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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03023020




Registration number
NCT03023020
Ethics application status
Date submitted
29/12/2016
Date registered
18/01/2017

Titles & IDs
Public title
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Scientific title
Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen
Secondary ID [1] 0 0
ECRI-009
Universal Trial Number (UTN)
Trial acronym
MASTER DAPT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Bleeding Risk 0 0
Coronary Artery Disease 0 0
PCI 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Aspirin
Treatment: Drugs - P2Y12 inhibitor

Other: Abbreviated antiplatelet regimen - Dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and a single antiplatelet agent is continued until at least 11 months post randomization (i.e. 12 months post stent implantation).

In patients on oral anticoagulants, dual antiplatelet therapy is discontinued immediately after randomization (i.e. 1 month post stent implantation), and either Aspirin or Clopidogrel is continued until 5 months post randomization (i.e. 6 months post stent implantation). Oral anticoagulation is continued until at least 11 months post randomization (i.e. 12 months post stent implantation)

Other: Prolonged antiplatelet regimen - Aspirin is continued for at least 11 months post randomization (i.e. 12 months post stent implantation), the P2Y12 inhibitor being taken at the time of randomization is continued for at least 5 months and up to 11 months post randomization (i.e. 12 months post stent implantation).

In patients on oral anticoagulants, aspirin and Clopidogrel are continued for at least 2 months post randomization (i.e. 3 months post stent implantation) and up to 11 months post randomization (i.e. 12 months after stent implantation). Either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)


Treatment: Drugs: Aspirin
Dosing per current guidelines and local practice

Treatment: Drugs: P2Y12 inhibitor
Dosing per current guidelines and local practice
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Net adverse clinical endpoints (NACE) defined as a composite of all-cause death, myocardial infarction, stroke and bleeding events defined as BARC 3 or 5
Timepoint [1] 0 0
11 months
Primary outcome [2] 0 0
Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
Timepoint [2] 0 0
11 months
Primary outcome [3] 0 0
Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Timepoint [3] 0 0
11 months
Secondary outcome [1] 0 0
All cause death
Timepoint [1] 0 0
14 months
Secondary outcome [2] 0 0
Death from cardiovascular causes
Timepoint [2] 0 0
14 months
Secondary outcome [3] 0 0
Myocardial infarction
Timepoint [3] 0 0
14 months
Secondary outcome [4] 0 0
Stroke
Timepoint [4] 0 0
14 months
Secondary outcome [5] 0 0
Bleeding events
Timepoint [5] 0 0
14 months
Secondary outcome [6] 0 0
Definite or probable stent thrombosis
Timepoint [6] 0 0
14 months
Secondary outcome [7] 0 0
Any target vessel revascularization
Timepoint [7] 0 0
14 months
Secondary outcome [8] 0 0
Urgent target vessel revascularization
Timepoint [8] 0 0
14 months
Secondary outcome [9] 0 0
Urgent non-target vessel revascularization
Timepoint [9] 0 0
14 months
Secondary outcome [10] 0 0
Clinically indicated non-target vessel revascularization
Timepoint [10] 0 0
14 months
Secondary outcome [11] 0 0
Transfusion rates both in patients with and/or without clinically detected over bleeding
Timepoint [11] 0 0
14 months

Eligibility
Key inclusion criteria
After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met.

1. At least one among the HBR criteria (as defined below) is met.
2. All lesions are successfully treated with Ultimaster stent in the context of routine clinical care, i.e. post-procedural angiographic diameter stenosis <20% by visual estimation
3. Free from any flow-limiting angiographic complications (i.e. significant untreated dissection or major side-branch occlusion), which require prolonged DAPT duration based on operator's opinion.
4. All stages of PCI are complete (if any) and no further PCI is planned.

