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PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial (NEOMINDSET)

Primary Purpose

Acute Coronary Syndrome

Status
Recruiting
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Antiplatelet Monotherapy
Sponsored by
Hospital Israelita Albert Einstein
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subjects must meet all the criteria below:

  1. Age >=18 years;
  2. Clinical presentation compatible with acute coronary syndrome with onset < 24 hours before 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 in a conservative way or by unsuccessful percutaneous intervention or surgically;
  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 cerebrovascular accident < 30 days;
  9. Presence of brain arteriovenous malformation;
  10. Index event of non-atherothrombotic etiology (i.e., stent thrombosis, 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 of 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 of the subject 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.

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

Arm Type

No Intervention

Experimental

Arm Label

Dual Antiplatelet Therapy

Antiplatelet Monotherapy

Arm Description

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)

Outcomes

Primary Outcome Measures

Composite endpoint of all-cause mortality, cerebrovascular accident, myocardial infarction or urgent target vessel revascularization.
Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
Bleeding Academic Research Consortium (BARC) type-2, -3 or -5 bleeding event
Co-Primary Safety Endpoint (superiority hypothesis)

Secondary Outcome Measures

Total of deaths, and cardiac and non-cardiac deaths
Total of deaths, and cardiac and non-cardiac deaths
Sudden death
Sudden death
Cerebrovascular accident
Cerebrovascular accident
Myocardial Infarction
Myocardial Infarction
Stent thrombosis
Stent thrombosis
Non-scheduled invasive coronary treatment
Non-scheduled invasive coronary treatment
BARC 1-5 type bleeding
BARC 1-5 type bleeding
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
Cost-effectiveness ratio
Cost-effectiveness ratio

Full Information

First Posted
April 22, 2020
Last Updated
February 15, 2023
Sponsor
Hospital Israelita Albert Einstein
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1. Study Identification

Unique Protocol Identification Number
NCT04360720
Brief Title
PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial
Acronym
NEOMINDSET
Official Title
PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial A Drug Reduction Study for Patients With Acute Coronary Syndrome in the Unified Health System in Brazil
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2020 (Actual)
Primary Completion Date
January 30, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Israelita Albert Einstein

