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Acute Coronary SyndromePhase 3NEOMINDSETNCT04360720

Percutaneous Coronary Intervention Followed by Antiplatelet Monotherapy in the Setting of Acute Coronary Syndromes

A Phase 3 study testing Antiplatelet Monotherapy in people with Acute Coronary Syndrome, run by Hospital Israelita Albert Einstein at 50 sites in Brazil.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Coronary Syndrome
What is being tested?
Antiplatelet Monotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,410 participants
Where
50 sitesBrazil
Study dates
15 Oct 2020to 30 Dec 2024
Phase
Phase 3
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

  • Subjects must meet all the criteria below:
  • Age >=18 years;
  • Acute coronary syndrome with last symptoms < 24 hours before hospital 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.

Who cannot join

  • Subjects meeting any of the following criteria will be excluded:
  • Acute coronary syndrome on index admission treated conservatively or with unsuccessful percutaneous intervention or coronary artery bypass graft;
  • 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;
Show all 21Show fewer
  • Active or recent major bleeding (in-hospital);
  • Prior intracranial hemorrhage;
  • Ischemic stroke < 30 days;
  • Presence of brain arteriovenous malformation;
  • Index event of non-atherothrombotic etiology (i.e., stent thrombosis, in-stent restenosis, 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 to 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 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.

Trial locations and contacts

50 sites in 1 country.

50 sites in 1 country

Brazil50 sites

  • Centro de Pesquisa Clínica do Coração

    Aracaju, Sergipe

  • Hospital Felício Rocho

    Belo Horizonte, Minas Gerais

  • Hospital Madre Teresa

    Belo Horizonte, Minas Gerais

  • Hospital Universitário Ciências Médicas de Belo Horizonte

    Belo Horizonte, Minas Gerais

  • Instituto Orizonti

    Belo Horizonte, Minas Gerais

  • UPECLIN

    Botucatu, São Paulo

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, São Paulo

  • Hospital de Base de Brasília

    Brasília, Federal District

  • Instituto Aramari APO

    Brasília, Federal District

  • Instituição, Hospital e Maternidade Celso Pierro

    Campinas, São Paulo

  • Instituto De Pesquisa Clinica de Campinas

    Campinas, São Paulo

  • UNICAMP

    Campinas, São Paulo

  • CASSEMS

    Campo Grande, Mato Grosso do Sul

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, Mato Grosso do Sul

  • Pontifícia Universidade Católica do Paraná

    Curitiba, Paraná

  • Hospital Baia Sul

    Florianópolis, Santa Catarina

  • Hospital Instituto de Cardiologia de SC

    Florianópolis, Santa Catarina

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, Ceará

  • Hospital Municipal Aparecida de Goiania

    Goiânia, Goiás

  • Universidade Federal de Goiás

    Goiânia, Goiás

  • Eurolatino

    Juiz de Fora, Minas Gerais

  • Instituto Cardiovascular de Linhares

    Linhares, Espírito Santo

  • Irmandade da Santa Casa de Misericórdia de Marilia

    Marília, São Paulo

  • Instituto Atena de Pesquisa

    Natal, Rio Grande do Norte

  • Hospital Municipal Antonio Giglio

    Osasco, São Paulo

  • Santa Casa da Misericórdia de Passos

    Passos, Minas Gerais

  • Hospital Santa Lucia

    Poços de Caldas, Minas Gerais

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul

  • Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi

    Porto Alegre, Rio Grande do Sul

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, São Paulo

  • Hospital Real Português

    Recife, Pernambuco

  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP

    Recife, Pernambuco

  • Hospital São Lucas

    Rio de Janeiro, Rio de Janeiro

  • HUPE - Hospital Universitário Pedro Ernesto

    Rio de Janeiro, Rio de Janeiro

  • Instituto Estadual de Cardiologia Aloysio de Castro

    Rio de Janeiro, Rio de Janeiro

  • Instituto Nacional de Cardiologia - INC

    Rio de Janeiro, Rio de Janeiro

  • Hospital Ana Nery

    Salvador, Estado de Bahia

  • Santa Casa da Misericórdia de Santos

    Santos, São Paulo

  • Hospital de Base

    São José do Rio Preto, São Paulo

  • Hospital Israelita Albert Einstein

    São Paulo, São Paulo, 05652- 900

  • Hospital 9 de Julho

    São Paulo, São Paulo

  • Hospital Dante Pazzanese

    São Paulo, São Paulo

  • Hospital São Paulo - Unifesp

    São Paulo, São Paulo

  • Instituto de Assistência Médica ao Servidor Público Estadual

    São Paulo, São Paulo

  • Instituto do Coração - InCor

    São Paulo, São Paulo

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, São Paulo

  • Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

    Uberaba, Minas Gerais

  • Hospital Evangélico de Vila Velha

    Vila Velha, Espírito Santo

  • Hospital Santa Casa de Misericórdia de Vitória

    Vitória, Espírito Santo

Other trials in Brazil

About this study

Official title: PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial

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.

