Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
OPTIMAL Stroke
A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
5 other identifiers
interventional
4,368
1 country
30
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2019
Longer than P75 for not_applicable
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedStudy Start
First participant enrolled
August 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 28, 2026
April 16, 2026
March 1, 2026
6.8 years
July 26, 2019
April 13, 2026
Conditions
Outcome Measures
Primary Outcomes (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
From randomization; for approximately a mean of 3.5 years
Secondary Outcomes (18)
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 ]
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 ]
From randomization; for approximately a mean of 3.5 years
Time to Death
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
From randomization; for approximately a mean of 3.5 years
- +13 more secondary outcomes
Study Arms (2)
Intensive Control of Systolic Blood Pressure (SBP)
EXPERIMENTALParticipants randomized into the Intensive Blood Pressure arm will have a goal of SBP \<120 mm Hg.
Standard Control of Systolic Blood Pressure
ACTIVE COMPARATORParticipants randomized into the Standard arm will have a goal of SBP \<140 mm Hg
Interventions
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
The same medications used in the Intensive BP arm will be used for the Standard BP arm.
Eligibility Criteria
You may qualify if:
- Systolic Blood Pressure (SBP) between 130 and 180 mmHg:
- and use of up to one antihypertensive drug;
- and use of up to two drugs;
- and use of up to three drugs;
- and use of up to four drugs. AND
You may not qualify if:
- 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.
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hospital Israelita Albert Einsteinlead
- Ministry of Health, Brazilcollaborator
Study Sites (30)
Clínica Silvestre Santé
Rio Branco, Acre, Brazil
Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
Maceió, Alagoas, Brazil
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
Botucatu, Botucatu, 18618-686, Brazil
Hospital Geral de Fortaleza
Fortaleza, Ceará, 60175-295, Brazil
Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
Fortaleza, Ceará, 60430-372, Brazil
Hospital Universitário Professor Edgard Santos
Salvador, Estado de Bahia, 40110-060, Brazil
Hospital Ana Nery
Salvador, Estado de Bahia, 40323-010, Brazil
Instituto Hospitalar de Base Do Distrito Federal
Brasília, Federal District, 70335900, Brazil
Universidade Federal de Goias
Goiânia, Goiás, 74690-900, Brazil
Hospital Universitário Maria Aparecida Pedrossian - UFMS
Campo Grande, Mato Grosso do Sul, 79080-190, Brazil
Flumignano Instituto de Medicina
Curitiba, Paraná, 82590-300, Brazil
PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
Recife, Pernambuco, 74970-240, Brazil
Hospital Universitário Pedro Ernesto - UERJ
Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil
Hospital Moinho de Ventos
Porto Alegre, Rio Grande do Sul, 90035-000, 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
Hospital Governador Celso Ramos
Florianópolis, Santa Catarina, 88015-270, Brazil
Clínica Neurológica e Neurocirurgica de Joinville LTDA
Joinville, Santa Catarina, 89202-165, Brazil
CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
Joinville, Santa Catarina, Brazil
Hospital Univ. São Francisco de Assis na Providencia de Deus
Bragança Paulista, São Paulo, 12916-542, Brazil
Universidade Estadual de Campinas - Hospital de Clínicas
Campinas, São Paulo, 13083-888, Brazil
Hospital Carlos Fernando Malzoni
Matão, São Paulo, 15990-060, Brazil
Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
Ribeirão Preto, São Paulo, 14015-010, Brazil
Clínica Vilela e Martin
São José do Rio Preto, São Paulo, 15090-365, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, 150900000, Brazil
Hospital das Clínicas da FMUSP
São Paulo, São Paulo, (11) 2661-0000, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, São Paulo, 01221-020, Brazil
Instituto Dante Pazzanese de Cardiologia
São Paulo, São Paulo, 04012-909, Brazil
Hospital São Paulo
São Paulo, São Paulo, 04037-002, Brazil
InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
São Paulo, São Paulo, 05403-900, Brazil
Related Publications (2)
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.
PMID: 36398903DERIVEDSaiz 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.
PMID: 32905623DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Otavio Berwanger, MD, PhD
Hospital Israelita Albert Einstein
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 26, 2019
First Posted
July 29, 2019
Study Start
August 5, 2019
Primary Completion (Estimated)
May 28, 2026
Study Completion (Estimated)
May 28, 2026
Last Updated
April 16, 2026
Record last verified: 2026-03