Can pushing blood pressure lower save stroke Survivors' hearts?

NCT ID NCT04036409

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

4,368 people

The number who actually took part.

Started

Aug 2019

Finished

Jul 2026

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Blood pressure are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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

  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda

    Joinville, Santa Catarina, Brazil

  • Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)

    Maceió, Alagoas, Brazil

  • Clínica Neurológica e Neurocirurgica de Joinville LTDA

    Joinville, Santa Catarina, 89202-165, Brazil

  • Clínica Silvestre Santé

    Rio Branco, Acre, Brazil

  • Clínica Vilela e Martin

    São José do Rio Preto, São Paulo, 15090-365, Brazil

  • Flumignano Instituto de Medicina

    Curitiba, Paraná, 82590-300, Brazil

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 150900000, Brazil

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 40323-010, Brazil

  • Hospital Carlos Fernando Malzoni

    Matão, São Paulo, 15990-060, Brazil

  • Hospital Geral de Fortaleza

    Fortaleza, Ceará, 60175-295, Brazil

  • Hospital Governador Celso Ramos

    Florianópolis, Santa Catarina, 88015-270, Brazil

  • Hospital Moinho de Ventos

    Porto Alegre, Rio Grande do Sul, 90035-000, Brazil

  • Hospital São Paulo

    São Paulo, São Paulo, 04037-002, Brazil

  • Hospital Univ. São Francisco de Assis na Providencia de Deus

    Bragança Paulista, São Paulo, 12916-542, Brazil

  • Hospital Universitário Maria Aparecida Pedrossian - UFMS

    Campo Grande, Mato Grosso do Sul, 79080-190, Brazil

  • Hospital Universitário Pedro Ernesto - UERJ

    Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

  • Hospital Universitário Professor Edgard Santos

    Salvador, Estado de Bahia, 40110-060, Brazil

  • Hospital das Clínicas da FMUSP

    São Paulo, São Paulo, (11) 2661-0000, Brazil

  • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo

    Ribeirão Preto, São Paulo, 14015-010, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-007, Brazil

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

    São Paulo, São Paulo, 05403-900, Brazil

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo, 04012-909, Brazil

  • Instituto Hospitalar de Base Do Distrito Federal

    Brasília, Federal District, 70335900, Brazil

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, São Paulo, 01221-020, Brazil

  • PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares

    Recife, Pernambuco, 74970-240, Brazil

  • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP

    Botucatu, Botucatu, 18618-686, Brazil

  • Universidade Estadual de Campinas - Hospital de Clínicas

    Campinas, São Paulo, 13083-888, Brazil

  • Universidade Federal de Goias

    Goiânia, Goiás, 74690-900, Brazil

  • Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

    Fortaleza, Ceará, 60430-372, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.