PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial (NEOMINDSET)
Acute Coronary Syndrome
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Antithrombotic Therapy, Dual Antiplatelet Therapy with acetylsalicylic acid, Monotherapy without acetylsalicylic acid
Eligibility Criteria
Inclusion Criteria:
Subjects must meet all the criteria below:
- Age >=18 years;
- Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before 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.
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
- Acute coronary syndrome on index admission treated in a conservative way or by unsuccessful percutaneous intervention or surgically;
- 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 cerebrovascular accident < 30 days;
- Presence of brain arteriovenous malformation;
- Index event of non-atherothrombotic etiology (i.e., stent thrombosis, 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);
- Receiver of heart transplant;
- Known allergies or intolerance of acetylsalicylic acid, clopidogrel, ticlopidine, ticagrelor, prasugrel, heparin or antiproliferative agents from the limus-family of drugs;
- Subject with life expectation lower than 1 year;
- Any significant medical condition that, in the investigator's opinion, could interfere with the ideal participation of the subject in the study;
- Participation in other study in the past 12 months, unless a direct benefit to the subject can be expected.
- Impossibility of being treated with dual antiplatelet therapy for 12 months, based on investigator judgement.
Sites / Locations
- Acurácia Serviços Médicos
- Hospital Ana NeryRecruiting
- Hospital de Messejana Dr. Carlos Alberto Studart GomesRecruiting
- Hospital de Base de BrasíliaRecruiting
- Instituto Aramari APORecruiting
- Instituto Cardiovascular de LinharesRecruiting
- Hospital Evangélico de Vila VelhaRecruiting
- Hospital Santa Casa de Misericórdia de VitóriaRecruiting
- Universidade Federal de GoiásRecruiting
- CASSEMS
- Hospital Felício RochoRecruiting
- Hospital Madre TeresaRecruiting
- Hospital Universitário Ciências Médicas de Belo HorizonteRecruiting
- Hospital Santa LuciaRecruiting
- Hospital de Clínicas da Universidade Federal do Triângulo MineiroRecruiting
- Instituto OrizontiRecruiting
- EurolatinoRecruiting
- Santa Casa da Misericórdia de Passos
- Hospital Universitário Maria Aparecida PedrossianRecruiting
- Pontifícia Universidade Católica do ParanáRecruiting
- Instituto de Medicina Integral Professor Fernando Figueira - IMIPRecruiting
- Hospital Real PortuguêsRecruiting
- Instituto Atena de PesquisaRecruiting
- Hospital São LucasRecruiting
- HUPE - Hospital Universitário Pedro ErnestoRecruiting
- Instituto Nacional de Cardiologia - INCRecruiting
- Hospital de Clínicas de Porto AlegreRecruiting
- Hospital São Lucas da PUCRSRecruiting
- Instituto de Cardiologia do RS - Fundação Universitária de CardiologiRecruiting
- Hospital Baia SulRecruiting
- Hospital Instituto de Cardiologia de SCRecruiting
- Centro de Pesquisa Clínica do CoraçãoRecruiting
- Hospital Universitário São Francisco na Providência de DeusRecruiting
- Instituição, Hospital e Maternidade Celso PierroRecruiting
- Irmandade da Santa Casa de Misericórdia de MariliaRecruiting
- Santa Casa da Misericórdia de SantosRecruiting
- Hospital 9 de JulhoRecruiting
- Hospital Dante PazzaneseRecruiting
- Instituto de Assistência Médica ao Servidor Público EstadualRecruiting
- Instituto do Coração - InCorRecruiting
- Real e Benemérita Associação Portuguesa de BeneficênciaRecruiting
- Santa Casa de São PauloRecruiting
- UPECLIN
- Instituto De Pesquisa Clinica de Campinas
- Hospital Regional de Presidente PrudenteRecruiting
- Hospital de BaseRecruiting
- Instituto Estadual de Cardiologia Aloysio de CastroRecruiting
- Hospital Israelita Albert EinsteinRecruiting
- Hospital São Paulo - UnifespRecruiting
Arms of the Study
Arm 1
Arm 2
No Intervention
Experimental
Dual Antiplatelet Therapy
Antiplatelet Monotherapy
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)
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)