AzTrials
AzTrials

High Bleeding RiskMASTER DAPTNCT03023020

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

A study testing Aspirin and P2Y12 inhibitor in people with High Bleeding Risk and Coronary Artery Disease, run by ECRI bv at 138 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High Bleeding Risk, Coronary Artery Disease, PCI
What is being tested?
Aspirin and P2Y12 inhibitor
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,579 participants
Where
138 sitesin 30 countries
Study dates
4 Apr 2017to 30 Apr 2021
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

  • After index PCI, patients aged 18 years or more are eligible for inclusion into the study if the following criteria are met.
  • At least one among the HBR criteria (as defined below) is met.
  • 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
  • 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.
  • 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:
Show all 26Show fewer
  • 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
  • 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
  • If not on OAC,
  • Patient is on a DAPT regimen of aspirin and a P2Y12 inhibitor
  • 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)
  • If on OAC
  • Patient is on the same type of OAC (e.g. Vitamin K antagonist or NOAC) for at least 7 days
  • 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

Who cannot join

  • Treated with stents other than Ultimaster stent within 6 months prior to index procedure
  • Treated for in-stent restenosis or stent thrombosis at index PCI or within 6 months before
  • Treated with a bioresorbable scaffold at any time prior to index procedure
  • Cannot provide written informed consent
  • Under judicial protection, tutorship or curatorship
  • Unable to understand and follow study-related instructions or unable to comply with study protocol
Show all 12Show fewer
  • Active bleeding requiring medical attention (BARC≥2) on randomization visit
  • Life expectancy less than one year
  • Known hypersensitivity or allergy for aspirin, clopidogrel, ticagrelor, prasugrel, cobalt chromium or sirolimus
  • Any planned and anticipated PCI
  • Participation in another trial
  • Pregnant or breast feeding women

Trial locations and contacts

138 sites in 30 countries.

138 sites in 30 countries

France16 sites

  • Research Center Annecy

    Annecy

  • Hospital Prive Saint Martin

    Caen

  • Research Centre Caen

    Caen

  • Research Centre Créteil

    Créteil

  • Research Center Dijon

    Dijon

  • Hopital de la Timone

    Marseille

  • Research Center Massy

    Massy

  • Hospital de Mercy

    Metz

  • Research Center Montauban

    Montauban

  • Research Centre Montpellier

    Montpellier

  • Research Center Nantes

    Nantes

  • CHU Nimes

    Nîmes

  • Research Center Paris, 033-05

    Paris

  • Research Center Paris, 033-06

    Paris

  • Research Centre Rouen

    Rouen

  • Research Center Saint-Denis

    Saint-Denis

Other trials in France

Italy16 sites

  • Ospedale Lorenzo Bonomo

    Andria

  • Azienda Ospedaliera Brotzu

    Cagliari

  • Second university of Naples Monaldi Hospital

    Caserta

  • Research Center Catania

    Catania

  • AOU Policlinico Gaetano Martino

    Messina

  • Niguarda

    Milan

  • Research Center Milan, 039-01

    Milan

  • Research Center Milan, 039-04

    Milan

  • Research Center Milan, 039-11

    Milan

  • San Donato Hospital

    Milan

  • Ospedale Sandro Pertini

    Roma

  • Policlinico Casilino

    Rome

  • Policlinico Umberto I

    Rome

  • Research Center Rozzano

    Rozzano

  • Clinic Cardiology

    Treviglio

  • Research Center Vimercate

    Vimercate

Other trials in Italy

United Kingdom12 sites

  • Research Center Blackburn

    Blackburn

  • Research Center Bournemouth

    Bournemouth

  • Research Centre Brighton

    Brighton

  • Bristol Heart Institute

    Bristol

  • St George's Hospital

    London

  • Altnagelvin Hospital

    Londonderry

  • Manchester Research Center

    Manchester

  • Research Center Newcastle

    Newcastle upon Tyne

  • Research Center Stevenage

    Stevenage

  • Research Centre Stoke-on-Trent

    Stoke-on-Trent

  • Research Centre Wolverhampton

    Wolverhampton

  • Research Centre Worcester

    Worcester

Other trials in United Kingdom

Japan11 sites

  • Kokura Memorial Hospital

    Fukuoka

  • Research Center Gifu

    Gifu

  • Ichinomiya Municipal Hospital

    Ichinomiya

  • St.Marianna University School of Medicine

    Kawasaki

  • Aichi Medical University Hospital

    Nagakute

  • Japan Red Cross Nagoya Daiichi Hospital (1st)

