Clinical trial NCT04036409: Optimal Blood Pressure for the prevenTIon of Major vAscuLar Events in Stroke Patients
Official title: A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Ischemic Stroke
Blood Pressure
Cognitive Impairment
Vascular Diseases
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Brazil
First posted: 2019-07-29
Enrollment: 4369
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
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 median of 3.5 years ]
timeFrame: From randomization; for approximately a median of 3.5 years
Secondary outcomes:
measure: Time to cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke [ Time Frame: From randomization; for approximately a median of 3.5 years ]
timeFrame: From randomization; for approximately a median of 3.5 years
measure: 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 median of 3.5 years ]
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to non-fatal MI, non-fatal stroke, or total death
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Death
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Renal Death
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Renal Outcome
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Cardiovascular Death
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Stroke
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Hemorrhagic Stroke
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Ischemic Stroke
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Unclassified Stroke
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Transient Ischemic Attack (TIA)
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Myocardial Infarction (MI)
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Hospitalization due to Heart Failure
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Hospitalization due to Unstable Angina
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to Mild Cognitive Impairment
timeFrame: From randomization; for approximately a median of 3.5 years
measure: Time to All-Cause Probable Dementia
timeFrame: From randomization; for approximately a median of 3.5 years
Other outcomes:
Locations:
city: Rio Branco
country: Brazil
facility: Clínica Silvestre Santé
state: Acre
city: Maceió
country: Brazil
facility: Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)
state: Alagoas
city: Salvador
country: Brazil
facility: Hospital Universitário Professor Edgard Santos
state: Bahia
city: Salvador
country: Brazil
facility: Hospital Ana Nery
state: Bahia
city: Fortaleza
country: Brazil
facility: Hospital Geral de Fortaleza
state: Ceará
city: Fortaleza
country: Brazil
facility: Universidade Federal do Ceará / Hospital Universitário Walter Cantídio
state: Ceará
city: Brasilia
country: Brazil
facility: Instituto Hospitalar de Base Do Distrito Federal
state: DF
city: Goiânia
country: Brazil
facility: Universidade Federal de Goias
state: Goiás
city: Campo Grande
country: Brazil
facility: Hospital Universitário Maria Aparecida Pedrossian - UFMS
state: Mato Grosso Do Sul
city: Curitiba
country: Brazil
facility: Flumignano Instituto de Medicina
state: Paraná
city: Recife
country: Brazil
facility: PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares
state: Pernambuco
city: Porto Alegre
country: Brazil
facility: Hospital Moinho de Ventos
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital de Clínicas de Porto Alegre
state: Rio Grande Do Sul
city: Florianópolis
country: Brazil
facility: Hospital Governador Celso Ramos
state: Santa Catarina
city: Joinville
country: Brazil
facility: Clínica Neurológica e Neurocirurgica de Joinville LTDA
state: Santa Catarina
city: Joinville
country: Brazil
facility: CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda
state: Santa Catarina
city: São Paulo
country: Brazil
facility: Irmandade da Santa Casa de Misericórdia de São Paulo
state: SP
city: Bragança Paulista
country: Brazil
facility: Hospital Univ. São Francisco de Assis na Providencia de Deus
state: São Paulo
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas - Hospital de Clínicas
state: São Paulo
city: Matão
country: Brazil
facility: Hospital Carlos Fernando Malzoni
state: São Paulo
city: Ribeirão Preto
country: Brazil
facility: Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Clínica Vilela e Martin
state: São Paulo
city: São José Do Rio Preto
country: Brazil
facility: Fundação Faculdade Regional de Medicina de São José do Rio Preto
state: São Paulo
city: Botucatu
country: Brazil
facility: UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitário Pedro Ernesto - UERJ
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
city: São Paulo
country: Brazil
facility: Hospital São Paulo
city: São Paulo
country: Brazil
facility: InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
Study officials:
affiliation: Hospital Israelita Albert Einstein
name: Otavio Berwanger, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.