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

NCT03023020 | Completed DMC

• 1 other identifier: ECRI-009
• Study Type: interventional
• Target: 4,579
• Locations: 26 countries
• Sites: 123

Brief 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). 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.

Conditions

High Bleeding Risk; Coronary Artery Disease; PCI

Keywords

Dual Antiplatelet Therapy

Outcome Measures

Primary Outcomes (3)

• 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

  11 months

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

  11 months

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

  11 months

Secondary Outcomes (11)

• All cause death

  14 months

• Death from cardiovascular causes

  14 months

• Myocardial infarction

  14 months

• Stroke

  14 months

• Bleeding events

  14 months

Study Arms (2)

Abbreviated antiplatelet regimen

OTHER

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; Drug: P2Y12 inhibitor

Prolonged antiplatelet regimen

OTHER

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; Drug: P2Y12 inhibitor

Interventions

Aspirin DRUG

Dosing per current guidelines and local practice

Also known as: antiplatelet agent

Abbreviated antiplatelet regimen; Prolonged antiplatelet regimen

P2Y12 inhibitor DRUG

Dosing per current guidelines and local practice

Also known as: antiplatelet agent

Abbreviated antiplatelet regimen; Prolonged antiplatelet regimen

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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:

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ECRI bv: lead
• Cardialysis B.V.: collaborator
• European Cardiovascular Research Center: collaborator
• University of Bern: collaborator
• Terumo Medical Corporation: collaborator

Study Sites (138)