    Nagoya

  • Japan Red Cross Nagoya Daini Hospital (2nd)

    Nagoya

  • Nagoya University Hospital

    Nagoya

  • Osaka police Hospital

    Osaka

  • St.Luke's International Hospital

    Tokyo

  • Research Center Toyoake

    Toyoake

Other trials in Japan

Netherlands11 sites

  • Research Center Den Bosch

    's-Hertogenbosch

  • Research Centre Arnhem

    Arnhem

  • Research Center Breda

    Breda

  • Research Centre Dordrecht

    Dordrecht

  • Research Centre Eindhoven

    Eindhoven

  • Research Center Emmen

    Emmen

  • Research Centre Enschede

    Enschede

  • Antonius ziekenhuis

    Nieuwegein

  • Research Center Rotterdam

    Rotterdam

  • Research Centre Terneuzen

    Terneuzen

  • Haga Hospital

    The Hague

Other trials in Netherlands

Spain10 sites

  • Research Center Alicante

    Alicante

  • Research Center Barcelona, 034-07

    Barcelona

  • Research Center Barcelona, 034-09

    Barcelona

  • Universitario Virgen de la Arrixaca

    El Palmar

  • Research Center Huelva

    Huelva

  • Hospital Universitario Puerta de hierro

    Madrid

  • Research Center Madrid, 034-06

    Madrid

  • Research Center Madrid, 034-10

    Madrid

  • Hospital Universitario Valdecilla

    Santander

  • Research Center Vigo

    Vigo

Other trials in Spain

Switzerland7 sites

  • Lindenhofspital

    Bern

  • Research Centre Bern

    Bern

  • Research Centre Fribourg

    Fribourg

  • University Hospital Geneva

    Geneva

  • Research Centre Liestal

    Liestal

  • Research Centre Lugano

    Lugano

  • Research Centre Zürich

    Zurich

Other trials in Switzerland

Belgium6 sites

  • Research Center Aalst

    Aalst

  • Research Center Bonheiden

    Bonheiden

  • CHU st.Pierre

    Brussels

  • Research Centre Charleroi

    Charleroi

  • Research Center Hasselt

    Hasselt

  • Research Centre Liège

    Liège

Other trials in Belgium

Australia5 sites

  • The Prince Charles Hospital

    Chermside

  • St Vincents Hospital Melbourne

    Melbourne

  • Research Center Perth

    Perth

  • Research Center Sydney

    Sydney

  • Wollongong Research Center

    Wollongong

Other trials in Australia

Poland5 sites

  • Research Center Krakow

    Krakow

  • University Hospital Krakow

    Krakow

  • Miedziowe Centrum Zdrowia SA

    Lubin

  • Research Center Poznan

    Poznan

  • Research Centre Wroclaw

    Wroclaw

Other trials in Poland

Bulgaria4 sites

  • MHAT Sveta Karidad Plovdiv

    Plovdiv

  • Sofia Resaerch Center, 359-02

    Sofia

  • Sofia Research Center, 359-01

    Sofia

  • Sofia Research Center, 359-03

    Sofia

Other trials in Bulgaria

India4 sites

  • Research Center Chennai, 091-01

    Chennai

  • Research Center Chennai, 091-05

    Chennai

  • Research Center Coimbatore

    Coimbatore

  • Research Center Surat

    Sūrat

Other trials in India

Israel4 sites

  • Research Center Haifa

    Haifa

  • Research Center Jerusalem

    Jerusalem

  • Rabin MC

    Petah Tikva

  • Research Center Safed

    Safed

Other trials in Israel

Serbia3 sites

  • Researcg Center Belgrade, 381-02

    Belgrade

  • Research Center of Serbia, 381-01

    Belgrade

  • Research Center Sremska Kamenica

    Kamenitz

Other trials in Serbia

Argentina2 sites

  • Buenos Aires Research center

    Buenos Aires

  • Interventional Cardiology Sanatorio

    Buenos Aires

Other trials in Argentina

Austria2 sites

  • Research Center , 043-02

    Vienna

  • Research Center, 043-01

    Vienna

Other trials in Austria

Czechia2 sites

  • Research Center Brno

    Brno

  • Research Center Phraha

    Prague

Other trials in Czechia

Germany2 sites

  • Saarland University

    Homburg

  • Cardiology Clinic

    Landshut

