- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04360720
PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial (NEOMINDSET)
PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial A Drug Reduction Study for Patients With Acute Coronary Syndrome in the Unified Health System in Brazil
Phase-3, randomized, multicenter, parallel-group study with blind evaluation of endpoints and intention-to-treat analysis.
The general purpose of the study is evaluate the non-inferiority hypothesis for ischemic events and the superiority hypothesis for bleeding events resulting from platelet P2Y12 receptor inhibitors given as monotherapy in comparison with conventional dual antiplatelet therapy in acute coronary syndrome patients treated with percutaneous coronary intervention in the context of the Unified Health System in Brazil.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Pedro A Lemos, MD
- Phone Number: +55 (11) 98317-5000
- Email: pedro.lemos@einstein.br
Study Contact Backup
- Name: Marcelo Franken, MD
- Phone Number: +55 (11) 99277-3509
- Email: marcelo.franken@einstein.br
Study Locations
-
-
-
Rio De Janeiro, Brazil
- Recruiting
- Instituto Estadual De Cardiologia Aloysio De Castro
-
Contact:
- Edgard Quintella, MD
-
São Paulo, Brazil, 05652- 900
- Recruiting
- Hospital Israelita Albert Einstein
-
Contact:
- Pedro A Lemos, MD
- Phone Number: +55 (11) 2151-0449
- Email: pedro.lemos@einstein.br
-
Sub-Investigator:
- Marcelo Franken, MD
-
São Paulo, Brazil
- Recruiting
- Hospital Sao Paulo - UNIFESP
-
Contact:
- Adriano Caixeta, MD, PhD
-
-
Acre
-
Rio Branco, Acre, Brazil
- Not yet recruiting
- Acurácia Serviços Médicos
-
Contact:
- Odilson Silvestre, MD, PhD
-
-
BA
-
Salvador, BA, Brazil
- Recruiting
- Hospital Ana Nery
-
Contact:
- Cristiano Guedes, MD, PhD
-
-
CE
-
Fortaleza, CE, Brazil
- Recruiting
- Hospital de Messejana Dr. Carlos Alberto Studart Gomes
-
Contact:
- João Falcão, MD
-
-
DF
-
Brasília, DF, Brazil
- Recruiting
- Hospital de Base de Brasília
-
Contact:
- Alberto Fonseca, MD
-
Brasília, DF, Brazil
- Recruiting
- Instituto Aramari APO
-
Contact:
- Alexandre Soares, MD
-
-
ES
-
Linhares, ES, Brazil
- Recruiting
- Instituto Cardiovascular de Linhares
-
Contact:
- João Tinoco de Paula, MD
-
Vila Velha, ES, Brazil
- Recruiting
- Hospital Evangélico de Vila Velha
-
Contact:
- José Arruda, MD
-
Vitória, ES, Brazil
- Recruiting
- Hospital Santa Casa de Misericórdia de Vitória
-
Contact:
- Renato Serpa, MD
-
-
GO
-
Goiânia, GO, Brazil
- Recruiting
- Universidade Federal de Goias
-
Contact:
- Weimar Souza, MD, PhD
-
-
MG
-
Belo Horizonte, MG, Brazil
- Recruiting
- Hospital Felicio Rocho
-
Contact:
- Jamil Saad, MD
-
Belo Horizonte, MG, Brazil
- Recruiting
- Hospital Madre Teresa
-
Contact:
- Marcos Marino, MD
-
Belo Horizonte, MG, Brazil
- Recruiting
- Hospital Universitário Ciências Médicas de Belo Horizonte
-
Contact:
- Bruno Ramos, MD, PhD
-
Poços De Caldas, MG, Brazil
- Recruiting
- Hospital Santa Lucía
-
Contact:
- Ricardo Bergo, MD
-
Uberaba, MG, Brazil
- Recruiting
- Hospital de Clínicas da Universidade Federal do Triângulo Mineiro
-
Contact:
- Fernando de Martino, MD
-
-
MS
-
Campo Grande, MS, Brazil
- Recruiting
- Hospital Universitario Maria Aparecida Pedrossian
-
Contact:
- Delcio Gonçalves, MD
-
-
Mato Grosso Do Sul
-
Campo Grande, Mato Grosso Do Sul, Brazil
- Not yet recruiting
- CASSEMS
-
Contact:
- Maria A Budib, MD
-
-
Minas Gerais
-
Belo Horizonte, Minas Gerais, Brazil
- Recruiting
- Instituto Orizonti
-
Contact:
- Estevão Figueiredo, MD
-
Juiz De Fora, Minas Gerais, Brazil
- Recruiting
- Eurolatino
-
Contact:
- Gustavo Ramalho, MD
-
Passos, Minas Gerais, Brazil
- Not yet recruiting
