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

NCT ID: NCT04036409

Last Updated: 2024-01-03

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 4369 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-05
• Study Completion Date: 2025-12-31

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.

Conditions

Ischemic Stroke; Blood Pressure; Cognitive Impairment; Vascular Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Intensive Control of Systolic Blood Pressure (SBP)

Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP \<120 mm Hg.

Group Type: EXPERIMENTAL

Intensive Control of Systolic Blood Pressure (SBP)

Intervention Type: DRUG

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

Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg

Group Type: ACTIVE_COMPARATOR

Standard control of Systolic Blood Pressure (SBP)

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

Intensive BP control targeting SBP <120 mmHg.; Standard control of SBP targeting SBP < 140 mmHg

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ministry of Health, Brazil

OTHER_GOV

Sponsor Role: collaborator

Hospital Israelita Albert Einstein

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Otavio Berwanger, MD, PhD

Role: STUDY_DIRECTOR

Hospital Israelita Albert Einstein

Locations

Clínica Silvestre Santé

Rio Branco, Acre, Brazil

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

Maceió, Alagoas, Brazil

Hospital Geral de Fortaleza

Fortaleza, Ceará, Brazil

Universidade Federal do Ceará / Hospital Universitário Walter Cantídio

Fortaleza, Ceará, Brazil

Hospital Universitário Professor Edgard Santos

Salvador, Estado de Bahia, Brazil

Hospital Ana Nery

Salvador, Estado de Bahia, Brazil

Instituto Hospitalar de Base Do Distrito Federal

Brasília, Federal District, Brazil

Universidade Federal de Goias

Goiânia, Goiás, Brazil

Hospital Universitário Maria Aparecida Pedrossian - UFMS

Campo Grande, Mato Grosso do Sul, Brazil

Flumignano Instituto de Medicina

Curitiba, Paraná, Brazil

PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares

Recife, Pernambuco, Brazil

Hospital Moinho de Ventos

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital de Clínicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Governador Celso Ramos

Florianópolis, Santa Catarina, Brazil

Clínica Neurológica e Neurocirurgica de Joinville LTDA

Joinville, Santa Catarina, 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, Brazil

Universidade Estadual de Campinas - Hospital de Clínicas

Campinas, São Paulo, Brazil

Hospital Carlos Fernando Malzoni

Matão, São Paulo, Brazil

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

Ribeirão Preto, São Paulo, Brazil

Clínica Vilela e Martin

São José do Rio Preto, São Paulo, Brazil

Fundação Faculdade Regional de Medicina de São José do Rio Preto

São José do Rio Preto, São Paulo, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, São Paulo, Brazil

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

Botucatu, , Brazil

Hospital Universitário Pedro Ernesto - UERJ

Rio de Janeiro, , Brazil

Hospital das Clínicas da FMUSP

São Paulo, , Brazil

Instituto Dante Pazzanese de Cardiologia

São Paulo, , Brazil

Hospital São Paulo

São Paulo, , Brazil

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

São Paulo, , Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 36398903 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 32905623 (View on PubMed)

Other Identifiers

OPTIMAL STROKE Trial

Identifier Type: -

Identifier Source: org_study_id