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

Not Applicable

Active, not recruiting

• Conditions: Ischemic Stroke; Blood Pressure; Cognitive Impairment; Vascular Diseases
• Interventions: Drug: Intensive Control of Systolic Blood Pressure (SBP); Drug: Standard control of Systolic Blood Pressure (SBP)

• Registration Number: NCT04036409
• Lead Sponsor: Hospital Israelita Albert Einstein

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-26
• Study First Submitted QC: 2019-07-26
• Study First Posted: 2019-07-29
• Study Start: 2019-08-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-02
• Last Update Posted: 2024-01-03
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4369

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intensive Control of Systolic Blood Pressure (SBP)	Intensive Control of Systolic Blood Pressure (SBP)	Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP \<120 mm Hg.
Standard Control of Systolic Blood Pressure	Standard control of Systolic Blood Pressure (SBP)	Participants randomized into the Standard arm will have a goal of SBP \<140 mm Hg

Primary Outcome Measures

Name	Time	Method
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 ]	From randomization; for approximately a median 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

Secondary Outcome Measures

Name	Time	Method
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 ]	From randomization; for approximately a median of 3.5 years	Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke
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 ]	From randomization; for approximately a median 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
Time to non-fatal MI, non-fatal stroke, or total death	From randomization; for approximately a median of 3.5 years	Time to non-fatal MI, non-fatal stroke or total death.
Time to Death	From randomization; for approximately a median of 3.5 years	Time to all cause death
Time to Renal Death	From randomization; for approximately a median of 3.5 years	Time to death from renal causes
Time to Ischemic Stroke	From randomization; for approximately a median of 3.5 years	Time to ischemic stroke
Time to Unclassified Stroke	From randomization; for approximately a median of 3.5 years	Time to unclassified stroke
Time to Renal Outcome	From randomization; for approximately a median of 3.5 years	Time to Renal Outcome, defined as a 50% reduction in the glomerular filtration rate (GRF) associated with a final GFR of \< 60 mL/min/1.73m2 in patients without chronic kidney disease (GFR 60-90 mL/min/1.73m2) at baseline. In those patients with chronic kidney disease (\<60 mL/min/1.73m2) at baseline, the renal outcome will be defined as a 50% reduction in GFR or progression of renal disease to stage IV, requiring dialysis or kidney transplantation.
Time to Cardiovascular Death	From randomization; for approximately a median of 3.5 years	Time to death from cardiovascular causes
Time to Stroke	From randomization; for approximately a median of 3.5 years	Time to stroke
Time to Hemorrhagic Stroke	From randomization; for approximately a median of 3.5 years	Time to hemorrhagic stroke
Time to Transient Ischemic Attack (TIA)	From randomization; for approximately a median of 3.5 years	Time to Transient Ischemic Attack (TIA)
Time to Myocardial Infarction (MI)	From randomization; for approximately a median of 3.5 years	Time to myocardial infarction (MI)
Time to Hospitalization due to Heart Failure	From randomization; for approximately a median of 3.5 years	Time to hospitalization due to heart failure
Time to Hospitalization due to Unstable Angina	From randomization; for approximately a median of 3.5 years	Time to Hospitalization due to unstable angina
Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia	From randomization; for approximately a median of 3.5 years	Occurrence of mild cognitive impairment or probable all-cause dementia
Time to Mild Cognitive Impairment	From randomization; for approximately a median of 3.5 years	Time to Mild Cognitive Impairment
Time to All-Cause Probable Dementia	From randomization; for approximately a median of 3.5 years	Time to all-cause probable dementia

Trial Locations

Locations (29)

Clínica Silvestre Santé; 🇧🇷 Rio Branco, Acre, Brazil

Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas); 🇧🇷 Maceió, Alagoas, Brazil

Hospital de Clínicas de Porto Alegre; 🇧🇷 Porto Alegre, Rio Grande Do Sul, 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, Bahia, Brazil

Hospital Ana Nery; 🇧🇷 Salvador, Bahia, Brazil

Hospital Governador Celso Ramos; 🇧🇷 Florianópolis, Santa Catarina, Brazil

Hospital Universitário Maria Aparecida Pedrossian - UFMS; 🇧🇷 Campo Grande, Mato Grosso Do Sul, Brazil

Clínica Neurológica e Neurocirurgica de Joinville LTDA; 🇧🇷 Joinville, Santa Catarina, Brazil

Hospital Moinho de Ventos; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil

CMEP Centro Multidisciplinar de Ensino Especializado e Pesquisa Ltda; 🇧🇷 Joinville, Santa Catarina, 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

Hospital das Clínicas da FMUSP; 🇧🇷 São Paulo, Brazil

Instituto Hospitalar de Base Do Distrito Federal; 🇧🇷 Brasilia, DF, Brazil

Universidade Federal de Goias; 🇧🇷 Goiânia, Goiás, Brazil

Irmandade da Santa Casa de Misericórdia de São Paulo; 🇧🇷 São Paulo, SP, 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

Fundação Faculdade Regional de Medicina de São José do Rio Preto; 🇧🇷 São José Do Rio Preto, 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 São Paulo; 🇧🇷 São Paulo, Brazil

Instituto Dante Pazzanese de Cardiologia; 🇧🇷 São Paulo, Brazil

InCor - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP; 🇧🇷 São Paulo, Brazil

Flumignano Instituto de Medicina; 🇧🇷 Curitiba, Paraná, Brazil

PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares; 🇧🇷 Recife, Pernambuco, Brazil