Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen (MASTER DAPT)

August 19, 2021 updated by: ECRI bv

The study compares two lengths of medication therapy (a shortened versus a prolonged dual antiplatelet therapy) in order to prevent thrombus (blood cloth) formation after the successfully treatment for coronary heart disease with a drug covered stent (metallic tube).

This comparison will be done in patients who, compared to the average patient, are more likely to suffer from complications on antiplatelet therapy (bleeding). Both durations are within the current medical recommendations. The aim of this study is to help improve further standard antiplatelet duration guidelines.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study objective is to determine in a high bleeding risk patient population undergoing PCI under standardized treatment (within current guidelines and instructions for use and including the bioresorbable polymer coated Ultimaster sirolimus-eluting stent), whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of NACE within 12 months, whether abbreviated DAPT is non-inferior to prolonged DAPT regimen in terms of MACCE within 12 months and whether abbreviated DAPT is superior to prolonged DAPT regimen in terms of MCB within 12 months.

There are two treatment strategies:

  • abbreviated dual anti-platelet therapy: dual antiplatelet therapy is discontinued 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 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) OR
  • prolonged dual anti-platelet therapy: 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). Therefore either aspirin or Clopidogrel is continued up to 11 months post randomization (i.e. 12 months post stent implantation)

The study design is an investigator-initiated, randomized, multi-center, clinical trial to be conducted in approximately 100 interventional cardiology centers in across the globe excluding USA. The study includes 2 x 2150 patients (i.e. 4300 patients) Randomization will occur at one month after the PCI procedure. The expected duration of participation for each patient is 14 months.

Study Type

Interventional

Enrollment (Actual)