- Santa Casa da Misericórdia de Passos
-
Contact:
- Walter Alvarenga, MD
-
-
PE
-
Recife, PE, Brazil
- Recruiting
- Hospital Real Português
-
Contact:
- Gabriela Montenegro, MD
-
-
Paraná
-
Curitiba, Paraná, Brazil
- Recruiting
- Pontifícia Universidade Católica do Paraná
-
Contact:
- José R Fortes
-
-
Pernambuco
-
Recife, Pernambuco, Brazil
- Recruiting
- Instituto de Medicina Integral Professor Fernando Figueira - IMIP
-
Contact:
- Flavio Oliveira, MD
-
-
RJ
-
Rio De Janeiro, RJ, Brazil
- Recruiting
- Hospital sao lucas
-
Contact:
- Bruno Paolino, MD, PhD
-
Rio De Janeiro, RJ, Brazil
- Recruiting
- HUPE - Hospital Universitário Pedro Ernesto
-
Contact:
- Esmeralci Ferreira, MD, PhD
-
Rio De Janeiro, RJ, Brazil
- Recruiting
- Instituto Nacional de Cardiologia - INC
-
Contact:
- Fernanda Sampaio, MD
-
-
RS
-
Porto Alegre, RS, Brazil
- Recruiting
- Hospital de Clínicas de Porto Alegre
-
Contact:
- Marco Wainstein, MD, PhD
-
Porto Alegre, RS, Brazil
- Recruiting
- Hospital Sao Lucas da PUCRS
-
Contact:
- Paulo Caramori, MD
-
Porto Alegre, RS, Brazil
- Recruiting
- Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi
-
Contact:
- Rogério Sarmento Leite, MD, PhD
-
-
Rio Grande Do Norte
-
Natal, Rio Grande Do Norte, Brazil
- Recruiting
- Instituto Atena de Pesquisa
-
Contact:
- André Antonangelo, MD
-
-
SC
-
Florianópolis, SC, Brazil
- Recruiting
- Hospital Baia Sul
-
Contact:
- Rodrigo Joaquim, MD
-
Florianópolis, SC, Brazil
- Recruiting
- Hospital Instituto de Cardiologia de SC
-
Contact:
- Rodrigo Joaquim, MD
-
-
SE
-
Aracaju, SE, Brazil
- Recruiting
- Centro de Pesquisa Clinica do Coracao
-
Contact:
- Fabio Silveira, MD, PhD
-
-
SP
-
Bragança Paulista, SP, Brazil
- Recruiting
- Hospital Universitario Sao Francisco na Providencia de Deus
-
Contact:
- Murillo Antunes, MD, PhD
-
Campinas, SP, Brazil
- Recruiting
- Instituição, Hospital e Maternidade Celso Pierro
-
Contact:
- Aloisio Rocha, MD, PhD
-
Marilia, SP, Brazil
- Recruiting
- Irmandade da Santa Casa de Misericordia de Marilia
-
Contact:
- Pedro de Andrade, MD
-
Santos, SP, Brazil
- Recruiting
- Santa Casa da Misericórdia de Santos
-
Contact:
- Philipe Saccab, MD
-
São Paulo, SP, Brazil
- Recruiting
- Hospital 9 De Julho
-
Contact:
- Eduardo Lima, MD, PhD
-
São Paulo, SP, Brazil
- Recruiting
- Hospital Dante Pazzanese
-
Contact:
- Louis Ohe, MD
-
São Paulo, SP, Brazil
- Recruiting
- Instituto de Assistência Médica ao Servidor Público Estadual
-
Contact:
- George Ximenes, MD
-
São Paulo, SP, Brazil
- Recruiting
- Instituto do Coração - InCor
-
Contact:
- Remo Furtado, MD, PhD
-
São Paulo, SP, Brazil
- Recruiting
- Real e Benemérita Associação Portuguesa de Beneficência
-
Contact:
- José Mangione, MD, PhD
-
São Paulo, SP, Brazil
- Recruiting
- Santa Casa de São Paulo
-
Contact:
- Renato Alves, MD, PhD
-
-
São Paulo
-
Botucatu, São Paulo, Brazil
- Not yet recruiting
- UPECLIN
-
Contact:
- Marcos M Seki, MD
-
Campinas, São Paulo, Brazil
- Not yet recruiting
- Instituto de Pesquisa Clinica de Campinas
-
Contact:
- José F Saraiva, MD, PhD
-
Presidente Prudente, São Paulo, Brazil
- Recruiting
- Hospital Regional de Presidente Prudente
-
Contact:
- Charlene Nascimento, MD
-
São José Do Rio Preto, São Paulo, Brazil
- Recruiting
- Hospital de Base
-
Contact:
- Lilia Maia, MD, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Subjects must meet all the criteria below:
- Age >=18 years;
- Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before admission;
- Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
- Length of stay in hospital at randomization < 96 hours;
- Subjects will be informed about the nature of the study and must agree to comply and give an informed consent in writing using a form approved in advance by the local Ethics Committee.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
- Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically;
- Presence of residual lesions which are likely to require future treatment in the next 12 months;
- Fibrinolytic therapy < 24 hour before randomization;
- Need of oral anticoagulation with warfarin or new anticoagulants;
- Chronic bleeding diathesis;
- Active or recent major bleeding (in-hospital);
- Prior intracranial hemorrhage;
- Ischemic cerebrovascular accident < 30 days;
- Presence of brain arteriovenous malformation;
- Index event of non-atherothrombotic etiology (i.e., stent thrombosis, coronary embolism, spontaneous coronary artery dissection, myocardial ischemia due to supply/demand imbalance);
- Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
- Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
- Total white blood count < 3,000 cells/mm3;
- Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
- Receiver of heart transplant;
- Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
- Subject with life expectation lower than 1 year;
- Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;
- Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
- Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Dual Antiplatelet Therapy
Subjects randomized to Dual Antiplatelet Therapy Control Group will be treated with a regimen of acetylsalicylic acid combined with ticagrelor or prasugrel for 12 months. Acetylsalicylic acid (100 mg/day) + ticagrelor (90 mg twice daily) Or Acetylsalicylic acid (100 mg/day) + prasugrel (10 mg once daily) |
|
Experimental: Antiplatelet Monotherapy
All subjects randomized to Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to Monotherapy Group will be treated with ticagrelor or prasugrel alone for 12 months. Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (10 mg once daily) |
All subjects randomized to Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to Monotherapy Group will be treated with ticagrelor or prasugrel alone until the end of the study, at Month 12. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite endpoint of all-cause mortality, cerebrovascular accident, myocardial infarction or urgent target vessel revascularization.
Time Frame: 12 months
|
Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
|
12 months
|
Bleeding Academic Research Consortium (BARC) type-2, -3 or -5 bleeding event
Time Frame: 12 months
|
Co-Primary Safety Endpoint (superiority hypothesis)
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total of deaths, and cardiac and non-cardiac deaths
Time Frame: 12 months
|
Total of deaths, and cardiac and non-cardiac deaths
|
12 months
|
Sudden death
Time Frame: 30 days
|
Sudden death
|
30 days
|
Cerebrovascular accident
Time Frame: 12 months
|
Cerebrovascular accident
|
12 months
|
Myocardial Infarction
Time Frame: 12 months
|
Myocardial Infarction
|
12 months
|
Stent thrombosis
Time Frame: 12 months
|
Stent thrombosis
|
12 months
|
Non-scheduled invasive coronary treatment
Time Frame: 12 months
|
Non-scheduled invasive coronary treatment
|
12 months
|
BARC 1-5 type bleeding
Time Frame: 12 months
|
BARC 1-5 type bleeding
|
12 months
|
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
Time Frame: 12 months
|
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
|
12 months
|
Cost-effectiveness ratio
Time Frame: 12 months
|
Cost-effectiveness ratio
|
12 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Pedro A Lemos, MD, Hospital Israelita Albert Einstein
Publications and helpful links
General Publications
- Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. No abstract available.
- Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Juni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN; ESC Scientific Document Group; ESC Committee for Practice Guidelines (CPG); ESC National Cardiac Societies. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018 Jan 14;39(3):213-260. doi: 10.1093/eurheartj/ehx419. No abstract available.
- Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.
- Mahaffey KW, Wojdyla DM, Carroll K, Becker RC, Storey RF, Angiolillo DJ, Held C, Cannon CP, James S, Pieper KS, Horrow J, Harrington RA, Wallentin L; PLATO Investigators. Ticagrelor compared with clopidogrel by geographic region in the Platelet Inhibition and Patient Outcomes (PLATO) trial. Circulation. 2011 Aug 2;124(5):544-54. doi: 10.1161/CIRCULATIONAHA.111.047498. Epub 2011 Jun 27.
- Montalescot G, Wiviott SD, Braunwald E, Murphy SA, Gibson CM, McCabe CH, Antman EM; TRITON-TIMI 38 investigators. Prasugrel compared with clopidogrel in patients undergoing percutaneous coronary intervention for ST-elevation myocardial infarction (TRITON-TIMI 38): double-blind, randomised controlled trial. Lancet. 2009 Feb 28;373(9665):723-31. doi: 10.1016/S0140-6736(09)60441-4.
- Feres F, Costa RA, Siqueira D, Costa JR Jr, Chamie D, Staico R, Chaves AJ, Abizaid A, Marin-Neto JA, Rassi A Jr, Botelho R, Alves CMR, Saad JA, Mangione JA, Lemos PA, Quadros AS, Queiroga MAC, Cantarelli MJC, Figueira HR. DIRETRIZ DA SOCIEDADE BRASILEIRA DE CARDIOLOGIA E DA SOCIEDADE BRASILEIRA DE HEMODINAMICA E CARDIOLOGIA INTERVENCIONISTA SOBRE INTERVENCAO CORONARIA PERCUTANEA. Arq Bras Cardiol. 2017 Jun;109(1 Suppl 1):1-81. doi: 10.5935/abc.20170111. No abstract available. Portuguese.
- Serebruany VL, Steinhubl SR, Berger PB, Malinin AI, Baggish JS, Bhatt DL, Topol EJ. Analysis of risk of bleeding complications after different doses of aspirin in 192,036 patients enrolled in 31 randomized controlled trials. Am J Cardiol. 2005 May 15;95(10):1218-22. doi: 10.1016/j.amjcard.2005.01.049.
- Xian Y, Wang TY, McCoy LA, Effron MB, Henry TD, Bach RG, Zettler ME, Baker BA, Fonarow GC, Peterson ED. Association of Discharge Aspirin Dose With Outcomes After Acute Myocardial Infarction: Insights From the Treatment with ADP Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events after Acute Coronary Syndrome (TRANSLATE-ACS) Study. Circulation. 2015 Jul 21;132(3):174-81. doi: 10.1161/CIRCULATIONAHA.114.014992. Epub 2015 May 20.
- Colombo A, Hall P, Nakamura S, Almagor Y, Maiello L, Martini G, Gaglione A, Goldberg SL, Tobis JM. Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. Circulation. 1995 Mar 15;91(6):1676-88. doi: 10.1161/01.cir.91.6.1676.