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome
Keywords
Acute Coronary Syndrome, Antithrombotic Therapy, Dual Antiplatelet Therapy with acetylsalicylic acid, Monotherapy without acetylsalicylic acid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual Antiplatelet Therapy
Arm Type
No Intervention
Arm Description
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)
Arm Title
Antiplatelet Monotherapy
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Antiplatelet Monotherapy
Intervention Description
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 until the end of the study, at Month 12.
Primary Outcome Measure Information:
Title
Composite endpoint of all-cause mortality, cerebrovascular accident, myocardial infarction or urgent target vessel revascularization.
Description
Co-Primary Efficacy Endpoint (non-inferiority hypothesis)
Time Frame
12 months
Title
Bleeding Academic Research Consortium (BARC) type-2, -3 or -5 bleeding event
Description
Co-Primary Safety Endpoint (superiority hypothesis)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Total of deaths, and cardiac and non-cardiac deaths
Description
Total of deaths, and cardiac and non-cardiac deaths
Time Frame
12 months
Title
Sudden death
Description
Sudden death
Time Frame
30 days
Title
Cerebrovascular accident
Description
Cerebrovascular accident
Time Frame
12 months
Title
Myocardial Infarction
Description
Myocardial Infarction
Time Frame
12 months
Title
Stent thrombosis
Description
Stent thrombosis
Time Frame
12 months
Title
Non-scheduled invasive coronary treatment
Description
Non-scheduled invasive coronary treatment
Time Frame
12 months
Title
BARC 1-5 type bleeding
Description
BARC 1-5 type bleeding
Time Frame
12 months
Title
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
Description
Composite net adverse event (occurrence of co-primary efficacy endpoint or co-primary safety endpoint)
Time Frame
12 months
Title
Cost-effectiveness ratio
Description
Cost-effectiveness ratio
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pedro A Lemos, MD
Phone
+55 (11) 98317-5000
Email
pedro.lemos@einstein.br
First Name & Middle Initial & Last Name or Official Title & Degree
Marcelo Franken, MD
Phone
+55 (11) 99277-3509
Email
marcelo.franken@einstein.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pedro A Lemos, MD
Organizational Affiliation
Hospital Israelita Albert Einstein
Official's Role
Principal Investigator
Facility Information:
Facility Name
Acurácia Serviços Médicos
City
Rio Branco
State/Province
Acre
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Odilson Silvestre, MD, PhD
Facility Name
Hospital Ana Nery
City
Salvador
State/Province
BA
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristiano Guedes, MD, PhD
Facility Name
Hospital de Messejana Dr. Carlos Alberto Studart Gomes
City
Fortaleza
State/Province
CE
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Falcão, MD
Facility Name
Hospital de Base de Brasília
City
Brasília
State/Province
DF
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alberto Fonseca, MD
Facility Name
Instituto Aramari APO
City
Brasília
State/Province
DF
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandre Soares, MD
Facility Name
Instituto Cardiovascular de Linhares
City
Linhares
State/Province
ES
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
João Tinoco de Paula, MD
Facility Name
Hospital Evangélico de Vila Velha
City
Vila Velha
State/Province
ES
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Arruda, MD
Facility Name
Hospital Santa Casa de Misericórdia de Vitória
City
Vitória
State/Province
ES
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Serpa, MD
Facility Name
Universidade Federal de Goiás
City
Goiânia
State/Province
GO
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weimar Souza, MD, PhD
Facility Name
CASSEMS
City
Campo Grande
State/Province
Mato Grosso Do Sul
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria A Budib, MD
Facility Name
Hospital Felício Rocho
City
Belo Horizonte
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamil Saad, MD
Facility Name
Hospital Madre Teresa
City
Belo Horizonte
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos Marino, MD
Facility Name
Hospital Universitário Ciências Médicas de Belo Horizonte
City
Belo Horizonte
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Ramos, MD, PhD
Facility Name
Hospital Santa Lucia
City
Poços De Caldas
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ricardo Bergo, MD
Facility Name
Hospital de Clínicas da Universidade Federal do Triângulo Mineiro
City
Uberaba
State/Province
MG
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernando de Martino, MD
Facility Name
Instituto Orizonti
City
Belo Horizonte
State/Province
Minas Gerais
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Estevão Figueiredo, MD
Facility Name
Eurolatino
City
Juiz De Fora
State/Province
Minas Gerais
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gustavo Ramalho, MD
Facility Name
Santa Casa da Misericórdia de Passos
City
Passos
State/Province
Minas Gerais
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Walter Alvarenga, MD
Facility Name
Hospital Universitário Maria Aparecida Pedrossian
City
Campo Grande
State/Province
MS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Delcio Gonçalves, MD
Facility Name
Pontifícia Universidade Católica do Paraná
City
Curitiba
State/Province
Paraná
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José R Fortes
Facility Name
Instituto de Medicina Integral Professor Fernando Figueira - IMIP
City
Recife
State/Province
Pernambuco
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavio Oliveira, MD
Facility Name
Hospital Real Português
City
Recife
State/Province
PE
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Montenegro, MD
Facility Name
Instituto Atena de Pesquisa
City
Natal
State/Province
Rio Grande Do Norte
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
André Antonangelo, MD
Facility Name
Hospital São Lucas
City
Rio De Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno Paolino, MD, PhD
Facility Name
HUPE - Hospital Universitário Pedro Ernesto
City
Rio De Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esmeralci Ferreira, MD, PhD
Facility Name
Instituto Nacional de Cardiologia - INC
City
Rio De Janeiro
State/Province
RJ
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fernanda Sampaio, MD
Facility Name
Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Wainstein, MD, PhD
Facility Name
Hospital São Lucas da PUCRS
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulo Caramori, MD
Facility Name
Instituto de Cardiologia do RS - Fundação Universitária de Cardiologi
City
Porto Alegre
State/Province
RS
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rogério Sarmento Leite, MD, PhD
Facility Name
Hospital Baia Sul
City
Florianópolis
State/Province
SC
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Joaquim, MD
Facility Name
Hospital Instituto de Cardiologia de SC
City
Florianópolis
State/Province
SC
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rodrigo Joaquim, MD
Facility Name
Centro de Pesquisa Clínica do Coração
City
Aracaju
State/Province
SE
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Silveira, MD, PhD
Facility Name
Hospital Universitário São Francisco na Providência de Deus
City
Bragança Paulista
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Murillo Antunes, MD, PhD
Facility Name
Instituição, Hospital e Maternidade Celso Pierro
City
Campinas
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aloisio Rocha, MD, PhD
Facility Name
Irmandade da Santa Casa de Misericórdia de Marilia
City
Marilia
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro de Andrade, MD
Facility Name
Santa Casa da Misericórdia de Santos
City
Santos
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philipe Saccab, MD
Facility Name
Hospital 9 de Julho
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Lima, MD, PhD
Facility Name
Hospital Dante Pazzanese
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Ohe, MD
Facility Name
Instituto de Assistência Médica ao Servidor Público Estadual
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Ximenes, MD
Facility Name
Instituto do Coração - InCor
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Remo Furtado, MD, PhD
Facility Name
Real e Benemérita Associação Portuguesa de Beneficência
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José Mangione, MD, PhD
Facility Name
Santa Casa de São Paulo
City
São Paulo
State/Province
SP
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Alves, MD, PhD
Facility Name
UPECLIN
City
Botucatu
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marcos M Seki, MD
Facility Name
Instituto De Pesquisa Clinica de Campinas
City
Campinas
State/Province
São Paulo
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
José F Saraiva, MD, PhD
Facility Name
Hospital Regional de Presidente Prudente
City
Presidente Prudente
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charlene Nascimento, MD
Facility Name
Hospital de Base
City
São José Do Rio Preto
State/Province
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lilia Maia, MD, PhD
Facility Name
Instituto Estadual de Cardiologia Aloysio de Castro
City
Rio De Janeiro
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgard Quintella, MD
Facility Name
Hospital Israelita Albert Einstein
City
São Paulo
ZIP/Postal Code
05652- 900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pedro A Lemos, MD
Phone
+55 (11) 2151-0449
Email
pedro.lemos@einstein.br
First Name & Middle Initial & Last Name & Degree
Marcelo Franken, MD
Facility Name
Hospital São Paulo - Unifesp
City
São Paulo
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriano Caixeta, MD, PhD

12. IPD Sharing Statement

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PercutaNEOus Coronary Intervention Followed by Monotherapy INstead of Dual Antiplatelet Therapy in the SETting of Acute Coronary Syndromes: The NEO-MINDSET Trial

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