Phase
Condition
Myocardial Ischemia
Cardiac Disease
Heart Disease
Treatment
Antiplatelet Monotherapy
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects must meet all the criteria below:
Age >=18 years;
Clinical presentation compatible with acute coronary syndrome with onset < 24 hoursbefore admission;
Successful percutaneous coronary intervention(s) of all target lesions (culprit andnon-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 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:
Acute coronary syndrome on index admission treated in a conservative way or byunsuccessful percutaneous intervention or surgically;
Presence of residual lesions which are likely to require future treatment in thenext 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, coronaryembolism, spontaneous coronary artery dissection, myocardial ischemia due tosupply/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 ofhepatitis 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 ofdrugs;
Subject with life expectation lower than 1 year;
Any significant medical condition that, in the investigator's opinion, couldinterfere with the ideal participation of the subject in the study;
Participation in other study in the past 12 months, unless a direct benefit to thesubject can be expected.
Impossibility of being treated with dual antiplatelet therapy for 12 months, basedon investigator judgement.
Study Design
Study Description
Connect with a study center
Acurácia Serviços Médicos
Rio Branco, Acre
BrazilSite Not Available
Hospital Ana Nery
Salvador, BA
BrazilSite Not Available
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
Fortaleza, CE
BrazilSite Not Available
Hospital de Base de Brasília
Brasília, DF
BrazilSite Not Available
Instituto Aramari APO
Brasília, DF
BrazilSite Not Available
Instituto Cardiovascular de Linhares
Linhares, ES
BrazilSite Not Available
Hospital Evangélico de Vila Velha
Vila Velha, ES
BrazilSite Not Available
Hospital Santa Casa de Misericórdia de Vitória
Vitória, ES
BrazilSite Not Available
Universidade Federal de Goiás
Goiânia, GO
BrazilSite Not Available
Hospital Felício Rocho
Belo Horizonte, MG
BrazilSite Not Available
Hospital Madre Teresa
Belo Horizonte, MG
BrazilSite Not Available
Hospital Universitário Ciências Médicas de Belo Horizonte
Belo Horizonte, MG
BrazilSite Not Available
Hospital Santa Lucia
Poços De Caldas, MG
BrazilSite Not Available
Hospital de Clínicas da Universidade Federal do Triângulo Mineiro
Uberaba, MG
BrazilSite Not Available
Hospital Universitário Maria Aparecida Pedrossian
Campo Grande, MS
BrazilSite Not Available
CASSEMS
Campo Grande, Mato Grosso Do Sul
BrazilSite Not Available
Instituto Orizonti
Belo Horizonte, Minas Gerais
BrazilSite Not Available
Eurolatino
Juiz De Fora, Minas Gerais
BrazilSite Not Available
Santa Casa da Misericórdia de Passos
Passos, Minas Gerais
BrazilSite Not Available
Hospital Real Português
Recife, PE
BrazilSite Not Available
Pontifícia Universidade Católica do Paraná
Curitiba, Paraná
BrazilSite Not Available
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
Recife, Pernambuco
BrazilSite Not Available
HUPE - Hospital Universitário Pedro Ernesto
Rio De Janeiro, RJ
BrazilSite Not Available
Hospital São Lucas
Rio De Janeiro, RJ
BrazilSite Not Available
Instituto Nacional de Cardiologia - INC
Rio De Janeiro, RJ
BrazilSite Not Available
Hospital São Lucas da PUCRS
Porto Alegre, RS
BrazilSite Not Available
Hospital de Clínicas de Porto Alegre
Porto Alegre, RS
BrazilSite Not Available
Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi
Porto Alegre, RS
BrazilSite Not Available
Instituto Atena de Pesquisa
Natal, Rio Grande Do Norte
BrazilSite Not Available
Hospital Baia Sul
Florianópolis, SC
BrazilSite Not Available
Hospital Instituto de Cardiologia de SC
Florianópolis, SC
BrazilSite Not Available
Centro de Pesquisa Clínica do Coração
Aracaju, SE
BrazilSite Not Available
Hospital Universitário São Francisco na Providência de Deus
Bragança Paulista, SP
BrazilSite Not Available
Instituição, Hospital e Maternidade Celso Pierro
Campinas, SP
BrazilSite Not Available
Irmandade da Santa Casa de Misericórdia de Marilia
Marilia, SP
BrazilSite Not Available
Santa Casa da Misericórdia de Santos
Santos, SP
BrazilSite Not Available
Hospital 9 de Julho
São Paulo, SP
BrazilSite Not Available
Hospital Dante Pazzanese
São Paulo, SP
BrazilSite Not Available
Instituto de Assistência Médica ao Servidor Público Estadual
São Paulo, SP
BrazilSite Not Available
Instituto do Coração - InCor
São Paulo, SP
BrazilSite Not Available
Real e Benemérita Associação Portuguesa de Beneficência
São Paulo, SP
BrazilSite Not Available
Santa Casa de São Paulo
São Paulo, SP
BrazilSite Not Available
UPECLIN
Botucatu, São Paulo
BrazilSite Not Available
Instituto De Pesquisa Clinica de Campinas
Campinas, São Paulo
BrazilSite Not Available
Hospital Regional de Presidente Prudente
Presidente Prudente, São Paulo
BrazilSite Not Available
Hospital de Base
São José Do Rio Preto, São Paulo
BrazilSite Not Available
Instituto Estadual de Cardiologia Aloysio de Castro
Rio De Janeiro,
BrazilSite Not Available
Hospital Israelita Albert Einstein
São Paulo, 05652- 900
BrazilSite Not Available
Hospital São Paulo - Unifesp
São Paulo,
BrazilSite Not Available
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