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

April 13, 2026 updated by: Hospital Israelita Albert Einstein

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4368

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Acre
      • Rio Branco, Acre, Brazil
        • Clínica Silvestre Santé
    • Alagoas
      • Maceió, Alagoas, Brazil
        • Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
    • Botucatu
      • Botucatu, Botucatu, Brazil, 18618-686
        • UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
    • Ceará
      • Fortaleza, Ceará, Brazil, 60175-295
        • Hospital Geral de Fortaleza
      • Fortaleza, Ceará, Brazil, 60430-372
        • Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40323-010
        • Hospital Ana Nery
      • Salvador, Estado de Bahia, Brazil, 40110-060
        • Hospital Universitario Professor Edgard Santos
    • Federal District
      • Brasília, Federal District, Brazil, 70335900
        • Instituto Hospitalar de Base Do Distrito Federal
    • Goiás
      • Goiânia, Goiás, Brazil, 74690-900
        • Universidade Federal de Goias
    • Mato Grosso do Sul
      • Campo Grande, Mato Grosso do Sul, Brazil, 79080-190
        • Hospital Universitário Maria Aparecida Pedrossian - UFMS
    • Paraná
      • Curitiba, Paraná, Brazil, 82590-300
        • Flumignano Instituto de Medicina
    • Pernambuco
      • Recife, Pernambuco, Brazil, 74970-240
        • PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-007
        • Hospital de Clínicas de Porto Alegre
      • Porto Alegre, Rio Grande do Sul, Brazil, 90035-000
        • Hospital Moinho de Ventos
    • Rio de Janeiro
      • Rio de Janeiro, Rio de Janeiro, Brazil, 20551-030
        • Hospital Universitario Pedro Ernesto - UERJ
    • Santa Catarina
      • Florianópolis, Santa Catarina, Brazil, 88015-270
        • Hospital Governador Celso Ramos
      • Joinville, Santa Catarina, Brazil, 89202-165
        • Clínica Neurológica e Neurocirurgica de Joinville LTDA
      • Joinville, Santa Catarina, Brazil
        • CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916-542
        • Hospital Univ. São Francisco de Assis na Providencia de Deus
      • Campinas, São Paulo, Brazil, 13083-888
        • Universidade Estadual de Campinas - Hospital de Clínicas
      • Matão, São Paulo, Brazil, 15990-060
        • Hospital Carlos Fernando Malzoni
      • Ribeirão Preto, São Paulo, Brazil, 14015-010
        • Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
      • São José do Rio Preto, São Paulo, Brazil, 15090-365
        • Clínica Vilela e Martin
      • São José do Rio Preto, São Paulo, Brazil, 150900000
        • Fundação Faculdade Regional de Medicina de São José do Rio Preto
      • São Paulo, São Paulo, Brazil, 04037-002
        • Hospital Sao Paulo
      • São Paulo, São Paulo, Brazil, 04012-909
        • Instituto Dante Pazzanese de Cardiologia
      • São Paulo, São Paulo, Brazil, (11) 2661-0000
        • Hospital das Clínicas da FMUSP
      • São Paulo, São Paulo, Brazil, 01221-020
        • Irmandade Da Santa Casa De Misericordia De Sao Paulo
      • São Paulo, São Paulo, Brazil, 05403-900
        • InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intensive Control of Systolic Blood Pressure (SBP)
Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg.
Drug: 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
Other Names:
  • Intensive BP control targeting SBP <120 mmHg.
Active Comparator: Standard Control of Systolic Blood Pressure
Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg
Drug: Standard control of Systolic Blood Pressure (SBP)
The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Other Names:
  • Standard control of SBP targeting SBP < 140 mmHg

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Time to first event of cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure
From randomization; for approximately a mean of 3.5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 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
From randomization; for approximately a mean of 3.5 years
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 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
From randomization; for approximately a mean of 3.5 years
Time to Death
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to all cause death
From randomization; for approximately a mean of 3.5 years
Time to Stroke
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to stroke
From randomization; for approximately a mean of 3.5 years
Time to Hemorrhagic Stroke
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to hemorrhagic stroke
From randomization; for approximately a mean of 3.5 years
Time to Ischemic Stroke
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to ischemic stroke
From randomization; for approximately a mean of 3.5 years
Time to Unclassified Stroke
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to unclassified stroke
From randomization; for approximately a mean of 3.5 years
Time to Transient Ischemic Attack (TIA)
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to Transient Ischemic Attack (TIA)
From randomization; for approximately a mean of 3.5 years
Time to Renal Death
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to death from renal causes
From randomization; for approximately a mean of 3.5 years
Time to Renal Outcome
Time Frame: From randomization; for approximately a mean of 3.5 years
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.
From randomization; for approximately a mean of 3.5 years
Time to Cardiovascular Death
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to death from cardiovascular causes
From randomization; for approximately a mean of 3.5 years
Time to Myocardial Infarction (MI)
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to myocardial infarction (MI)
From randomization; for approximately a mean of 3.5 years
Time to Hospitalization due to Heart Failure
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to hospitalization due to heart failure
From randomization; for approximately a mean of 3.5 years
Time to Hospitalization due to Unstable Angina
Time Frame: From randomization; for approximately a mean of 3.5 years
Time to Hospitalization due to unstable angina
From randomization; for approximately a mean of 3.5 years
Cognitive Impairment
Time Frame: From initial assessment, for approximately a mean of 3.5 years
Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial assessment and last visit scores
From initial assessment, for approximately a mean of 3.5 years
Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia
Time Frame: From initial assessment, for approximately a mean of 3.5 years
Occurrence of mild cognitive impairment or probable all-cause dementia
From initial assessment, for approximately a mean of 3.5 years
Time to Mild Cognitive Impairment
Time Frame: From initial assessment, for approximately a mean of 3.5 years
Time to Mild Cognitive Impairment
From initial assessment, for approximately a mean of 3.5 years
Time to All-Cause Probable Dementia
Time Frame: From initial assessment, for approximately a mean of 3.5 years
Time to all-cause probable dementia
From initial assessment, for approximately a mean of 3.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Health, Brazil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Otavio Berwanger, MD, PhD, Hospital Israelita Albert Einstein

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 5, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OPTIMAL STROKE Trial
  • 25000.019101/2018-12 (Other Grant/Funding Number: Ministry of Health, Brazil (NUP#))
  • 25000.002604/2021-54 (Other Grant/Funding Number: Ministry of Health, Brazil (NUP#))
  • 25000.156759/2023-71 (Other Grant/Funding Number: Ministry of Health, Brazil (NUP#))
  • 02805118.8.1001.0071 (Other Identifier: Plataforma Brasil (CAAE #))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Vascular Diseases

Clinical Trials on Standard control of Systolic Blood Pressure (SBP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings