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

Last updated: April 4, 2025
Sponsor: Hospital Israelita Albert Einstein
Overall Status: Active - Not Recruiting

Phase

3

Condition

Myocardial Ischemia

Cardiac Disease

Heart Disease

Treatment

Antiplatelet Monotherapy

Clinical Study ID

NCT04360720
3992
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Subjects must meet all the criteria below:

  1. Age >=18 years;

  2. Clinical presentation compatible with acute coronary syndrome with onset < 24 hoursbefore admission;

  3. Successful percutaneous coronary intervention(s) of all target lesions (culprit andnon-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 andgive an informed consent in writing using a form approved in advance by the localEthics Committee.

Exclusion

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 byunsuccessful percutaneous intervention or surgically;

  2. Presence of residual lesions which are likely to require future treatment in thenext 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, coronaryembolism, spontaneous coronary artery dissection, myocardial ischemia due tosupply/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 ofhepatitis 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 ofdrugs;

  17. Subject with life expectation lower than 1 year;

  18. Any significant medical condition that, in the investigator's opinion, couldinterfere 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 thesubject can be expected.

  20. Impossibility of being treated with dual antiplatelet therapy for 12 months, basedon investigator judgement.

Study Design

Total Participants: 3400
Treatment Group(s): 1
Primary Treatment: Antiplatelet Monotherapy
Phase: 3
Study Start date:
October 15, 2020
Estimated Completion Date:
June 30, 2025

Study 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.

Connect with a study center

  • Acurácia Serviços Médicos

    Rio Branco, Acre
    Brazil

    Site Not Available

  • Hospital Ana Nery

    Salvador, BA
    Brazil

    Site Not Available

  • Hospital de Messejana Dr. Carlos Alberto Studart Gomes

    Fortaleza, CE
    Brazil

    Site Not Available

  • Hospital de Base de Brasília

    Brasília, DF
    Brazil

    Site Not Available

  • Instituto Aramari APO

    Brasília, DF
    Brazil

    Site Not Available

  • Instituto Cardiovascular de Linhares

    Linhares, ES
    Brazil

    Site Not Available

  • Hospital Evangélico de Vila Velha

    Vila Velha, ES
    Brazil

    Site Not Available

  • Hospital Santa Casa de Misericórdia de Vitória

    Vitória, ES
    Brazil

    Site Not Available

  • Universidade Federal de Goiás

    Goiânia, GO
    Brazil

    Site Not Available

  • Hospital Felício Rocho

    Belo Horizonte, MG
    Brazil

    Site Not Available

  • Hospital Madre Teresa

    Belo Horizonte, MG
    Brazil

    Site Not Available

  • Hospital Universitário Ciências Médicas de Belo Horizonte

    Belo Horizonte, MG
    Brazil

    Site Not Available

  • Hospital Santa Lucia

    Poços De Caldas, MG
    Brazil

    Site Not Available

  • Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

    Uberaba, MG
    Brazil

    Site Not Available

  • Hospital Universitário Maria Aparecida Pedrossian

    Campo Grande, MS
    Brazil

    Site Not Available

  • CASSEMS

    Campo Grande, Mato Grosso Do Sul
    Brazil

    Site Not Available

  • Instituto Orizonti

    Belo Horizonte, Minas Gerais
    Brazil

    Site Not Available

  • Eurolatino

    Juiz De Fora, Minas Gerais
    Brazil

    Site Not Available

  • Santa Casa da Misericórdia de Passos

    Passos, Minas Gerais
    Brazil

    Site Not Available

  • Hospital Real Português

    Recife, PE
    Brazil

    Site Not Available

  • Pontifícia Universidade Católica do Paraná

    Curitiba, Paraná
    Brazil

    Site Not Available

  • Instituto de Medicina Integral Professor Fernando Figueira - IMIP

    Recife, Pernambuco
    Brazil

    Site Not Available

  • HUPE - Hospital Universitário Pedro Ernesto

    Rio De Janeiro, RJ
    Brazil

    Site Not Available

  • Hospital São Lucas

    Rio De Janeiro, RJ
    Brazil

    Site Not Available

  • Instituto Nacional de Cardiologia - INC

    Rio De Janeiro, RJ
    Brazil

    Site Not Available

  • Hospital São Lucas da PUCRS

    Porto Alegre, RS
    Brazil

    Site Not Available

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, RS
    Brazil

    Site Not Available

  • Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi

    Porto Alegre, RS
    Brazil

    Site Not Available

  • Instituto Atena de Pesquisa

    Natal, Rio Grande Do Norte
    Brazil

    Site Not Available

  • Hospital Baia Sul

    Florianópolis, SC
    Brazil

    Site Not Available

  • Hospital Instituto de Cardiologia de SC

    Florianópolis, SC
    Brazil

    Site Not Available

  • Centro de Pesquisa Clínica do Coração

    Aracaju, SE
    Brazil

    Site Not Available

  • Hospital Universitário São Francisco na Providência de Deus

    Bragança Paulista, SP
    Brazil

    Site Not Available

  • Instituição, Hospital e Maternidade Celso Pierro

    Campinas, SP
    Brazil

    Site Not Available

  • Irmandade da Santa Casa de Misericórdia de Marilia

    Marilia, SP
    Brazil

    Site Not Available

  • Santa Casa da Misericórdia de Santos

    Santos, SP
    Brazil

    Site Not Available

  • Hospital 9 de Julho

    São Paulo, SP
    Brazil

    Site Not Available

  • Hospital Dante Pazzanese

    São Paulo, SP
    Brazil

    Site Not Available

  • Instituto de Assistência Médica ao Servidor Público Estadual

    São Paulo, SP
    Brazil

    Site Not Available

  • Instituto do Coração - InCor

    São Paulo, SP
    Brazil

    Site Not Available

  • Real e Benemérita Associação Portuguesa de Beneficência

    São Paulo, SP
    Brazil

    Site Not Available

  • Santa Casa de São Paulo

    São Paulo, SP
    Brazil

    Site Not Available

  • UPECLIN

    Botucatu, São Paulo
    Brazil

    Site Not Available

  • Instituto De Pesquisa Clinica de Campinas

    Campinas, São Paulo
    Brazil

    Site Not Available

  • Hospital Regional de Presidente Prudente

    Presidente Prudente, São Paulo
    Brazil

    Site Not Available

  • Hospital de Base

    São José Do Rio Preto, São Paulo
    Brazil

    Site Not Available

  • Instituto Estadual de Cardiologia Aloysio de Castro

    Rio De Janeiro,
    Brazil

    Site Not Available

  • Hospital Israelita Albert Einstein

    São Paulo, 05652- 900
    Brazil

    Site Not Available

  • Hospital São Paulo - Unifesp

    São Paulo,
    Brazil

    Site Not Available

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