Buenos Aires Research center

Buenos Aires, Argentina

Location

Interventional Cardiology Sanatorio

Buenos Aires, Argentina

Location

The Prince Charles Hospital

Chermside, Australia

Location

St Vincents Hospital Melbourne

Melbourne, Australia

Location

Research Center Perth

Perth, Australia

Location

Research Center Sydney

Sydney, Australia

Location

Wollongong Research Center

Wollongong, Australia

Location

Research Center , 043-02

Vienna, Austria

Location

Research Center, 043-01

Vienna, Austria

Location

Research Centre Manama

Manama, Bahrain

Location

Dhaka Research Center

Dhaka, Bangladesh

Location

Research Center Aalst

Aalst, Belgium

Location

Research Center Bonheiden

Bonheiden, Belgium

Location

CHU st.Pierre

Brussels, Belgium

Location

Research Centre Charleroi

Charleroi, Belgium

Location

Research Center Hasselt

Hasselt, Belgium

Location

Research Centre Liège

Liège, Belgium

Location

MHAT Sveta Karidad Plovdiv

Plovdiv, Bulgaria

Location

Sofia Resaerch Center, 359-02

Sofia, Bulgaria

Location

Sofia Research Center, 359-01

Sofia, Bulgaria

Location

Sofia Research Center, 359-03

Sofia, Bulgaria

Location

Research Center Brno

Brno, Czechia

Location

Research Center Phraha

Prague, Czechia

Location

Research Center Roskilde

Roskilde, Denmark

Location

Research Center Tallinn

Tallinn, Estonia

Location

Research Center Annecy

Annecy, France

Location

Hospital Prive Saint Martin

Caen, France

Location

Research Centre Caen

Caen, France

Location

Research Centre Créteil

Créteil, France

Location

Research Center Dijon

Dijon, France

Location

Hopital de la Timone

Marseille, France

Location

Research Center Massy

Massy, France

Location

Hospital de Mercy

Metz, France

Location

Research Center Montauban

Montauban, France

Location

Research Centre Montpellier

Montpellier, France

Location

Research Center Nantes

Nantes, France

Location

CHU Nimes

Nîmes, France

Location

Research Center Paris, 033-05

Paris, France

Location

Research Center Paris, 033-06

Paris, France

Location

Research Centre Rouen

Rouen, France

Location

Research Center Saint-Denis

Saint-Denis, France

Location

Saarland University

Homburg, Germany

Location

Cardiology Clinic

Landshut, Germany

Location

Research Centre Budapest

Budapest, Hungary

Location

Research Center Szeged

Szeged, Hungary

Location

Research Center Chennai, 091-01

Chennai, India

Location

Research Center Chennai, 091-05

Chennai, India

Location

Research Center Coimbatore

Coimbatore, India

Location

Research Center Surat

Sūrat, India

Location

Research Center Haifa

Haifa, Israel

Location

Research Center Jerusalem

Jerusalem, Israel

Location

Rabin MC

Petah Tikva, Israel

Location

Research Center Safed

Safed, Israel

Location

Ospedale Lorenzo Bonomo

Andria, Italy

Location

Azienda Ospedaliera Brotzu

Cagliari, Italy

Location

Second university of Naples Monaldi Hospital

Caserta, Italy

Location

Research Center Catania

Catania, Italy

Location

AOU Policlinico Gaetano Martino

Messina, Italy

Location

Niguarda

Milan, Italy

Location

Research Center Milan, 039-01

Milan, Italy

Location

Research Center Milan, 039-04

Milan, Italy

Location

Research Center Milan, 039-11

Milan, Italy

Location

San Donato Hospital

Milan, Italy

Location

Ospedale Sandro Pertini

Roma, Italy

Location

Policlinico Casilino

Rome, Italy

Location

Policlinico Umberto I

Rome, Italy

Location

Research Center Rozzano

Rozzano, Italy

Location

Clinic Cardiology

Treviglio, Italy

Location

Research Center Vimercate

Vimercate, Italy

Location

Kokura Memorial Hospital

Fukuoka, Japan

Location

Research Center Gifu

Gifu, Japan

Location

Ichinomiya Municipal Hospital

Ichinomiya, Japan

Location

St.Marianna University School of Medicine

Kawasaki, Japan

Location

Aichi Medical University Hospital

Nagakute, Japan

Location

Japan Red Cross Nagoya Daiichi Hospital (1st)

Nagoya, Japan

Location

Japan Red Cross Nagoya Daini Hospital (2nd)