- Vranckx P, Valgimigli M, Juni P, Hamm C, Steg PG, Heg D, van Es GA, McFadden EP, Onuma Y, van Meijeren C, Chichareon P, Benit E, Mollmann H, Janssens L, Ferrario M, Moschovitis A, Zurakowski A, Dominici M, Van Geuns RJ, Huber K, Slagboom T, Serruys PW, Windecker S; GLOBAL LEADERS Investigators. Ticagrelor plus aspirin for 1 month, followed by ticagrelor monotherapy for 23 months vs aspirin plus clopidogrel or ticagrelor for 12 months, followed by aspirin monotherapy for 12 months after implantation of a drug-eluting stent: a multicentre, open-label, randomised superiority trial. Lancet. 2018 Sep 15;392(10151):940-949. doi: 10.1016/S0140-6736(18)31858-0. Epub 2018 Aug 27.
- Kogame N, Modolo R, Tomaniak M, Cavalcante R, de Martino F, Tinoco J, Ribeiro EE, Mehran R, Campos CM, Onuma Y, Lemos PA, Serruys PW; Collaborators. Prasugrel monotherapy after PCI with the SYNERGY stent in patients with chronic stable angina or stabilised acute coronary syndromes: rationale and design of the ASET pilot study. EuroIntervention. 2019 Aug 9;15(6):e547-e550. doi: 10.4244/EIJ-D-19-00131. No abstract available.
- Valgimigli M, Garcia-Garcia HM, Vrijens B, Vranckx P, McFadden EP, Costa F, Pieper K, Vock DM, Zhang M, Van Es GA, Tricoci P, Baber U, Steg G, Montalescot G, Angiolillo DJ, Serruys PW, Farb A, Windecker S, Kastrati A, Colombo A, Feres F, Juni P, Stone GW, Bhatt DL, Mehran R, Tijssen JGP. Standardized classification and framework for reporting, interpreting, and analysing medication non-adherence in cardiovascular clinical trials: a consensus report from the Non-adherence Academic Research Consortium (NARC). Eur Heart J. 2019 Jul 1;40(25):2070-2085. doi: 10.1093/eurheartj/ehy377. Erratum In: Eur Heart J. 2019 Sep 1;40(33):2774. Eur Heart J. 2019 Jul 1;40(25):2086-2088.
- Myles PS, Smith JA, Forbes A, Silbert B, Jayarajah M, Painter T, Cooper DJ, Marasco S, McNeil J, Bussieres JS, Wallace S; ATACAS Investigators of the ANZCA Clinical Trials Network. Stopping vs. Continuing Aspirin before Coronary Artery Surgery. N Engl J Med. 2016 Feb 25;374(8):728-37. doi: 10.1056/NEJMoa1507688.
- Valgimigli M, Frigoli E, Leonardi S, Rothenbuhler M, Gagnor A, Calabro P, Garducci S, Rubartelli P, Briguori C, Ando G, Repetto A, Limbruno U, Garbo R, Sganzerla P, Russo F, Lupi A, Cortese B, Ausiello A, Ierna S, Esposito G, Presbitero P, Santarelli A, Sardella G, Varbella F, Tresoldi S, de Cesare N, Rigattieri S, Zingarelli A, Tosi P, van 't Hof A, Boccuzzi G, Omerovic E, Sabate M, Heg D, Juni P, Vranckx P; MATRIX Investigators. Bivalirudin or Unfractionated Heparin in Acute Coronary Syndromes. N Engl J Med. 2015 Sep 10;373(11):997-1009. doi: 10.1056/NEJMoa1507854. Epub 2015 Sep 1.
- Urban P, Mehran R, Colleran R, Angiolillo DJ, Byrne RA, Capodanno D, Cuisset T, Cutlip D, Eerdmans P, Eikelboom J, Farb A, Gibson CM, Gregson J, Haude M, James SK, Kim HS, Kimura T, Konishi A, Laschinger J, Leon MB, Magee PFA, Mitsutake Y, Mylotte D, Pocock S, Price MJ, Rao SV, Spitzer E, Stockbridge N, Valgimigli M, Varenne O, Windhoevel U, Yeh RW, Krucoff MW, Morice MC. Defining high bleeding risk in patients undergoing percutaneous coronary intervention: a consensus document from the Academic Research Consortium for High Bleeding Risk. Eur Heart J. 2019 Aug 14;40(31):2632-2653. doi: 10.1093/eurheartj/ehz372.