Other trials in Germany

Hungary2 sites

  • Research Centre Budapest

    Budapest

  • Research Center Szeged

    Szeged

Other trials in Hungary

Saudi Arabia2 sites

  • Research Center Jeddah

    Jeddah

  • Research Center Riyadh

    Riyadh

Other trials in Saudi Arabia

Singapore2 sites

  • Singapore Research Center

    Singapore

  • Tan Tock Seng Hospital

    Singapore

Other trials in Singapore

Sweden2 sites

  • Research Center Gavle

    Gävle

  • Research Center Orebro

    Örebro

Other trials in Sweden

Bahrain1 site

  • Research Centre Manama

    Manama

Other trials in Bahrain

Bangladesh1 site

  • Dhaka Research Center

    Dhaka

Other trials in Bangladesh

Denmark1 site

  • Research Center Roskilde

    Roskilde

Other trials in Denmark

Estonia1 site

  • Research Center Tallinn

    Tallinn

Other trials in Estonia

North Macedonia1 site

  • Research Center Skopje

    Skopje

Other trials in North Macedonia

Slovenia1 site

  • Ljubljana Research Center

    Ljubljana

Other trials in Slovenia

South Korea1 site

  • Research Center Seoul

    Seoul

Other trials in South Korea

Vietnam1 site

  • Vietnam National Heart Institute

    Hanoi

Other trials in Vietnam

About this study

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.

Read the 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.

Being tested
Aspirin, P2Y12 inhibitor
Keywords
Dual Antiplatelet Therapy
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AspirinDrug

    Also called antiplatelet agent

    Dosing per current guidelines and local practice

  • P2Y12 inhibitorDrug

    Also called antiplatelet agent

    Dosing per current guidelines and local practice

Study groups in NCT03023020
Study groupRoleWhat they receive
Abbreviated antiplatelet regimenOtherDual 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)
Receives: Drug: Aspirin; Drug: P2Y12 inhibitor
Prolonged antiplatelet regimenOtherAspirin 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)
Receives: Drug: Aspirin; Drug: P2Y12 inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 11 months

  2. Major adverse cardiac and cerebral events (MACCE) defined as a composite of all-cause death, myocardial infarction and stroke

    Measured: 11 months

  3. Major or clinically relevant non-major bleeding (MCB) defined as a composite of type 2, 3 and 5 BARC bleeding events

    Measured: 11 months

Secondary outcomes (11)

  1. All cause death

    Measured: 14 months

  2. Death from cardiovascular causes

    Measured: 14 months

  3. Myocardial infarction

    Measured: 14 months

  4. Stroke

    Measured: 14 months

  5. Bleeding events

    Measured: 14 months

  6. Definite or probable stent thrombosis

    Measured: 14 months

  7. Any target vessel revascularization

    Measured: 14 months

  8. Urgent target vessel revascularization

    Measured: 14 months

  9. Urgent non-target vessel revascularization

    Measured: 14 months

  10. Clinically indicated non-target vessel revascularization

    Measured: 14 months

  11. Transfusion rates both in patients with and/or without clinically detected over bleeding

    Measured: 14 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2017 (estimated)
  2. Study start4 Apr 2017
  3. Primary completion30 Apr 2021
  4. Study completion30 Apr 2021

Resources

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
None (open label)
Enrolment
4,579 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03023020
Sponsor's protocol ID
ECRI-009
Acronym
MASTER DAPT
Status last verified
Aug 2021
First submitted
29 Dec 2016
Last updated
20 Aug 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Authors/Task Force members; Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. No abstract available.