Read the detailed description

Based on current scientific evidence, acute coronary syndrome subjects should be treated with dual antiplatelet therapy, which consists of the association of acetylsalicylic acid with an oral antagonist of platelet P2Y12 receptor. Clinical trials have shown that dual antiplatelet therapy reduces ischemic events, despite of increasing the risk of bleeding complications. Because dual antiplatelet therapy has a positive net effect, such an approach is currently recommended by international guidelines and recognized as the therapy of choice for acute coronary syndrome subjects. It is known that the acetylsalicylic acid dose is directly proportional to the bleeding risk. However, so far, all new antiplatelet drugs have been tested and used in association with acetylsalicylic acid for a varying period of time. This study is carried out in such context and intends to evaluate the clinical performance of new inhibitors of platelet P2Y12 receptor given solely, as monotherapy, to acute coronary syndrome patients, to test the hypothesis that an antithrombotic monotherapy with such agents (i.e., acetylsalicylic acid withdrawal) sustains efficacy by preventing ischemic complications while reducing the bleeding potential of this drug dosage regimens. It is a Phase-3, randomized, multicenter, parallel-group study with blind evaluation of endpoints and intention-to-treat analysis. Subjects with acute coronary syndrome treated with a successful percutaneous coronary intervention will be enrolled. The general purpose of the study is to test 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 the context of the Unified Health System in Brazil.

Being tested
Antiplatelet Monotherapy
Keywords
Acute Coronary Syndrome, Antithrombotic Therapy, Dual Antiplatelet Therapy with acetylsalicylic acid, Monotherapy without acetylsalicylic acid
Medical subject headings
Acute Coronary Syndrome

What participants receive

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

  • Antiplatelet MonotherapyDrug

    Also called Monotherapy

    All subjects randomized to the Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization.

    Subjects randomized to the Monotherapy Group will be treated with ticagrelor or prasugrel alone until the end of the study, at Month 12.

Study groups in NCT04360720
Study groupRoleWhat they receive
Dual Antiplatelet TherapyNo interventionSubjects randomized to the 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 (5mg or 10 mg once daily)
Antiplatelet MonotherapyExperimentalAll subjects randomized to the Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization. Subjects randomized to the Monotherapy Group will be treated with ticagrelor or prasugrel alone for 12 months. Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (5 or 10 mg once daily)
Receives: Drug: Antiplatelet Monotherapy

What is being measured

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

  1. Composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularization.

    Co-Primary Efficacy Endpoint (non-inferiority hypothesis)

    Measured: 12 months

  2. Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding event

    Co-Primary Safety Endpoint (superiority hypothesis)

    Measured: 12 months

Secondary outcomes (9)

  1. All-cause death, cardiovascular death and non-cardiovascular death

    All-cause death, cardiovascular death and non-cardiovascular death

    Measured: 12 months

  2. Sudden death

    Sudden death

    Measured: 30 days

  3. Stroke

    Stroke

    Measured: 12 months

  4. Myocardial Infarction

    Myocardial Infarction

    Measured: 12 months

  5. Stent thrombosis

    Stent thrombosis

    Measured: 12 months

  6. Unscheduled invasive coronary treatment

    Unscheduled invasive coronary treatment

    Measured: 12 months

  7. BARC 1-5 type bleeding

    BARC 1-5 type bleeding

    Measured: 12 months

  8. Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)

    Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)

    Measured: 12 months

  9. Cost-effectiveness ratio

    Cost-effectiveness ratio

    Measured: 12 months

Timeline

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

  1. First posted24 Apr 2020
  2. Study start15 Oct 2020
  3. Primary completion30 Nov 2024
  4. Study completion30 Dec 2024

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,410 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04360720
Sponsor's protocol ID
3992
Acronym
NEOMINDSET
Status last verified
Jun 2025
First submitted
22 Apr 2020
Last updated
3 Jul 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Guimaraes PO, Franken M, Tavares CAM, Silveira FS, Antunes MO, Bergo RR, Joaquim RM, Hirai JCS, Andrade PB, Pitta FG, Mariani J Jr, Nascimento BR, de Paula JET, Silveira MS, Costa TAO, Dall'Orto FTC, Serpa RG, Sampaio FBA, Ohe LN, Mangione FM, Furtado RHM, Sarmento-Leite R, Monfardini F, Assis SRL, Nicolau JC, Sposito AC, Lopes RD, Onuma Y, Valgimigli M, Angiolillo DJ, Serruys PW, Berwanger O, Bacal F, Lemos PA. P2Y12 inhibitor monotherapy versus dual antiplatelet therapy in patients with acute coronary syndromes undergoing coronary stenting: rationale and design of the NEOMINDSET Trial. EuroIntervention. 2023 Jul 17;19(4):e323-e329. doi: 10.4244/EIJ-D-23-00125.

    PubMed 37306039

  • 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.

    PubMed 28886622

  • 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.

    PubMed 19249633

  • 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.

    PubMed 19717846

  • 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.

    PubMed 28792984

  • 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.

    PubMed 15877994

  • 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.

    PubMed 25995313

  • 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.

    PubMed 21709065

  • 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.

    PubMed 7882474

  • 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.

    PubMed 30166073

  • 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.

    PubMed 31012851

  • 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.

    PubMed 21670242

  • 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.

    PubMed 29992264

  • 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.

    PubMed 26933848

  • 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.

    PubMed 26324049

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Antiplatelet Monotherapy in people with Acute Coronary Syndrome, run by Hospital Israelita Albert Einstein at 50 sites in Brazil.

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 6 inclusion and 21 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 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 sites in Brazil. 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Composite endpoint of all-cause mortality, stroke, myocardial infarction or urgent target vessel revascularization. (time frame: 12 months). The study lists 2 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 NCT04360720, which also lists 23 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 3 Jul 2025.

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