At randomization visit (one month after index PCI), the following criteria must be met:

1. Fulfilment of at least one HBR criterion (as defined below), or on the basis of post-PCI actionable (i.e. requiring medical attention) non-access site related bleeding episode
2. Uneventful 30-day clinical course, i.e. free from spontaneous MI, symptomatic restenosis, stent thrombosis, stroke and any revascularization (coronary and non-coronary) requiring prolonged DAPT
3. If not on OAC,

1. Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
2. Patient with one type of P2Y12 inhibitor for at least 7 days (i.e. no switching between oral P2Y12 inhibitors has occurred in the previous 7 days)
4. If on OAC

1. Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
2. Patient is on clopidogrel for at least 7 days

Definition of HBR

Post-PCI patients are at HBR if at least one of the following criteria applies:

* Clinical indication for treatment with oral anticoagulants (OAC) for at least 12 months
* Recent (<12 months) non-access site bleeding episode(s), which required medical attention (i.e. actionable bleeding).
* Previous bleeding episode(s) which required hospitalization if the underlying cause has not been definitively treated (i.e. surgical removal of the bleeding source)
* Age equal or greater than 75 years
* Systemic conditions associated with an increased bleeding risk (e.g. haematological disorders, including a history of or current thrombocytopaenia defined as a platelet count <100,000/mm3 (<100 x 109/L), or any known coagulation disorder associated with increased bleeding risk.
* Documented anaemia defined as repeated haemoglobin levels <11 g/dl or transfusion within 4 weeks before randomization.
* Need for chronic treatment with steroids or non-steroidal anti-inflammatory drugs
* Diagnosed malignancy (other than skin) considered at high bleeding risk including gastro-intestinal, genito-urethral/renal and pulmonary.
* Stroke at any time or TIA in the previous 6 months
* PRECISE DAPT score of 25 or greater
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treated with stents other than Ultimaster stent within 6 months prior to index procedure
2. Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
3. Treated with a bioresorbable scaffold at any time prior to index procedure
4. Cannot provide written informed consent
5. Under judicial protection, tutorship or curatorship
6. Unable to understand and follow study-related instructions or unable to comply with study protocol
7. Active bleeding requiring medical attention (BARC=2) on randomization visit
8. Life expectancy less than one year
9. Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
10. Any planned and anticipated PCI
11. Participation in another trial
12. Pregnant or breast feeding women