- Lansky AJ, Messe SR, Brickman AM, Dwyer M, Bart van der Worp H, Lazar RM, Pietras CG, Abrams KJ, McFadden E, Petersen NH, Browndyke J, Prendergast B, Ng VG, Cutlip DE, Kapadia S, Krucoff MW, Linke A, Scala Moy C, Schofer J, van Es GA, Virmani R, Popma J, Parides MK, Kodali S, Bilello M, Zivadinov R, Akar J, Furie KL, Gress D, Voros S, Moses J, Greer D, Forrest JK, Holmes D, Kappetein AP, Mack M, Baumbach A. Proposed Standardized Neurological Endpoints for Cardiovascular Clinical Trials: An Academic Research Consortium Initiative. Eur Heart J. 2018 May 14;39(19):1687-1697. doi: 10.1093/eurheartj/ehx037.
- 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.
- Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA; PLATO Investigators; Freij A, Thorsen M. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. N Engl J Med. 2009 Sep 10;361(11):1045-57. doi: 10.1056/NEJMoa0904327. Epub 2009 Aug 30.
- Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3992
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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Clinical Trials on Acute Coronary Syndrome
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Yonsei UniversityRecruitingCoronary Artery Disease, Acute Coronary SyndromeKorea, Republic of
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Meditrix CorpNational University of Ireland, Galway, Ireland; Boston Scientific Japan K.K.; Fujita Health UniversityRecruitingChronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromeJapan, Ireland
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OrbusNeichDuke Clinical Research Institute; OrbusNeich Medical K.K.CompletedCoronary Arteriosclerosis | Non ST Segment Elevation Acute Coronary SyndromeUnited States, Japan
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Medical University of WarsawRecruitingAcute Coronary Syndrome | Chronic Coronary Syndrome | Non ST Segment Elevation Acute Coronary SyndromePoland
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Eli Lilly and CompanyDaiichi Sankyo, Inc.CompletedCoronary Arteriosclerosis | Acute Coronary SyndromesUnited States
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University of PatrasCompletedCoronary Artery Disease (CAD) | Acute Coronary Syndrome (ACS)Greece
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Niguarda HospitalCompletedAcute Coronary Syndrome With ST Elevation on Electrocardiogram | Acute Coronary Syndrome Without ST Elevation on Electrocardiogram | Noncritical Coronary Artery Disease Coronary Stenosis Less Than 50 Per Cent | Aortic AneurysmsItaly
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Sohag UniversityRecruitingLeft Main Coronary Artery Disease With Acute Coronary SyndromeEgypt
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The First Affiliated Hospital with Nanjing Medical...Unknown
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Yonsei UniversityCompletedAcute Coronary Syndrome (ACS)Korea, Republic of
Clinical Trials on Antiplatelet Monotherapy
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The George Institute for Global Health, ChinaHuashan Hospital; University of Edinburgh; The University of Western AustraliaActive, not recruitingIntracerebral HemorrhageChina
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Josep Rodes-CabauRecruitingIschemic Stroke | Patent Foramen Ovale | Bleeding UlcerCanada
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Institute of Cardiology, Warsaw, PolandMedical Research Agency, PolandRecruitingAtrial FibrillationPoland
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National Institute of Cardiology, Warsaw, PolandMedical Research Agency, PolandRecruitingAtrial FibrillationPoland
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Asan Medical CenterSamsung Medical Center; Pusan National University Hospital; Chonnam National... and other collaboratorsRecruitingAtrial Fibrillation | Acute Ischemic Stroke | Anticoagulant | Coronary Artery Atherosclerosis | Intracranial Atherosclerosis | Extracranial Atherosclerosis | Antiplatelet | Peripheral Artery StenosisKorea, Republic of
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University of California, San FranciscoNot yet recruitingProstate Adenocarcinoma | Localized Prostate CarcinomaUnited States
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Xizang Haisco Pharmaceutical Co., LtdRecruiting
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Masonic Cancer Center, University of MinnesotaActive, not recruiting
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Centre Hospitalier Universitaire de Saint EtienneNot yet recruiting
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Peking Union Medical College HospitalCompletedChronic Periaortitis | Tocilizumab MonotherapyChina