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

June 30, 2025 updated by: Hospital Israelita Albert Einstein

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3410

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio De Janeiro, Brazil
        • Instituto Estadual de Cardiologia Aloysio de Castro
      • São Paulo, Brazil
        • Hospital São Paulo - UNIFESP
      • São Paulo, Brazil, 05652- 900
        • Hospital Israelita Albert Einstein
    • BA
      • Salvador, BA, Brazil
        • Hospital Ana Nery
    • CE
      • Fortaleza, CE, Brazil
        • Hospital de Messejana Dr. Carlos Alberto Studart Gomes
    • DF
      • Brasília, DF, Brazil
        • Hospital de Base de Brasília
      • Brasília, DF, Brazil
        • Instituto Aramari Apo
    • ES
      • Linhares, ES, Brazil
        • Instituto Cardiovascular de Linhares
      • Vila Velha, ES, Brazil
        • Hospital Evangélico de Vila Velha
      • Vitória, ES, Brazil
        • Hospital Santa Casa de Misericórdia de Vitória
    • GO
      • Goiânia, GO, Brazil
        • Universidade Federal de Goias
      • Goiânia, GO, Brazil
        • Hospital Municipal Aparecida de Goiânia
    • MG
      • Belo Horizonte, MG, Brazil
        • Hospital Felicio Rocho
      • Belo Horizonte, MG, Brazil
        • Hospital Madre Teresa
      • Belo Horizonte, MG, Brazil
        • Hospital Universitário Ciências Médicas de Belo Horizonte
      • Poços De Caldas, MG, Brazil
        • Hospital Santa Lucía
      • Uberaba, MG, Brazil
        • Hospital de Clínicas da Universidade Federal do Triângulo Mineiro
    • MS
      • Campo Grande, MS, Brazil
        • Hospital Universitario Maria Aparecida Pedrossian
    • Mato Grosso do Sul
      • Campo Grande, Mato Grosso do Sul, Brazil
        • CASSEMS
    • Minas Gerais
      • Juiz De Fora, Minas Gerais, Brazil
        • Eurolatino
      • Passos, Minas Gerais, Brazil
        • Santa Casa da Misericórdia de Passos
    • Minas gerais
      • Belo Horizonte, Minas gerais, Brazil
        • Instituto Orizonti
    • PE
      • Recife, PE, Brazil
        • Hospital Real Português
    • Paraná
      • Curitiba, Paraná, Brazil
        • Pontificia Universidade Catolica do Parana
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Instituto de Medicina Integral Professor Fernando Figueira - IMIP
    • RJ
      • Rio De Janeiro, RJ, Brazil
        • Hospital São Lucas
      • Rio De Janeiro, RJ, Brazil
        • HUPE - Hospital Universitário Pedro Ernesto
      • Rio De Janeiro, RJ, Brazil
        • Instituto Nacional de Cardiologia - INC
    • RS
      • Porto Alegre, RS, Brazil
        • Hospital de Clinicas de Porto Alegre
      • Porto Alegre, RS, Brazil
        • Hospital Sao Lucas Da Pucrs
      • Porto Alegre, RS, Brazil
        • Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil
        • Instituto Atena de Pesquisa
    • SC
      • Florianópolis, SC, Brazil
        • Hospital Baia Sul
      • Florianópolis, SC, Brazil
        • Hospital Instituto de Cardiologia de SC
    • SE
      • Aracaju, SE, Brazil
        • Centro de Pesquisa Clinica do Coracao
    • SP
      • Bragança Paulista, SP, Brazil
        • Hospital Universitário São Francisco na Providência de Deus
      • Campinas, SP, Brazil
        • Instituição, Hospital e Maternidade Celso Pierro
      • Campinas, SP, Brazil
        • Unicamp
      • Marilia, SP, Brazil
        • Irmandade da Santa Casa de Misericórdia de Marília
      • Osasco, SP, Brazil
        • Hospital Municipal Antonio Giglio
      • Santos, SP, Brazil
        • Santa Casa da Misericórdia de Santos
      • São Paulo, SP, Brazil
        • Instituto de Assistência Médica ao Servidor Público Estadual
      • São Paulo, SP, Brazil
        • Hospital 9 de Julho
      • São Paulo, SP, Brazil
        • Hospital Dante Pazzanese
      • São Paulo, SP, Brazil
        • Instituto do Coração - InCor
      • São Paulo, SP, Brazil
        • Real e Benemerita Associacao Portuguesa de Beneficencia
    • São Paulo
      • Botucatu, São Paulo, Brazil
        • UPECLIN
      • Campinas, São Paulo, Brazil
        • Instituto de Pesquisa clinica de Campinas
      • Presidente Prudente, São Paulo, Brazil
        • Hospital Regional de Presidente Prudente
      • São José Do Rio Preto, São Paulo, Brazil
        • Hospital de Base

