Acute ST Segment Elevation Myocardial InfarctionMASTERNCT02828683
Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in STEMI Patients - MASTER Study
A study testing PCI in patients with ST-elevation myocardial infarction in people with Acute ST Segment Elevation Myocardial Infarction, run by Terumo Europe N.V. at 13 sites in 5 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute ST Segment Elevation Myocardial Infarction
- What is being tested?
- PCI in patients with ST-elevation myocardial infarction
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 13 sitesin 5 countries
- Study dates
- Jul 2013to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
13 sites in 5 countries.
13 sites in 5 countries
Italy4 sites
Azienda Ospedaliero Universitaria, Policlinico "Vittorio Emanuele" - Ospedale Ferrarotto
Catania
Azienda Ospedaliero Universitaria Careggi
Florence, 50134
Cardiologico Monzino
Milan
San Raffaele Hospital
Milan
Spain4 sites
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital Universitario Virgen Arrixaca-Murcia
El Palmar
Hospital Universitario Central Asturias-Oviedo
Oviedo
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela
Serbia3 sites
Clinical Center of Serbia
Belgrade
Clinical Hospital Center Zemun (CHC Zemun)
Belgrade
Clinical center Nis (CCNIs)
Niš
About this 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
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.
Read the 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)
- Being tested
- PCI in patients with ST-elevation myocardial infarction
- Keywords
- DES, PCI, STEMI, Interventional Cardiology
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCI in patients with ST-elevation myocardial infarctionDevice
Also called Primary PCI
Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
PCI in patients with ST-elevation myocardial infarctionDevice
Also called Primary PCI
Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
| Study group | Role | What they receive |
|---|---|---|
| Ultimaster, Drug Eluting Stent | Experimental | Primary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster Receives: Device: PCI in patients with ST-elevation myocardial infarction |
| Kaname, Bare metal stent | Active comparator | Primary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname Receives: Device: PCI in patients with ST-elevation myocardial infarction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Vessel Failure (TVF)
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
Measured: 12 months
Secondary outcomes (8)
Target lesion failure
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
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
Composite of cardiac death, target vessel myocardial infarction, target vessel revascularization
Measured: 1 month, 6 months, 2 and 3 years
Stent thrombosis
Thrombosis in study stents
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Patient oriented endpoint Composite of any death, any myocardial infarction, any coronary revascularization
Composite of any death, any myocardial infarction, any coronary revascularization
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Target lesion revascularization
revascularization of treated lesion
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Bleeding
Access or non access site bleeding
Measured: 1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
revascularization, stroke, definite stent thrombosis or major bleeding at 1 month
Measured: 1 month
In-Stent late loss
angiographic assessment of late loss at 6 months
Measured: 6-mnths
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startJul 2013
- Primary completionJul 2016
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute ST Segment Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terumo Europe N.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Vladimir Borovicanin, MD, Study director, Terumo Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02828683
- Sponsor's protocol ID
- T120E4
- Acronym
- MASTER
- Status last verified
- Jul 2018
- First submitted
- 16 May 2013
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of TCD-10023 (Ultimaster) Drug-eluting Stent in Management of Patients With Acute ST-Elevation Myocardial InfaRction - MASTER Study
- ClinicalTrials.gov ID
- NCT02828683
- Acronym / sponsor ID
- MASTER / T120E4
- Keywords
- DES, PCI, STEMI, Interventional Cardiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Terumo Europe N.V.Industry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultimaster, Drug Eluting Stent | Experimental | Device: PCI in patients with ST-elevation myocardial infarctionPrimary PCI in patients with ST segment elevation myocardial infarction with a new Drug Eluting Stent, Ultimaster |
| Kaname, Bare metal stent | Active comparator | Device: PCI in patients with ST-elevation myocardial infarctionPrimary PCI in patients with ST segment elevation myocardial infarction with a Bare Metal Stent - Kaname |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCI in patients with ST-elevation myocardial infarctionAlso: Primary PCIPercutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI) | Device | Ultimaster, Drug Eluting Stent |
| PCI in patients with ST-elevation myocardial infarctionAlso: Primary PCIPercutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction | Device | Kaname, Bare metal stent |
Primary outcome
Target Vessel Failure (TVF)
Time frame: 12 months
Composite endpoint of cardiac death, target vessel myocardial infarctio and target vessel revascularization
8 secondary outcomes
Target lesion failure
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Target vessel failure
Time frame: 1 month, 6 months, 2 and 3 years
Stent thrombosis
Time frame: 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
Target lesion revascularization
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Bleeding
Time frame: 1 month, 6 months, 12 months, 2 and 3 years
Safety - revascularization, stroke, definite stent thrombosis or major bleeding
Time frame: 1 month
In-Stent late loss
Time frame: 6-mnths
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vladimir Borovicanin, MD study director
Terumo Europe
13 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in patients with ST-elevation myocardial infarction in people with Acute ST Segment Elevation Myocardial Infarction, run by Terumo Europe N.V. at 13 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Italy, Spain, Serbia, Brazil, North Macedonia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Vessel Failure (TVF) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.