    PubMed 25173339

  • Roffi M, Patrono C, Collet JP, Mueller C, Valgimigli M, Andreotti F, Bax JJ, Borger MA, Brotons C, Chew DP, Gencer B, Hasenfuss G, Kjeldsen K, Lancellotti P, Landmesser U, Mehilli J, Mukherjee D, Storey RF, Windecker S; ESC Scientific Document Group. 2015 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: Task Force for the Management of Acute Coronary Syndromes in Patients Presenting without Persistent ST-Segment Elevation of the European Society of Cardiology (ESC). Eur Heart J. 2016 Jan 14;37(3):267-315. doi: 10.1093/eurheartj/ehv320. Epub 2015 Aug 29. No abstract available.

    PubMed 26320110

  • Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, Granger CB, Lange RA, Mack MJ, Mauri L, Mehran R, Mukherjee D, Newby LK, O'Gara PT, Sabatine MS, Smith PK, Smith SC, Jr. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation 2016

  • Chevalier B, Cao D, Smits PC, Brunel P, Frigoli E, Heg D, Higuchi Y, Kauer F, Landi A, Lopes RD, Mainar V, Mamas MA, Mateev H, McDonald J, McFadden EP, Mulassary A, Munir S, Polad J, Reimers B, Sardella G, Ungi I, von Birgerlen C, Weidinger F, Paradies V, Valgimigli M; MASTER DAPT Investigators. Abbreviated Dual Antiplatelet Therapy in Patients With High Bleeding Risk Undergoing PCI of Bifurcation Lesions: A Prespecified Substudy of the MASTER DAPT Trial. Circ Cardiovasc Interv. 2026 Jul 13:e016222. doi: 10.1161/CIRCINTERVENTIONS.125.016222. Online ahead of print.

    PubMed 42439019

  • Landi A, Mahfoud F, Frigoli E, Chalkou K, Heg D, Abhaichand RK, Abhyankar AD, Barbato E, Beygui F, Danse PW, Garachemani A, Del Blanco BG, Huber K, Koning R, Kukreja N, Piot C, Quang NN, Tirouvanziam A, Valla M, Smits PC, Valgimigli M, Master Dapt Investigators OBOT. Abbreviated or standard antiplatelet therapy after PCI in HBR patients with chronic kidney disease: a prespecified analysis from the MASTER DAPT trial. EuroIntervention. 2025 Dec 1;21(23):e1445-e1455. doi: 10.4244/EIJ-D-25-00566.

    PubMed 41342080

  • Bongiovanni D, Landi A, Frigoli E, Heg D, Chalkou K, Bartunek J, Delorme L, Dewilde W, Hildick-Smith D, Leibundgut G, Leonardi S, Lesiak M, Kala P, Kedev S, Roffi M, Stankovic G, Tonino PAL, Velchev V, Vranckx P, Windecker S, Smits PC, Valgimigli M; MASTER DAPT Investigators. Recurrent Events Analysis of MASTER DAPT: Total Ischemic and Bleeding Events After Abbreviated vs Prolonged DAPT in HBR Patients. J Am Coll Cardiol. 2025 Aug 19;86(7):485-498. doi: 10.1016/j.jacc.2025.05.010. Epub 2025 May 22.

    PubMed 40406944

  • Roffi M, Landi A, Heg D, Frigoli E, Chalkou K, Chevalier B, Ijsselmuiden AJJ, Kastberg R, Komiyama N, Morice MC, Onuma Y, Ozaki Y, Peace A, Pyxaras S, Sganzerla P, Williams R, Xaplanteris P, Vranckx P, Windecker S, Smits PC, Valgimigli M; MASTER DAPT Investigators. Abbreviated or Standard Antiplatelet Therapy After PCI in Diabetic Patients at High Bleeding Risk. JACC Cardiovasc Interv. 2024 Nov 25;17(22):2664-2677. doi: 10.1016/j.jcin.2024.08.030.

