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

NCT04360720 | Completed Phase 3 DMC

• 1 other identifier: 3992
• Study Type: interventional
• Target: 3,410
• Locations: 1 country
• Sites: 50

Brief 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 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.

Conditions

Acute Coronary Syndrome

Keywords

Acute Coronary Syndrome; Antithrombotic Therapy; Dual Antiplatelet Therapy with acetylsalicylic acid; Monotherapy without acetylsalicylic acid

Outcome Measures

Primary Outcomes (2)

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

  Co-Primary Efficacy Endpoint (non-inferiority hypothesis)

  12 months

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

  Co-Primary Safety Endpoint (superiority hypothesis)

  12 months

Secondary Outcomes (9)

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

  12 months

• Sudden death

  30 days

• Stroke

  12 months

• Myocardial Infarction

  12 months

• Stent thrombosis

  12 months

Study Arms (2)

Dual Antiplatelet Therapy

NO INTERVENTION

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)

Antiplatelet Monotherapy

EXPERIMENTAL

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

Interventions

Antiplatelet Monotherapy DRUG

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.

Also known as: Monotherapy

Antiplatelet Monotherapy

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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);

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead

Study Sites (50)

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Fortaleza, Ceará, Brazil

Location

Instituto Cardiovascular de Linhares

Linhares, Espírito Santo, Brazil

Location

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Location

Hospital Santa Casa de Misericórdia de Vitória

Vitória, Espírito Santo, Brazil

Location

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Location

Hospital de Base de Brasília

Brasília, Federal District, Brazil

Location

Instituto Aramari APO

Brasília, Federal District, Brazil

Location

Hospital Municipal Aparecida de Goiania

Goiânia, Goiás, Brazil

Location

Universidade Federal de Goiás

Goiânia, Goiás, Brazil

Location

CASSEMS

Campo Grande, Mato Grosso do Sul, Brazil

Location

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Location

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Location

Hospital Universitário Ciências Médicas de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Location

Instituto Orizonti

Belo Horizonte, Minas Gerais, Brazil

Location

Eurolatino

Juiz de Fora, Minas Gerais, Brazil

Location

Santa Casa da Misericórdia de Passos

Passos, Minas Gerais, Brazil

Location

Hospital Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Location

Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, Brazil

Location

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Location

Hospital Real Português

Recife, Pernambuco, Brazil

Location

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernambuco, Brazil

Location

Hospital São Lucas

Rio de Janeiro, Rio de Janeiro, Brazil

Location

HUPE - Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Instituto Estadual de Cardiologia Aloysio de Castro

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Instituto Nacional de Cardiologia - INC

Rio de Janeiro, Rio de Janeiro, Brazil

Location

Instituto Atena de Pesquisa

Natal, Rio Grande do Norte, Brazil

Location

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Location

Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi

Porto Alegre, Rio Grande do Sul, Brazil

Location

Hospital Baia Sul

Florianópolis, Santa Catarina, Brazil

Location

Hospital Instituto de Cardiologia de SC

Florianópolis, Santa Catarina, Brazil

Location

Centro de Pesquisa Clínica do Coração

Aracaju, Sergipe, Brazil

Location

UPECLIN

Botucatu, São Paulo, Brazil

Location

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Location

Instituição, Hospital e Maternidade Celso Pierro

Campinas, São Paulo, Brazil

Location

Instituto De Pesquisa Clinica de Campinas

Campinas, São Paulo, Brazil

Location

UNICAMP

Campinas, São Paulo, Brazil

Location

Irmandade da Santa Casa de Misericórdia de Marilia

Marília, São Paulo, Brazil

Location

Hospital Municipal Antonio Giglio

Osasco, São Paulo, Brazil

Location

Hospital Regional de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

Location

Santa Casa da Misericórdia de Santos

Santos, São Paulo, Brazil

Location

Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Location

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05652- 900, Brazil

Location

Hospital 9 de Julho

São Paulo, São Paulo, Brazil

Location

Hospital Dante Pazzanese

São Paulo, São Paulo, Brazil

Location

Hospital São Paulo - Unifesp

São Paulo, São Paulo, Brazil

Location

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, São Paulo, Brazil

Location

Instituto do Coração - InCor

São Paulo, São Paulo, Brazil

Location

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, São Paulo, Brazil

Location

Related Publications (22)

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• Guimaraes PO, Franken M, Tavares CAM, Antunes MO, Silveira FS, Andrade PB, Bergo RR, Joaquim RM, Tinoco de Paula JE, Nascimento BR, Pitta FG, Arruda JA, Serpa RG, Ohe LN, Mangione FM, Furtado RHM, Ferreira E, Sampaio FBA, T do Nascimento C, Genelhu LOO, Bezerra CG, Sarmento-Leite R, Maia LN, Oliveira FRA, Wainstein MV, Dall'Orto FTC, Monfardini F, Assis SRL, Nicolau JC, Sposito AC, Lopes RD, Onuma Y, Valgimigli M, Angiolillo DJ, Serruys PWJC, Berwanger O, Bacal F, Lemos PA; NEO-MINDSET Trial Investigators. Early Withdrawal of Aspirin after PCI in Acute Coronary Syndromes. N Engl J Med. 2025 Nov 27;393(21):2095-2106. doi: 10.1056/NEJMoa2507980. Epub 2025 Aug 31.

  PMID: 40888723 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Pedro A Lemos, MD

  Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2020
• First Posted: April 24, 2020
• Study Start: October 15, 2020
• Primary Completion: November 30, 2024
• Study Completion: December 30, 2024
• Last Updated: July 3, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (50)