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Ischemic StrokeOPTIMAL StrokeNCT04036409

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

A study of Ischemic Stroke and Blood Pressure, run by Hospital Israelita Albert Einstein at 30 sites in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,368 participants
Where
30 sitesBrazil
Study dates
5 Aug 2019to 8 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 17Show fewer
  • 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.

Trial locations and contacts

30 sites in 1 country.

30 sites in 1 country

Brazil30 sites

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

    Botucatu, Botucatu, 18618-686

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

    Bragança Paulista, São Paulo, 12916-542

  • Instituto Hospitalar de Base Do Distrito Federal

    Brasília, Federal District, 70335900

  • Universidade Estadual de Campinas - Hospital de Clínicas

    Campinas, São Paulo, 13083-888

  • Hospital Universitário Maria Aparecida Pedrossian - UFMS

    Campo Grande, Mato Grosso do Sul, 79080-190

  • Flumignano Instituto de Medicina

    Curitiba, Paraná, 82590-300

  • Hospital Governador Celso Ramos

    Florianópolis, Santa Catarina, 88015-270

  • Hospital Geral de Fortaleza

    Fortaleza, Ceará, 60175-295

  • Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

    Fortaleza, Ceará, 60430-372

  • Universidade Federal de Goias

    Goiânia, Goiás, 74690-900

  • Clínica Neurológica e Neurocirurgica de Joinville LTDA

    Joinville, Santa Catarina, 89202-165

  • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda

    Joinville, Santa Catarina

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

    Maceió, Alagoas

  • Hospital Carlos Fernando Malzoni

    Matão, São Paulo, 15990-060

  • Hospital Moinho de Ventos

    Porto Alegre, Rio Grande do Sul, 90035-000

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-007

  • Hospital de Clínicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

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

    Recife, Pernambuco, 74970-240

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

    Ribeirão Preto, São Paulo, 14015-010

  • Clínica Silvestre Santé

    Rio Branco, Acre

  • Hospital Universitário Pedro Ernesto - UERJ

    Rio de Janeiro, Rio de Janeiro, 20551-030

  • Hospital Universitário Professor Edgard Santos

    Salvador, Estado de Bahia, 40110-060

  • Hospital Ana Nery

    Salvador, Estado de Bahia, 40323-010

  • Clínica Vilela e Martin

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

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

    São José do Rio Preto, São Paulo, 150900000

  • Hospital das Clínicas da FMUSP

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

  • Irmandade da Santa Casa de Misericórdia de São Paulo

    São Paulo, São Paulo, 01221-020

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, São Paulo, 04012-909

  • Hospital São Paulo

    São Paulo, São Paulo, 04037-002

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

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

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

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.

Being tested
Intensive Control of Systolic Blood Pressure (SBP), Standard control of Systolic Blood Pressure (SBP)
Medical subject headings
Ischemic Stroke, Cognitive Dysfunction, Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Intensive Control of Systolic Blood Pressure (SBP)Drug

    Also called Intensive BP control targeting SBP <120 mmHg.

    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)Drug

    Also called Standard control of SBP targeting SBP < 140 mmHg

    The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Study groups in NCT04036409
Study groupRoleWhat they receive
Intensive Control of Systolic Blood Pressure (SBP)ExperimentalParticipants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg.
Receives: Drug: Intensive Control of Systolic Blood Pressure (SBP)
Standard Control of Systolic Blood PressureActive comparatorParticipants randomized into the Standard arm will have a goal of SBP <140 mm Hg
Receives: Drug: Standard control of Systolic Blood Pressure (SBP)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a mean of 3.5 years ]

    Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure

    Measured: From randomization; for approximately a mean of 3.5 years

Secondary outcomes (18)

  1. Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke [ Time Frame: From randomization; for approximately a mean of 3.5 years ]

    Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke

    Measured: From randomization; for approximately a mean of 3.5 years

  2. Time to total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a mean of 3.5 years ]

    Time to first event of total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure

    Measured: From randomization; for approximately a mean of 3.5 years

  3. Time to Death

    Time to all cause death

    Measured: From randomization; for approximately a mean of 3.5 years

  4. Time to Stroke

    Time to stroke

    Measured: From randomization; for approximately a mean of 3.5 years

  5. Time to Hemorrhagic Stroke

    Time to hemorrhagic stroke

    Measured: From randomization; for approximately a mean of 3.5 years

  6. Time to Ischemic Stroke

    Time to ischemic stroke

    Measured: From randomization; for approximately a mean of 3.5 years

  7. Time to Unclassified Stroke

    Time to unclassified stroke

    Measured: From randomization; for approximately a mean of 3.5 years

  8. Time to Transient Ischemic Attack (TIA)

    Time to Transient Ischemic Attack (TIA)

