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

NCT ID: NCT04360720

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3410 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2024-12-30

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.

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.

Conditions

Acute Coronary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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)

Group Type: NO_INTERVENTION

No interventions assigned to this group

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)

Group Type: EXPERIMENTAL

Antiplatelet Monotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Monotherapy

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro A Lemos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Israelita Albert Einstein

Locations

Hospital de Messejana Dr. Carlos Alberto Studart Gomes

Fortaleza, Ceará, Brazil

Instituto Cardiovascular de Linhares

Linhares, Espírito Santo, Brazil

Hospital Evangélico de Vila Velha

Vila Velha, Espírito Santo, Brazil

Hospital Santa Casa de Misericórdia de Vitória

Vitória, Espírito Santo, Brazil

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Hospital de Base de Brasília

Brasília, Federal District, Brazil

Instituto Aramari APO

Brasília, Federal District, Brazil

Hospital Municipal Aparecida de Goiania

Goiânia, Goiás, Brazil

Universidade Federal de Goiás

Goiânia, Goiás, Brazil

CASSEMS

Campo Grande, Mato Grosso do Sul, Brazil

Hospital Universitário Maria Aparecida Pedrossian

Campo Grande, Mato Grosso do Sul, Brazil

Hospital Felício Rocho

Belo Horizonte, Minas Gerais, Brazil

Hospital Madre Teresa

Belo Horizonte, Minas Gerais, Brazil

Hospital Universitário Ciências Médicas de Belo Horizonte

Belo Horizonte, Minas Gerais, Brazil

Instituto Orizonti

Belo Horizonte, Minas Gerais, Brazil

Eurolatino

Juiz de Fora, Minas Gerais, Brazil

Santa Casa da Misericórdia de Passos

Passos, Minas Gerais, Brazil

Hospital Santa Lucia

Poços de Caldas, Minas Gerais, Brazil

Hospital de Clínicas da Universidade Federal do Triângulo Mineiro

Uberaba, Minas Gerais, Brazil

Pontifícia Universidade Católica do Paraná

Curitiba, Paraná, Brazil

Hospital Real Português

Recife, Pernambuco, Brazil

Instituto de Medicina Integral Professor Fernando Figueira - IMIP

Recife, Pernambuco, Brazil

Hospital São Lucas

Rio de Janeiro, Rio de Janeiro, Brazil

HUPE - Hospital Universitário Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Estadual de Cardiologia Aloysio de Castro

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Nacional de Cardiologia - INC

Rio de Janeiro, Rio de Janeiro, Brazil

Instituto Atena de Pesquisa

Natal, Rio Grande do Norte, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Baia Sul

Florianópolis, Santa Catarina, Brazil

Hospital Instituto de Cardiologia de SC

Florianópolis, Santa Catarina, Brazil

Centro de Pesquisa Clínica do Coração

Aracaju, Sergipe, Brazil

UPECLIN

Botucatu, São Paulo, Brazil

Hospital Universitário São Francisco na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Instituição, Hospital e Maternidade Celso Pierro

Campinas, São Paulo, Brazil

Instituto De Pesquisa Clinica de Campinas

Campinas, São Paulo, Brazil

UNICAMP

Campinas, São Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de Marilia

Marília, São Paulo, Brazil

Hospital Municipal Antonio Giglio

Osasco, São Paulo, Brazil

Hospital Regional de Presidente Prudente

Presidente Prudente, São Paulo, Brazil

Santa Casa da Misericórdia de Santos

Santos, São Paulo, Brazil

Hospital de Base

São José do Rio Preto, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Hospital 9 de Julho

São Paulo, São Paulo, Brazil

Hospital Dante Pazzanese

São Paulo, São Paulo, Brazil

Hospital São Paulo - Unifesp

São Paulo, São Paulo, Brazil

Instituto de Assistência Médica ao Servidor Público Estadual

São Paulo, São Paulo, Brazil

Instituto do Coração - InCor

São Paulo, São Paulo, Brazil

Real e Benemérita Associação Portuguesa de Beneficência

São Paulo, São Paulo, Brazil

Countries

Brazil

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Other Identifiers

3992

Identifier Type: -

Identifier Source: org_study_id