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
Sites (29)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP Coordinator of this site? Confirm its status | Botucatu | Brazil | Unknown status |
| Hospital Univ. São Francisco de Assis na Providencia de Deus Coordinator of this site? Confirm its status | Bragança Paulista | Brazil | Unknown status |
| Instituto Hospitalar de Base Do Distrito Federal Coordinator of this site? Confirm its status | Brasília | Brazil | Unknown status |
| Universidade Estadual de Campinas - Hospital de Clínicas Coordinator of this site? Confirm its status | Campinas | Brazil | Unknown status |
| Hospital Universitário Maria Aparecida Pedrossian - UFMS Coordinator of this site? Confirm its status | Campo Grande | Brazil | Unknown status |
| Flumignano Instituto de Medicina Coordinator of this site? Confirm its status | Curitiba | Brazil | Unknown status |
| Hospital Governador Celso Ramos Coordinator of this site? Confirm its status | Florianópolis | Brazil | Unknown status |
| Hospital Geral de Fortaleza Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Universidade Federal do Ceará / Hospital Universitário Walter Cantídio Coordinator of this site? Confirm its status | Fortaleza | Brazil | Unknown status |
| Universidade Federal de Goias Coordinator of this site? Confirm its status | Goiânia | Brazil | Unknown status |
| CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Clinica Neurologica e Neurocirurgica de Joinville Ltda Coordinator of this site? Confirm its status | Joinville | Brazil | Unknown status |
| Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas) Coordinator of this site? Confirm its status | Maceió | Brazil | Unknown status |
| Hospital Carlos Fernando Malzoni Coordinator of this site? Confirm its status | Matão | Brazil | Unknown status |
| Hospital Moinho de Ventos Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| Hospital de Clinicas de Porto Alegre Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares Coordinator of this site? Confirm its status | Recife | Brazil | Unknown status |
| Hospital Das Clinicas da Faculdade de Medicina de Ribeirao Preto - Universidade de Sao Paulo Coordinator of this site? Confirm its status | Ribeirão Preto | Brazil | Unknown status |
| Clínica Silvestre Sante Coordinator of this site? Confirm its status | Rio Branco | Brazil | Unknown status |
| Hospital Universitario Pedro Ernesto - UERJ Coordinator of this site? Confirm its status | Rio de Janeiro | Brazil | Unknown status |
| Hospital Universitário Professor Edgard Santos Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Hospital Ana Nery Coordinator of this site? Confirm its status | Salvador | Brazil | Unknown status |
| Clínica Vilela e Martin Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto Coordinator of this site? Confirm its status | São José do Rio Preto | Brazil | Unknown status |
| Hospital das Clínicas da FMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Instituto Dante Pazzanese de Cardiologia Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Irmandade da Santa Casa de Misericórdia de São Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Hospital Sao Paulo Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.