    Measured: From randomization; for approximately a mean of 3.5 years

  9. Time to Renal Death

    Time to death from renal causes

    Measured: From randomization; for approximately a mean of 3.5 years

  10. Time to Renal Outcome

    Time to Renal Outcome, defined as a ≥50% reduction in the glomerular filtration rate (GFR) from baseline (excluding acute reversible causes) or progression to end-stage renal disease, which is defined as a GFR < 15 mL/min/1.73m² (excluding reversible causes) or the need for dialysis (hemodialysis or peritoneal dialysis for at least 30 days) or kidney transplantation.

    Measured: From randomization; for approximately a mean of 3.5 years

  11. Time to Cardiovascular Death

    Time to death from cardiovascular causes

    Measured: From randomization; for approximately a mean of 3.5 years

  12. Time to Myocardial Infarction (MI)

    Time to myocardial infarction (MI)

    Measured: From randomization; for approximately a mean of 3.5 years

  13. Time to Hospitalization due to Heart Failure

    Time to hospitalization due to heart failure

    Measured: From randomization; for approximately a mean of 3.5 years

  14. Time to Hospitalization due to Unstable Angina

    Time to Hospitalization due to unstable angina

    Measured: From randomization; for approximately a mean of 3.5 years

  15. Cognitive Impairment

    Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial assessment and last visit scores

    Measured: From initial assessment, for approximately a mean of 3.5 years

  16. Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia

    Occurrence of mild cognitive impairment or probable all-cause dementia

    Measured: From initial assessment, for approximately a mean of 3.5 years

  17. Time to Mild Cognitive Impairment

    Time to Mild Cognitive Impairment

    Measured: From initial assessment, for approximately a mean of 3.5 years

  18. Time to All-Cause Probable Dementia

    Time to all-cause probable dementia

    Measured: From initial assessment, for approximately a mean of 3.5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2019
  2. Study start5 Aug 2019
  3. Primary completion8 Jul 2026
  4. Study completion8 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
4,368 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04036409
Sponsor's protocol ID
OPTIMAL STROKE Trial
Other IDs
25000.019101/2018-12, 25000.002604/2021-54, 25000.156759/2023-71, 02805118.8.1001.0071
Acronym
OPTIMAL Stroke
Status last verified
Mar 2026
First submitted
26 Jul 2019
Last updated
13 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Silva GS, Machline-Carrion MJ, Santo K, Clares de Andrade JB, Martins E, Guimaraes P, Monfardini F, Nieri J, Assis SRL, Martins SCO, Pontes Neto OM, Feitosa ADM, Moro CHC, Fuchs SC, Gagliardi R, Silvestre O, Pereira Silva R, Antunes M, Alves MM, Minelli C, Maia LN, Bortolotto LA, Sousa MG, Drager LF, Bazan R, Vilela-Martin JF, Oliveira-Filho J, Zetola V, Avelar W, Carbonera LA, Braga GP, Conforto AB, Tavares CAM, Lima FO, Martins GL, Rebello LC, Rodgers A, Whelton PK, Fuchs FD, Berwanger O. Intensive blood-pressure control for the prevention of major cardiovascular events in stroke patients: rationale and design of the OPTIMAL-STROKE trial. Eur Stroke J. 2026 Oct 5;11(10):aakag118. doi: 10.1093/esj/aakag118.

    PubMed 42837286

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2022 Nov 18;11(11):CD010315. doi: 10.1002/14651858.CD010315.pub5.

    PubMed 36398903

  • Saiz LC, Gorricho J, Garjon J, Celaya MC, Erviti J, Leache L. Blood pressure targets for the treatment of people with hypertension and cardiovascular disease. Cochrane Database Syst Rev. 2020 Sep 9;9(9):CD010315. doi: 10.1002/14651858.CD010315.pub4.

    PubMed 32905623

Questions about this trial

What is this clinical trial studying?

A study of Ischemic Stroke and Blood Pressure, run by Hospital Israelita Albert Einstein at 30 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure [ Time Frame: From randomization; for approximately a mean of 3.5 years ] (time frame: From randomization; for approximately a mean of 3.5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04036409, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.

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