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Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
Sponsor: Hospital Israelita Albert Einstein
Summary
Elevated blood pressure (BP) consists of a major public health concern especially in low and middle income countries. Besides being a highly prevalent condition, it is also a risk factor for several major cardiovascular events including stroke (which consists of the second leading cause of death in developing countries) and coronary artery disease, and is also related to cognitive decline. The OPTIMAL Stroke trial consists of a two-arm, multicenter, randomized clinical trial designed to test whether a lower target systolic blood pressure (SBP) as compared to the currently recommended target for stroke patients will reduce the occurrence of major cardiovascular events.
Official title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
4368
Start Date
2019-08-05
Completion Date
2026-07-08
Last Updated
2026-08-13
Healthy Volunteers
No
Interventions
Intensive Control of Systolic Blood Pressure (SBP)
Participants in the Intensive arm have a goal of SBP \<120 mm Hg. The use of angiotensin converting enzyme (ACE)-inhibitors/Angiotension receptor blockers (ARBs), Thiazide-type diuretics, calcium channel blockers (CCB), Sustained-release calcium channel blockers (CCBs) will be encouraged, preferably fixed-dose combinations of indapamide + perindopril arginine, perindopril arginine + amlodipine or indapamide + perindopril arginine +amlodipine
Standard control of Systolic Blood Pressure (SBP)
The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Locations (30)
Clínica Silvestre Santé
Rio Branco, Acre, Brazil
Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
Maceió, Alagoas, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, Botucatu, Brazil
Hospital Geral de Fortaleza
Fortaleza, Ceará, Brazil
Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
Fortaleza, Ceará, Brazil
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, Brazil
Hospital Ana Nery
Salvador, Estado de Bahia, Brazil
Instituto Hospitalar de Base Do Distrito Federal
Brasília, Federal District, Brazil
Universidade Federal de Goias
Goiânia, Goiás, Brazil
Hospital Universitário Maria Aparecida Pedrossian - UFMS
Campo Grande, Mato Grosso do Sul, Brazil
Flumignano Instituto de Medicina
Curitiba, Paraná, Brazil
PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
Recife, Pernambuco, Brazil
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital Moinho de Ventos
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Governador Celso Ramos
Florianópolis, Santa Catarina, Brazil
Clínica Neurológica e Neurocirurgica de Joinville LTDA
Joinville, Santa Catarina, Brazil
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
Joinville, Santa Catarina, Brazil
Hospital Univ. São Francisco de Assis na Providencia de Deus
Bragança Paulista, São Paulo, Brazil
Universidade Estadual de Campinas - Hospital de Clínicas
Campinas, São Paulo, Brazil
Hospital Carlos Fernando Malzoni
Matão, São Paulo, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Ribeirão Preto, São Paulo, Brazil
Clínica Vilela e Martin
São José do Rio Preto, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, Brazil
Hospital São Paulo
São Paulo, São Paulo, Brazil
InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
São Paulo, São Paulo, Brazil