4579

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

  • Argentina
      • Buenos Aires, Argentina
        • Buenos Aires Research center
      • Buenos Aires, Argentina
        • Interventional Cardiology Sanatorio
  • Australia
      • Chermside, Australia
        • The Prince Charles Hospital
      • Melbourne, Australia
        • St Vincents Hospital Melbourne
      • Perth, Australia
        • Research Center Perth
      • Sydney, Australia
        • Research Center Sydney
      • Wollongong, Australia
        • Wollongong Research Center
  • Austria
      • Wien, Austria
        • Research Center , 043-02
      • Wien, Austria
        • Research Center, 043-01
  • Bahrain
      • Manama, Bahrain
        • Research Centre Manama
  • Bangladesh
      • Dhaka, Bangladesh
        • Dhaka Research Center
  • Belgium
      • Aalst, Belgium
        • Research Center Aalst
      • Bonheiden, Belgium
        • Research Center Bonheiden
      • Bruxelles, Belgium
        • CHU st.Pierre
      • Charleroi, Belgium
        • Research Centre Charleroi
      • Hasselt, Belgium
        • Research Center Hasselt
      • Liège, Belgium
        • Research Centre Liège
  • Bulgaria
      • Plovdiv, Bulgaria
        • MHAT Sveta Karidad Plovdiv
      • Sofia, Bulgaria
        • Sofia Resaerch Center, 359-02
      • Sofia, Bulgaria
        • Sofia Research Center, 359-01
      • Sofia, Bulgaria
        • Sofia Research Center, 359-03
  • Czechia
      • Brno, Czechia
        • Research Center Brno
      • Praha, Czechia
        • Research Center Phraha
  • Denmark
      • Roskilde, Denmark
        • Research Center Roskilde
  • Estonia
      • Tallinn, Estonia
        • Research Center Tallinn
  • France
      • Annecy, France
        • Research Center Annecy
      • Caen, France
        • Hospital Prive Saint Martin
      • Caen, France
        • Research Centre Caen
      • Créteil, France
        • Research Centre Créteil
      • Dijon, France
        • Research Center Dijon
      • Marseille, France
        • Hopital de la Timone
      • Massy, France
        • Research Center Massy
      • Metz, France
        • Hospital de Mercy
      • Montauban, France
        • Research Center Montauban
      • Montpellier, France
        • Research Centre Montpellier
      • Nantes, France
        • Research Center Nantes
      • Nîmes, France
        • CHU Nimes
      • Paris, France
        • Research Center Paris, 033-05
      • Paris, France
        • Research Center Paris, 033-06
      • Rouen, France
        • Research Centre Rouen
      • Saint-Denis, France
        • Research Center Saint-Denis
  • Germany
      • Homburg, Germany
        • Saarland University
      • Landshut, Germany
        • Cardiology Clinic
  • Hungary
      • Budapest, Hungary
        • Research Centre Budapest
      • Szeged, Hungary
        • Research Center Szeged
  • India
      • Chennai, India
        • Research Center Chennai, 091-01
      • Chennai, India
        • Research Center Chennai, 091-05
      • Coimbatore, India
        • Research Center Coimbatore
      • Sūrat, India
        • Research Center Surat
  • Israel
      • Haifa, Israel
        • Research Center Haifa
      • Jerusalem, Israel
        • Research Center Jerusalem
      • Petah tikva, Israel
        • Rabin MC
      • Safed, Israel
        • Research Center Safed
  • Italy
      • Andria, Italy
        • Ospedale Lorenzo Bonomo
      • Cagliari, Italy
        • Azienda Ospedaliera Brotzu
      • Caserta, Italy
        • Second university of Naples Monaldi Hospital
      • Catania, Italy
        • Research Center Catania
      • Messina, Italy
        • AOU Policlinico Gaetano Martino
      • Milan, Italy
        • San Donato Hospital
      • Milan, Italy
        • Niguarda
      • Milan, Italy
        • Research Center Milan, 039-01
      • Milan, Italy
        • Research Center Milan, 039-04
      • Milan, Italy
        • Research Center Milan, 039-11
      • Roma, Italy
        • Ospedale Sandro Pertini
      • Rome, Italy
        • Policlinico Casilino
      • Rome, Italy
        • Policlinico Umberto I
      • Rozzano, Italy
        • Research Center Rozzano
      • Treviglio, Italy
        • Clinic Cardiology
      • Vimercate, Italy
        • Research Center Vimercate
  • Japan
      • Fukuoka, Japan
        • Kokura Memorial Hospital
      • Gifu, Japan
        • Research Center Gifu
      • Ichinomiya, Japan
        • Ichinomiya Municipal Hospital
      • Kawasaki, Japan
        • St.Marianna University School of Medicine
      • Nagakute, Japan
        • Aichi Medical University Hospital
      • Nagoya, Japan
        • Nagoya University Hospital
      • Nagoya, Japan
        • Japan Red Cross Nagoya Daiichi Hospital (1st)
      • Nagoya, Japan
        • Japan Red Cross Nagoya Daini Hospital (2nd)
      • Osaka, Japan
        • Osaka Police Hospital
      • Tokyo, Japan
        • St.Luke's International Hospital
      • Toyoake, Japan
        • Research Center Toyoake
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Center Seoul
  • Netherlands
      • 's Hertogenbosch, Netherlands
        • Research Center Den Bosch
      • Arnhem, Netherlands
        • Research Centre Arnhem
      • Breda, Netherlands
        • Research Center Breda
      • Dordrecht, Netherlands
        • Research Centre Dordrecht
      • Eindhoven, Netherlands
        • Research Centre Eindhoven
      • Emmen, Netherlands
        • Research Center Emmen
      • Enschede, Netherlands
        • Research Centre Enschede
      • Nieuwegein, Netherlands
        • Antonius Ziekenhuis
      • Rotterdam, Netherlands
        • Research Center Rotterdam
      • Terneuzen, Netherlands
        • Research Centre Terneuzen
      • The Hague, Netherlands
        • Haga hospital
  • North Macedonia
      • Skopje, North Macedonia
        • Research Center Skopje
  • Poland
      • Krakow, Poland
        • University Hospital Krakow
      • Kraków, Poland
        • Research Center Krakow
      • Lubin, Poland
        • Miedziowe Centrum Zdrowia SA
      • Poznań, Poland
        • Research Center Poznan
      • Wrocław, Poland
        • Research Centre Wroclaw
  • Saudi Arabia
      • Jeddah, Saudi Arabia
        • Research Center Jeddah
      • Riyadh, Saudi Arabia
        • Research Center Riyadh
  • Serbia
      • Belgrade, Serbia
        • Researcg Center Belgrade, 381-02
      • Belgrade, Serbia
        • Research Center of Serbia, 381-01
      • Sremska Kamenica, Serbia
        • Research Center Sremska Kamenica
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
      • Singapore, Singapore
        • Singapore Research Center
  • Slovenia
      • Ljubljana, Slovenia
        • Ljubljana Research Center
  • Spain
      • Alicante, Spain
        • Research Center Alicante
      • Barcelona, Spain
        • Research Center Barcelona, 034-07
      • Barcelona, Spain
        • Research Center Barcelona, 034-09
      • El Palmar, Spain
        • Universitario Virgen de la Arrixaca
      • Huelva, Spain
        • Research Center Huelva
      • Madrid, Spain
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain
        • Research Center Madrid, 034-06
      • Madrid, Spain
        • Research Center Madrid, 034-10
      • Santander, Spain
        • Hospital Universitario Valdecilla
      • Vigo, Spain
        • Research Center Vigo
  • Sweden
      • Gävle, Sweden
        • Research Center Gavle
      • Örebro, Sweden
        • Research Center Orebro
  • Switzerland
      • Bern, Switzerland
        • Lindenhofspital
      • Bern, Switzerland
        • Research Centre Bern
      • Fribourg, Switzerland
        • Research Centre Fribourg
      • Geneva, Switzerland
        • University Hospital Geneva
      • Liestal, Switzerland
        • Research Centre Liestal
      • Lugano, Switzerland
        • Research Centre Lugano
      • Zürich, Switzerland
        • Research Centre Zürich
  • United Kingdom
      • Blackburn, United Kingdom
        • Research Center Blackburn
      • Bournemouth, United Kingdom
        • Research Center Bournemouth
      • Brighton, United Kingdom
        • Research Centre Brighton
      • Bristol, United Kingdom
        • Bristol Heart Institute
      • Derry, United Kingdom
        • Altnagelvin Hospital
      • London, United Kingdom
        • St George's Hospital
      • Manchester, United Kingdom
        • Manchester Research Center
      • Newcastle Upon Tyne, United Kingdom
        • Research Center Newcastle
      • Stevenage, United Kingdom
        • Research Center Stevenage
      • Stoke-on-Trent, United Kingdom
        • Research Centre Stoke-on-Trent
      • Wolverhampton, United Kingdom
        • Research Centre Wolverhampton
      • Worcester, United Kingdom
        • Research Centre Worcester
  • Vietnam
      • Hanoi, Vietnam
        • Vietnam National Heart Institute

