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

February 15, 2023 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 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

Recruiting

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 (Anticipated)

3400

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 Contact

Study Contact Backup

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:
        • 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

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subjects must meet all the criteria below:

  1. Age >=18 years;
  2. Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before 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 in a conservative way or by unsuccessful percutaneous intervention or surgically;
  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 cerebrovascular accident < 30 days;
  9. Presence of brain arteriovenous malformation;
  10. Index event of non-atherothrombotic etiology (i.e., stent thrombosis, 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 of 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 of the subject 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 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

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

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 (Anticipated)

January 30, 2024

Study Completion (Anticipated)

January 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)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

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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