Nagoya, Japan

Location

Nagoya University Hospital

Nagoya, Japan

Location

Osaka police Hospital

Osaka, Japan

Location

St.Luke's International Hospital

Tokyo, Japan

Location

Research Center Toyoake

Toyoake, Japan

Location

Research Center Den Bosch

's-Hertogenbosch, Netherlands

Location

Research Centre Arnhem

Arnhem, Netherlands

Location

Research Center Breda

Breda, Netherlands

Location

Research Centre Dordrecht

Dordrecht, Netherlands

Location

Research Centre Eindhoven

Eindhoven, Netherlands

Location

Research Center Emmen

Emmen, Netherlands

Location

Research Centre Enschede

Enschede, Netherlands

Location

Antonius ziekenhuis

Nieuwegein, Netherlands

Location

Research Center Rotterdam

Rotterdam, Netherlands

Location

Research Centre Terneuzen

Terneuzen, Netherlands

Location

Haga Hospital

The Hague, Netherlands

Location

Research Center Skopje

Skopje, North Macedonia

Location

Research Center Krakow

Krakow, Poland

Location

University Hospital Krakow

Krakow, Poland

Location

Miedziowe Centrum Zdrowia SA

Lubin, Poland

Location

Research Center Poznan

Poznan, Poland

Location

Research Centre Wroclaw

Wroclaw, Poland

Location

Research Center Jeddah

Jeddah, Saudi Arabia

Location

Research Center Riyadh

Riyadh, Saudi Arabia

Location

Researcg Center Belgrade, 381-02

Belgrade, Serbia

Location

Research Center of Serbia, 381-01

Belgrade, Serbia

Location

Research Center Sremska Kamenica

Kamenitz, Serbia

Location

Singapore Research Center

Singapore, Singapore

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Ljubljana Research Center

Ljubljana, Slovenia

Location

Research Center Seoul

Seoul, South Korea

Location

Research Center Alicante

Alicante, Spain

Location

Research Center Barcelona, 034-07

Barcelona, Spain

Location

Research Center Barcelona, 034-09

Barcelona, Spain

Location

Universitario Virgen de la Arrixaca

El Palmar, Spain

Location

Research Center Huelva

Huelva, Spain

Location

Hospital Universitario Puerta de hierro

Madrid, Spain

Location

Research Center Madrid, 034-06

Madrid, Spain

Location

Research Center Madrid, 034-10

Madrid, Spain

Location

Hospital Universitario Valdecilla

Santander, Spain

Location

Research Center Vigo

Vigo, Spain

Location

Research Center Gavle

Gävle, Sweden

Location

Research Center Orebro

Örebro, Sweden

Location

Lindenhofspital

Bern, Switzerland

Location

Research Centre Bern

Bern, Switzerland

Location

Research Centre Fribourg

Fribourg, Switzerland

Location

University Hospital Geneva

Geneva, Switzerland

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Research Centre Liestal

Liestal, Switzerland

Location

Research Centre Lugano

Lugano, Switzerland

Location

Research Centre Zürich

Zurich, Switzerland

Location

Research Center Blackburn

Blackburn, United Kingdom

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Research Center Bournemouth

Bournemouth, United Kingdom

Location

Research Centre Brighton

Brighton, United Kingdom

Location

Bristol Heart Institute

Bristol, United Kingdom

Location

St George's Hospital

London, United Kingdom

Location

Altnagelvin Hospital

Londonderry, United Kingdom

Location

Manchester Research Center

Manchester, United Kingdom

Location

Research Center Newcastle

Newcastle upon Tyne, United Kingdom

Location

Research Center Stevenage

Stevenage, United Kingdom

Location

Research Centre Stoke-on-Trent

Stoke-on-Trent, United Kingdom

Location

Research Centre Wolverhampton

Wolverhampton, United Kingdom

Location

Research Centre Worcester

Worcester, United Kingdom

Location

Vietnam National Heart Institute

Hanoi, Vietnam

Location

Related Publications (15)

• 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.

  PMID: 25173339 BACKGROUND

• 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.

  PMID: 26320110 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 41342080 DERIVED

• 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.

  PMID: 40406944 DERIVED

• 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.

  PMID: 39603779 DERIVED

• 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.

  PMID: 37991745 DERIVED

• 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.

  PMID: 37045500 DERIVED

• 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.

  PMID: 36137672 DERIVED

• 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.

  PMID: 35981821 DERIVED

• 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.

  PMID: 35580836 DERIVED

• 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.

  PMID: 34455849 DERIVED

• Valgimigli M, Frigoli E, Heg D, 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, Donahue M, Leonardi S, Smits PC; MASTER DAPT Investigators. Dual Antiplatelet Therapy after PCI in Patients at High Bleeding Risk. N Engl J Med. 2021 Oct 28;385(18):1643-1655. doi: 10.1056/NEJMoa2108749. Epub 2021 Aug 28.

  PMID: 34449185 DERIVED

• Vlieger S, Danzi GB, Kauer F, Oemrawsingh RM, Stojkovic S, IJsselmuiden AJJ, Routledge H, Laanmets P, Roffi M, Frobert O, Baello P, Wlodarczak A, Puentes A, Polad J, Hildick-Smith D. One-year performance of thin-strut cobalt chromium sirolimus-eluting stent versus thicker strut stainless steel biolimus-eluting coronary stent: a propensity-matched analysis of two international all-comers registries. Coron Artery Dis. 2021 Aug 1;32(5):391-396. doi: 10.1097/MCA.0000000000000958.

  PMID: 33060529 DERIVED

• Frigoli E, Smits P, Vranckx P, Ozaki Y, Tijssen J, Juni P, Morice MC, Onuma Y, Windecker S, Frenk A, Spaulding C, Chevalier B, Barbato E, Tonino P, Hildick-Smith D, Roffi M, Kornowski R, Schultz C, Lesiak M, Iniguez A, Colombo A, Alasnag M, Mullasari A, James S, Stankovic G, Ong PJL, Rodriguez AE, Mahfoud F, Bartunek J, Moschovitis A, Laanmets P, Leonardi S, Heg D, Sunnaker M, Valgimigli M. Design and rationale of the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Standard DAPT Regimen (MASTER DAPT) Study. Am Heart J. 2019 Mar;209:97-105. doi: 10.1016/j.ahj.2018.10.009. Epub 2018 Nov 22.

  PMID: 30703644 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Aspirin; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Officials

• M. Valgimigli, Prof.

  Cardiocentro Ticino Foundation, Lugano, Switzerland

  PRINCIPAL INVESTIGATOR

• P. Smits, Dr.

  Maasstad Ziekenhuis Rotterdam, The Netherlands

  PRINCIPAL INVESTIGATOR

• E. Spitzer, Dr.

  ECRI bv

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 18, 2017
• Study Start: April 4, 2017
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: August 20, 2021

Record last verified: 2021-08

Locations

BE (6); CZ (2); SG (2); BA (1); SL (1); AU (5); NL (11); BU (4); JP (11); NO (1); KR (1); SE (3); IT (16); IL (4); DE (2); GB (12); ES (1); SA (2); AR (2); IN (4); PL (5); FR (16); HU (2); VN (1); DK (1); CH (7)