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:

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

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 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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Aspirin
Dosing per current guidelines and local practice
Other Names:
  • antiplatelet agent
Drug: P2Y12 inhibitor
Dosing per current guidelines and local practice
Other Names:
  • antiplatelet agent
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)
Drug: Aspirin
Dosing per current guidelines and local practice
Other Names:
  • antiplatelet agent
Drug: P2Y12 inhibitor
Dosing per current guidelines and local practice
Other Names:
  • antiplatelet agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 11 months
11 months
Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke
Time Frame: 11 months
11 months
Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events
Time Frame: 11 months
11 months

Secondary Outcome Measures

Outcome Measure
Time Frame
All cause death
Time Frame: 14 months
14 months
Death from cardiovascular causes
Time Frame: 14 months
14 months
Myocardial infarction
Time Frame: 14 months
14 months
Stroke
Time Frame: 14 months
14 months
Bleeding events
Time Frame: 14 months
14 months
Definite or probable stent thrombosis
Time Frame: 14 months
14 months
Any target vessel revascularization
Time Frame: 14 months
14 months
Urgent target vessel revascularization
Time Frame: 14 months
14 months
Urgent non-target vessel revascularization
Time Frame: 14 months
14 months
Clinically indicated non-target vessel revascularization
Time Frame: 14 months
14 months
Transfusion rates both in patients with and/or without clinically detected over bleeding
Time Frame: 14 months
14 months

Collaborators and Investigators

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

Sponsor

ECRI bv

Collaborators

University of Bern
European Cardiovascular Research Center
Terumo Medical Corporation
Cardialysis B.V.

Investigators

  • Principal Investigator: M. Valgimigli, Prof., Cardiocentro Ticino Foundation, Lugano, Switzerland
  • Principal Investigator: P. Smits, Dr., Maasstad Ziekenhuis Rotterdam, The Netherlands
  • Study Director: E. Spitzer, Dr., ECRI bv

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

April 4, 2017

Primary Completion (Actual)

April 30, 2021

Study Completion (Actual)

April 30, 2021

Study Registration Dates

First Submitted

December 29, 2016

First Submitted That Met QC Criteria

January 13, 2017

First Posted (Estimate)

January 18, 2017

Study Record Updates

Last Update Posted (Actual)

August 20, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ECRI-009

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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