revascularization
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
revascularization of treated lesion
1 month, 6 months, 12 months, 2 and 3 years
Bleeding
Time Frame: 1 month, 6 months, 12 months, 2 and 3 years
Access or non access site bleeding
1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
Time Frame: 1 month
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
1 month
In-Stent late loss
Time Frame: 6-mnths
angiographic assessment of late loss at 6 months
6-mnths

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Terumo Europe N.V.

Investigators

  • Study Director: Vladimir Borovicanin, MD, Terumo Europe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

May 16, 2013

First Submitted That Met QC Criteria

July 11, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 3, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T120E4

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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