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Clinical Trial Details

Trial ID: L4188
Source ID: NCT04040634
Associated Drug: Intensive Control Of Systolic Blood Pressure (Sbp)
Title: Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Patients With DIABETES Mellitus (OPTIMAL-DIABETES)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Diabetes Mellitus|High Blood Pressure|Cardiovascular Diseases|Cognitive Impairment
Interventions: DRUG: Intensive Control of Systolic Blood Pressure (SBP)|DRUG: Standard control of Systolic Blood Pressure (SBP)
Outcome Measures: Primary: Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure, Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure, From randomization; for approximately a median of 3.5 years | Secondary: Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke, Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke, From randomization; for approximately a median of 3.5 years|Time to total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure, Time to first event of total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure, From randomization; for approximately a median of 3.5 years|Time to Death, Time to all cause death, From randomization; for approximately a median of 3.5 years|Time to Cardiovascular Death, Time to death from cardiovascular causes, From randomization; for approximately a median of 3.5 years|Time to Renal Death, Time to death from renal causes, From randomization; for approximately a median of 3.5 years|Time to Myocardial Infarction (MI), Time to myocardial infarction (MI), From randomization; for approximately a median of 3.5 years|Time to Stroke, Time to stroke, From randomization; for approximately a median of 3.5 years|Time to Ischemic Stroke, Time to ischemic stroke, From randomization; for approximately a median of 3.5 years|Time to Hemorrhagic Stroke, Time to hemorrhagic stroke, From randomization; for approximately a median of 3.5 years|Time to Undetermined type of Stroke, Time to Undetermined type of Stroke, From randomization; for approximately a median of 3.5 years|Time to Transient Ischemic Attack (TIA), Time to transient ischemic attack (TIA), From randomization; for approximately a median of 3.5 years|Time to Hospitalization for Unstable Angina, Time to Hospitalization for unstable angina, From randomization; for approximately a median of 3.5 years|Time to Hospitalization for Heart Failure, Time to hospitalization for heart failure, From randomization; for approximately a median of 3.5 years|Time to Renal Outcome, Time to Renal Outcome, defined as a 50% reduction in the glomerular filtration rate (GRF) associated with a final GFR of \< 60 mL/min/1.73m2 in patients without chronic kidney disease (GFR 60-90 mL/min/1.73m2) at baseline. In those patients with chronic kidney disease (\<60 mL/min/1.73m2) at baseline, the renal outcome will be defined as a 50% reduction in GFR or progression of renal disease to stage IV, requiring dialysis or kidney transplantation., From randomization; for approximately a median of 3.5 years|Time to Mild Cognitive Impairment, Time to Mild Cognitive Impairment, From randomization; for approximately a median of 3.5 years|Time to Mild Cognitive Impairment or All-Cause Probable Dementia, Time to mild cognitive impairment or all-cause probable dementia, From randomization; for approximately a median of 3.5 years|Time to All-Cause Probable Dementia, Time to all-cause probable dementia, From randomization; for approximately a median of 3.5 years
Sponsor/Collaborators: Sponsor: Hospital Israelita Albert Einstein | Collaborators: Ministry of Health, Brazil
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 9479
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2019-08-08
Completion Date: 2025-12-31
Results First Posted:
Last Update Posted: 2024-01-03
Locations: Centro de Pesquisas Clínicas Dr Marco Mota, Maceió, Alagoas, 57051-160, Brazil|Centro de Pesquisas em Diabetes e Doenças Endocrino-Metabólicas, Fortaleza, Bahia, 60430-350, Brazil|Hospital Ana Nery, Salvador, Bahia, 40323-010, Brazil|Instituto de Estudos E Pesquisas Clinicas Do Ceara, Fortaleza, Ceará, Brazil|Instituto Hospital de Base, Brasília, Distrito Federal, 70330-150, Brazil|Hospital Universitário Cassiano Antonio de Moraes, Vitória, Espirito Santo, 29043-260, Brazil|Universidade Federal de Goiás, Goiânia, Goiás, 74605-020, Brazil|NS Clínica de Diabetes e Endocrinologia Ltda, Goiânia, Goiás, 90020-090, Brazil|Hospital das Clinicas da Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais, 30130-100, Brazil|Centro de Pesquisa do Hospital Santa Lúcia, Poços De Caldas, Minas Gerais, 37710-005, Brazil|Medicina Nuclear Alto da XV, Curitiba, Paraná, Brazil|Hospital Universitário João de Barros Barreto - UFPA, Belém, Pará, Brazil|Pronto Socorro Cardiológico de Pernambuco Prof. Luiz Tavares da Silva, Recife, Pernambuco, 50100-060, Brazil|Hospital de Clínicas de Porto Alegre, Porto Alegre, Rio Grande Do Sul, 90035-903, Brazil|Hospital São Lucas da PUCRS, Porto Alegre, Rio Grande Do Sul, 90610-000, Brazil|Centro de Pesquisa Clínica do Coração, Aracaju, Sergipe, 49055-530, Brazil|Centro de Endocrinologia Geloneze, Campinas, São Paulo, 13073-350, Brazil|Universidade Estadual de Campinas - UNICAMP, Campinas, São Paulo, Brazil|Indacor Servicos Medicos Ltda, Indaiatuba, São Paulo, Brazil|Hospital das Clinicas da Faculdade de Medicina de Ribeirão Preto da Universidade de São Paulo, Ribeirão Preto, São Paulo, 14048-900, Brazil|Centro Integrado de Pesquisas, São José Do Rio Preto, São Paulo, 15090-000, Brazil|Clínica Vilela & Martin, São José Do Rio Preto, São Paulo, 15090-365, Brazil|Instituto de Cardiologia e Endocrinologia Rio Preto Ltda, São José Do Rio Preto, São Paulo, 15091-330, Brazil|Clínica Cardiológica, Votuporanga, São Paulo, 15505-189, Brazil|Santa Casa de Misericordia de Votuporanga, Votuporanga, São Paulo, Brazil|Faculdade de Ciências Médicas - Universidade do Estado do Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil|Clínica de Metabologia e Hipertensão da Universidade Federal de São Paulo, São Paulo, 04025-010, Brazil|Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, 05403-000, Brazil|Instituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, 05403-000, Brazil|Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil|Irmandade Da Santa Casa de Misericordia de Sao Paulo, São Paulo, Brazil|Real e Benemérita Associação Portuguesa de Beneficência/SP, São Paulo, Brazil
URL: https://clinicaltrials.gov/show/NCT04040634