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Subjects must meet all the criteria below:

  1. Age >=18 years;
  2. Acute coronary syndrome with last symptoms < 24 hours before hospital admission;
  3. Successful percutaneous coronary intervention(s) of all target lesions (culprit and non-culprit) with new-generation drug-eluting stents;
  4. Length of stay in hospital at randomization < 96 hours;
  5. 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:

  1. Acute coronary syndrome on index admission treated conservatively or with unsuccessful percutaneous intervention or coronary artery bypass graft;
  2. Presence of residual lesions which are likely to require future treatment in the next 12 months;
  3. Fibrinolytic therapy < 24 hour before randomization;
  4. Need of oral anticoagulation with warfarin or new anticoagulants;
  5. Chronic bleeding diathesis;
  6. Active or recent major bleeding (in-hospital);
  7. Prior intracranial hemorrhage;
  8. Ischemic stroke < 30 days;
  9. Presence of brain arteriovenous malformation;
  10. 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);
  11. Potential or scheduled cardiac or non-cardiac surgery in the next 12 months;
  12. Platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3;
  13. Total white blood count < 3,000 cells/mm3;
  14. Suspected or documented active liver disease (including laboratory evidence of hepatitis B or C);
  15. Receiver of heart transplant;
  16. Known allergies or intolerance to acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
  17. Subject with life expectation lower than 1 year;
  18. Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation in the study;
  19. Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
  20. Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Dual Antiplatelet Therapy

Subjects 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)
Experimental: Antiplatelet 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 for 12 months.

Ticagrelor alone (90 mg twice daily) Or Prasugrel alone (5 or 10 mg once daily)
Drug: Antiplatelet 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.

Other Names:
  • Monotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite endpoint of all-cause mortality, stroke, 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
Sudden death
Time Frame: 30 days
Sudden death
30 days
Myocardial Infarction
Time Frame: 12 months
Myocardial Infarction
12 months
Stent thrombosis
Time Frame: 12 months
Stent thrombosis
12 months
BARC 1-5 type bleeding
Time Frame: 12 months
BARC 1-5 type bleeding
12 months
Cost-effectiveness ratio
Time Frame: 12 months
Cost-effectiveness ratio
12 months
Stroke
Time Frame: 12 months
Stroke
12 months
All-cause death, cardiovascular death and non-cardiovascular death
Time Frame: 12 months
All-cause death, cardiovascular death and non-cardiovascular death
12 months
Unscheduled invasive coronary treatment
Time Frame: 12 months
Unscheduled invasive coronary treatment
12 months
Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)
Time Frame: 12 months
Net adverse clinical events (occurrence of all-cause death, myocardial infarction, stroke, urgent target-vessel revascularization, BARC 2, 3 or 5 bleeding)
12 months

Collaborators and Investigators

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

Sponsor

Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Pedro A Lemos, MD, Hospital Israelita Albert Einstein

Publications and helpful links

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

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2020

Primary Completion (Actual)

November 30, 2024

Study Completion (Actual)

December 30, 2024

Study Registration Dates

First Submitted

April 22, 2020

First Submitted That Met QC Criteria

April 23, 2020

First Posted (Actual)

April 24, 2020

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

June 30, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3992

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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