    PubMed 39603779

  • Ozaki Y, Hong SJ, Heg D, Frigoli E, Vranckx P, Morice MC, Chevalier B, Onuma Y, Windecker S, Di Biasi M, Whitbourn R, Dudek D, Raffel OC, Shimizu K, Calabro P, Frobert O, Cura F, Berg JT, Smits PC, Valgimigli M. Geographical Variations in the Effectiveness and Safety of Abbreviated or Standard Antiplatelet Therapy After Percutaneous Coronary Intervention in Patients at High Bleeding Risk. Can J Cardiol. 2024 Sep;40(9):1671-1674. doi: 10.1016/j.cjca.2024.01.032. Epub 2024 Feb 2. No abstract available.

    PubMed 38309468

  • Landi A, Alasnag M, Heg D, Frigoli E, Malik FTN, Gomez-Blazquez I, Pourbaix S, Chieffo A, Spaulding C, Sainz F, Routledge H, Ando G, Testa L, Sciahbasi A, Contractor H, Jepson N, Mieres J, Imran SS, Noor H, Smits PC, Valgimigli M; MASTER DAPT Investigators. Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial. JAMA Cardiol. 2024 Jan 1;9(1):35-44. doi: 10.1001/jamacardio.2023.4316.

    PubMed 37991745

  • Landi A, Heg D, Frigoli E, Vranckx P, Windecker S, Siegrist P, Cayla G, Wlodarczak A, Cook S, Gomez-Blazquez I, Feld Y, Seung-Jung P, Mates M, Lotan C, Gunasekaran S, Nanasato M, Das R, Kelbaek H, Teiger E, Escaned J, Ishibashi Y, Montalescot G, Matsuo H, Debeljacki D, Smits PC, Valgimigli M; MASTER DAPT Investigators. Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial. JACC Cardiovasc Interv. 2023 Apr 10;16(7):798-812. doi: 10.1016/j.jcin.2023.01.366.

    PubMed 37045500

  • Smits PC, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Paradies V, Kala P, Kedev S, Al Mafragi A, Dewilde W, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy After Coronary Stenting in Patients With Myocardial Infarction at High Bleeding Risk. J Am Coll Cardiol. 2022 Sep 27;80(13):1220-1237. doi: 10.1016/j.jacc.2022.07.016.

    PubMed 36137672

  • Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Delorme L, Kala P, Kedev S, Abhaichand RK, Velchev V, Dewilde W, Podolec J, Leibundgut G, Topic D, Schultz C, Stankovic G, Lee A, Johnson T, Tonino PAL, Klotzka A, Lesiak M, Lopes RD, Smits PC, Heg D; MASTER DAPT Investigators. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766-778. doi: 10.1016/j.jacc.2022.04.065.

    PubMed 35981821

  • Valgimigli M, Smits PC, Frigoli E, Bongiovanni D, Tijssen J, Hovasse T, Mafragi A, Ruifrok WT, Karageorgiev D, Aminian A, Garducci S, Merkely B, Routledge H, Ando K, Diaz Fernandez JF, Cuisset T, Nesa Malik FT, Halabi M, Belle L, Din J, Beygui F, Abhyankar A, Reczuch K, Pedrazzini G, Heg D, Vranckx P; MASTER DAPT Investigators. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis. Eur Heart J. 2022 Sep 1;43(33):3100-3114. doi: 10.1093/eurheartj/ehac284.

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  • Smits PC, Frigoli E, Tijssen J, Juni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iniguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M; MASTER DAPT Investigators. Abbreviated Antiplatelet Therapy in Patients at High Bleeding Risk With or Without Oral Anticoagulant Therapy After Coronary Stenting: An Open-Label, Randomized, Controlled Trial. Circulation. 2021 Oct 12;144(15):1196-1211. doi: 10.1161/CIRCULATIONAHA.121.056680. Epub 2021 Aug 29.

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Questions about this trial

What is this clinical trial studying?

A study testing Aspirin and P2Y12 inhibitor in people with High Bleeding Risk and Coronary Artery Disease, run by ECRI bv at 138 sites in 30 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 26 inclusion and 12 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 20 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in France, Italy, United Kingdom, Japan, Netherlands and 25 more countries. 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?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03023020, which also lists 17 linked publications.

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 20 Aug 2021.

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