Can pushing blood pressure lower save stroke Survivors' hearts?
NCT ID NCT04036409
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 2 times
Summary
This study tests whether a very low blood pressure target (below 120 mmHg) can prevent major heart problems in people who have had a stroke or mini-stroke. About 4,300 participants are randomly assigned to either intensive or standard blood pressure control and followed for about 3.5 years. The goal is to see if the lower target reduces the risk of heart attack, stroke, or death from heart disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- intensive blood pressure control (targeting systolic BP <120 mmHg using standard antihypertensive drugs)
- What this could lead to
- If successful, this could show that a lower blood pressure target after a stroke significantly reduces the risk of heart attacks, further strokes, and other major cardiovascular events.
- What could go wrong
- This is a large trial, but it is still testing a target, not a new drug. The intensive target may not be safe or tolerable for all patients, and results may not apply to everyone with a stroke.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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4,368 people
The number who actually took part.
- Started
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Aug 2019
- Finished
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Jul 2026
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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. * Secondary hypertension. * Class IV Canadian Cardiovascular Society (CCS) Resting Angina. * Acute coronary syndrome in the last six months * Severe renal dysfunction with GFR \< 20 mL/min/1.73m2 calculated by the CKD-EPI equation * Refusal to consent. * Symptomatic heart failure - Class IV New York Heart Association (NYHA) or ejection fraction \<35% on Doppler echocardiography. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
Joinville, Santa Catarina, Brazil
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Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
Maceió, Alagoas, Brazil
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Clínica Neurológica e Neurocirurgica de Joinville LTDA
Joinville, Santa Catarina, 89202-165, Brazil
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Clínica Silvestre Santé
Rio Branco, Acre, Brazil
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Clínica Vilela e Martin
São José do Rio Preto, São Paulo, 15090-365, Brazil
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Flumignano Instituto de Medicina
Curitiba, Paraná, 82590-300, Brazil
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Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 150900000, Brazil
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Hospital Ana Nery
Salvador, Estado de Bahia, 40323-010, Brazil
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Hospital Carlos Fernando Malzoni
Matão, São Paulo, 15990-060, Brazil
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Hospital Geral de Fortaleza
Fortaleza, Ceará, 60175-295, Brazil
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Hospital Governador Celso Ramos
Florianópolis, Santa Catarina, 88015-270, Brazil
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Hospital Moinho de Ventos
Porto Alegre, Rio Grande do Sul, 90035-000, Brazil
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Hospital São Paulo
São Paulo, São Paulo, 04037-002, Brazil
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Hospital Univ. São Francisco de Assis na Providencia de Deus
Bragança Paulista, São Paulo, 12916-542, Brazil
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Hospital Universitário Maria Aparecida Pedrossian - UFMS
Campo Grande, Mato Grosso do Sul, 79080-190, Brazil
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Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
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Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, 40110-060, Brazil
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Hospital das Clínicas da FMUSP
São Paulo, São Paulo, (11) 2661-0000, Brazil
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Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Ribeirão Preto, São Paulo, 14015-010, Brazil
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-007, Brazil
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Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
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InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
São Paulo, São Paulo, 05403-900, Brazil
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Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909, Brazil
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Instituto Hospitalar de Base Do Distrito Federal
Brasília, Federal District, 70335900, Brazil
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Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020, Brazil
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PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
Recife, Pernambuco, 74970-240, Brazil
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UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, Botucatu, 18618-686, Brazil
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Universidade Estadual de Campinas - Hospital de Clínicas
Campinas, São Paulo, 13083-888, Brazil
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Universidade Federal de Goias
Goiânia, Goiás, 74690-900, Brazil
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Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-372, Brazil
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