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/04/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
30/04/2021
Sample size
Target
Accrual to date
Final
4579
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 0 0
St Vincents Hospital Melbourne - Melbourne
Recruitment hospital [3] 0 0
Research Center Perth - Perth
Recruitment hospital [4] 0 0
Research Center Sydney - Sydney
Recruitment hospital [5] 0 0
Wollongong Research Center - Wollongong
Recruitment postcode(s) [1] 0 0
- Chermside
Recruitment postcode(s) [2] 0 0
- Melbourne
Recruitment postcode(s) [3] 0 0
- Perth
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment postcode(s) [5] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Bahrain
State/province [3] 0 0
Manama
Country [4] 0 0
Bangladesh
State/province [4] 0 0
Dhaka
Country [5] 0 0
Belgium
State/province [5] 0 0
Aalst
Country [6] 0 0
Belgium
State/province [6] 0 0
Bonheiden
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Charleroi
Country [9] 0 0
Belgium
State/province [9] 0 0
Hasselt
Country [10] 0 0
Belgium
State/province [10] 0 0
Liège
Country [11] 0 0
Bulgaria
State/province [11] 0 0
Plovdiv
Country [12] 0 0
Bulgaria
State/province [12] 0 0
Sofia
Country [13] 0 0
Czechia
State/province [13] 0 0
Brno
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha
Country [15] 0 0
Denmark
State/province [15] 0 0
Roskilde
Country [16] 0 0
Estonia
State/province [16] 0 0
Tallinn
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France
State/province [17] 0 0
Annecy
Country [18] 0 0
France
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Caen
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France
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Créteil
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France
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Dijon
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France
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Marseille
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France
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Massy
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France
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Metz
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France
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Montauban
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France
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Montpellier
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France
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Nantes
Country [27] 0 0
France
State/province [27] 0 0
Nîmes
Country [28] 0 0
France
State/province [28] 0 0
Paris
Country [29] 0 0
France
State/province [29] 0 0
Rouen
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France
State/province [30] 0 0
Saint-Denis
Country [31] 0 0
Germany
State/province [31] 0 0
Homburg
Country [32] 0 0
Germany
State/province [32] 0 0
Landshut
Country [33] 0 0
Hungary
State/province [33] 0 0
Budapest
Country [34] 0 0
Hungary
State/province [34] 0 0
Szeged
Country [35] 0 0
India
State/province [35] 0 0
Chennai
Country [36] 0 0
India
State/province [36] 0 0
Coimbatore
Country [37] 0 0
India
State/province [37] 0 0
Surat
Country [38] 0 0
Israel
State/province [38] 0 0
Haifa
Country [39] 0 0
Israel
State/province [39] 0 0
Jerusalem
Country [40] 0 0
Israel
State/province [40] 0 0
Petah tikva
Country [41] 0 0
Israel
State/province [41] 0 0
Safed
Country [42] 0 0
Italy
State/province [42] 0 0
Andria
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Italy
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Cagliari
Country [44] 0 0
Italy
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Caserta
Country [45] 0 0
Italy
State/province [45] 0 0
Catania
Country [46] 0 0
Italy
State/province [46] 0 0
Messina
Country [47] 0 0
Italy
State/province [47] 0 0
Milan
Country [48] 0 0
Italy
State/province [48] 0 0
Roma
Country [49] 0 0
Italy
State/province [49] 0 0
Rome
Country [50] 0 0
Italy
State/province [50] 0 0
Rozzano
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Italy
State/province [51] 0 0
Treviglio
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Italy
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Vimercate
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Japan
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Fukuoka
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Japan
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Gifu
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Japan
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Ichinomiya
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Japan
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Kawasaki
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Japan
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Nagakute
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Japan
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Nagoya
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Japan
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Osaka
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Japan
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Tokyo
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Japan
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Toyoake
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Korea, Republic of
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Seoul
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Netherlands
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's Hertogenbosch
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Netherlands
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Arnhem
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Breda
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Dordrecht
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Eindhoven
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Emmen
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Enschede
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Nieuwegein
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Rotterdam
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Netherlands
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Terneuzen
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Netherlands
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The Hague
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North Macedonia
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Skopje
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Lubin
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Poland
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Poznan
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Poland
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Wroclaw
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Saudi Arabia
State/province [80] 0 0
Jeddah
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Saudi Arabia
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Riyadh
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Serbia
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Belgrade
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Serbia
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Sremska Kamenica
Country [84] 0 0
Singapore
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Singapore
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Slovenia
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Ljubljana
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Spain
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Alicante
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Spain
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Barcelona
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Spain
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El Palmar
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Spain
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Huelva
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Spain
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Madrid
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Spain
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Santander
Country [92] 0 0
Spain
State/province [92] 0 0
Vigo
Country [93] 0 0
Sweden
State/province [93] 0 0
Gävle
Country [94] 0 0
Sweden
State/province [94] 0 0
Örebro
Country [95] 0 0
Switzerland
State/province [95] 0 0
Bern
Country [96] 0 0
Switzerland
State/province [96] 0 0
Fribourg
Country [97] 0 0
Switzerland
State/province [97] 0 0
Geneva
Country [98] 0 0
Switzerland
State/province [98] 0 0
Liestal
Country [99] 0 0
Switzerland
State/province [99] 0 0
Lugano
Country [100] 0 0
Switzerland
State/province [100] 0 0
Zürich
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Blackburn
Country [102] 0 0
United Kingdom
State/province [102] 0 0
Bournemouth
Country [103] 0 0
United Kingdom
State/province [103] 0 0
Brighton
Country [104] 0 0
United Kingdom
State/province [104] 0 0
Bristol
Country [105] 0 0
United Kingdom
State/province [105] 0 0
Derry
Country [106] 0 0
United Kingdom
State/province [106] 0 0
London
Country [107] 0 0
United Kingdom
State/province [107] 0 0
Manchester
Country [108] 0 0
United Kingdom
State/province [108] 0 0
Newcastle Upon Tyne
Country [109] 0 0
United Kingdom
State/province [109] 0 0
Stevenage
Country [110] 0 0
United Kingdom
State/province [110] 0 0
Stoke-on-Trent
Country [111] 0 0
United Kingdom
State/province [111] 0 0
Wolverhampton
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Worcester
Country [113] 0 0
Vietnam
State/province [113] 0 0
Hanoi

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
ECRI bv
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Cardialysis B.V.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
European Cardiovascular Research Center
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
University of Bern
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Commercial sector/industry
Name [4] 0 0
Terumo Medical Corporation
Address [4] 0 0
Country [4] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
M. Valgimigli, Prof.
Address 0 0
Cardiocentro Ticino Foundation, Lugano, Switzerland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03023020