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NCT04036409Completed

Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients

A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients

Source: ClinicalTrials.gov · Last updated 13 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
4368 (actual)
First submitted
26 Jul 2019
Start date
5 Aug 2019
Primary completion date
8 Jul 2026
Lead sponsor
Hospital Israelita Albert Einstein
Diseases
Stroke
NCT number
NCT04036409

What you commit to

  • Study type: Interventional
  • Participants enrolled: 4368
  • From 5 Aug 2019 to the primary completion date, 8 Jul 2026
  • 29 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Conditions that, at the investigators' discretion, limit the patient's participation in the study, including but not limited to the following:
    • Recent history of alcohol and illicit drug abuse.
    • Psychiatric comorbidities (severe depression, schizophrenia, psychosis, etc.).
    • History of poor drug adherence and no attendance at consultations.
    • Planning to change of address in the next four years.
    • Planning to be absent from home city for more than three months in the next year.
    • Residing in the same residence of another patient previously included in this study.

Other illness

  • Secondary hypertension.
  • Class IV Canadian Cardiovascular Society (CCS) Resting Angina.
  • Acute coronary syndrome in the last six months

Lab values

  • Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation
  • Symptomatic heart failure - Class IV New York Heart Association (NYHA) or ejection fraction \<35% on Doppler echocardiography.

Other

  • Severe disability after the event that qualified the patient for the study, defined as a modified Rankin (mRankin) scale equal to or greater than 4.
  • Being part of another clinical trial involving interventions for cardiovascular prevention.
  • Body mass index \> 45 kg/m2.
  • Pregnancy or Breastfeeding.
  • Refusal to consent.

Who the study is looking for

  • History of ischemic stroke or transient ischemic attack (TIA), considered clinically stable in the 48 hours prior to inclusion in the study. (they will be classified into a recent stroke \<120 days or chronic when\> 120 days), AND
  • Systolic Blood Pressure (SBP) between 130 and 180 mmHg:
    • 130 -180 and use of up to one antihypertensive drug;
    • 130-170 and use of up to two drugs;
    • 130-160 and use of up to three drugs;
    • 130-150 and use of up to four drugs. AND

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (29)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Coordinator of this site? Confirm its status
BotucatuBrazilUnknown status
Hospital Univ. São Francisco de Assis na Providencia de Deus
Coordinator of this site? Confirm its status
Bragança PaulistaBrazilUnknown status
Instituto Hospitalar de Base Do Distrito Federal
Coordinator of this site? Confirm its status
BrasíliaBrazilUnknown status
Universidade Estadual de Campinas - Hospital de Clínicas
Coordinator of this site? Confirm its status
CampinasBrazilUnknown status
Hospital Universitário Maria Aparecida Pedrossian - UFMS
Coordinator of this site? Confirm its status
Campo GrandeBrazilUnknown status
Flumignano Instituto de Medicina
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CuritibaBrazilUnknown status
Hospital Governador Celso Ramos
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FlorianópolisBrazilUnknown status
Hospital Geral de Fortaleza
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FortalezaBrazilUnknown status
Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
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FortalezaBrazilUnknown status
Universidade Federal de Goias
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GoiâniaBrazilUnknown status
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
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JoinvilleBrazilUnknown status
Clinica Neurologica e Neurocirurgica de Joinville Ltda
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JoinvilleBrazilUnknown status
Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
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MaceióBrazilUnknown status
Hospital Carlos Fernando Malzoni
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MatãoBrazilUnknown status
Hospital Moinho de Ventos
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Porto AlegreBrazilUnknown status
Hospital de Clinicas de Porto Alegre
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Porto AlegreBrazilUnknown status
PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
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RecifeBrazilUnknown status
Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo
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Ribeirão PretoBrazilUnknown status
Clínica Silvestre Sante
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Rio BrancoBrazilUnknown status
Hospital Universitario Pedro Ernesto - UERJ
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Rio de JaneiroBrazilUnknown status
Hospital Universitário Professor Edgard Santos
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SalvadorBrazilUnknown status
Hospital Ana Nery
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SalvadorBrazilUnknown status
Clínica Vilela e Martin
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São José do Rio PretoBrazilUnknown status
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
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São José do Rio PretoBrazilUnknown status
Hospital das Clínicas da FMUSP
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São PauloBrazilUnknown status
Instituto Dante Pazzanese de Cardiologia
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São PauloBrazilUnknown status
Irmandade da Santa Casa de Misericórdia de São Paulo
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São PauloBrazilUnknown status
Hospital Sao Paulo
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São PauloBrazilUnknown status
InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.