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

Ischemic Stroke Clinical Trial

— OPTIMAL Stroke  

Official title:

A Randomized Controlled Trial to Assess the Effect of Intensive Blood Pressure Control on Major Cardiovascular Events in Stroke Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04036409
• Other study ID #: OPTIMAL STROKE Trial
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 5, 2019
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 4369
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Blood Pressure
• Cognitive Impairment
• Ischemic Stroke
• Stroke
• Vascular Diseases

Intervention

Drug:
• 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
• Standard control of Systolic Blood Pressure (SBP)
The same medications used in the Intensive BP arm will be used for the Standard BP arm.

Locations

Country	Name	City	State
Brazil	UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - FMB/UNESP	Botucatu
Brazil	Hospital Univ. São Francisco de Assis na Providencia de Deus	Bragança Paulista	São Paulo
Brazil	Instituto Hospitalar de Base Do Distrito Federal	Brasilia	DF
Brazil	Universidade Estadual de Campinas - Hospital de Clínicas	Campinas	São Paulo
Brazil	Hospital Universitário Maria Aparecida Pedrossian - UFMS	Campo Grande	Mato Grosso Do Sul
Brazil	Flumignano Instituto de Medicina	Curitiba	Paraná
Brazil	Hospital Governador Celso Ramos	Florianópolis	Santa Catarina
Brazil	Hospital Geral de Fortaleza	Fortaleza	Ceará
Brazil	Universidade Federal do Ceará / Hospital Universitário Walter Cantídio	Fortaleza	Ceará
Brazil	Universidade Federal de Goias	Goiânia	Goiás
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	Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas)	Maceió	Alagoas
Brazil	Hospital Carlos Fernando Malzoni	Matão	São Paulo
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 Moinho de Ventos	Porto Alegre	Rio Grande Do Sul
Brazil	PROCAPE-Pronto Socorro Cardiológico de PE Prof. Luiz Tavares	Recife	Pernambuco
Brazil	Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - Universidade de São Paulo	Ribeirão Preto	São Paulo
Brazil	Clínica Silvestre Santé	Rio Branco	Acre
Brazil	Hospital Universitário Pedro Ernesto - UERJ	Rio de Janeiro
Brazil	Hospital Ana Nery	Salvador	Bahia
Brazil	Hospital Universitário Professor Edgard Santos	Salvador	Bahia
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	Hospital das Clínicas da FMUSP	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	Instituto Dante Pazzanese de Cardiologia	São Paulo
Brazil	Irmandade da Santa Casa de Misericórdia de São Paulo	São Paulo	SP

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Ministry of Health, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ]	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 median of 3.5 years
Secondary	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 ]	Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke	From randomization; for approximately a median of 3.5 years
Secondary	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 ]	Time to first event of total death, non-fatal myocardial infarction (MI), non-fatal stroke, hospitalization for unstable angina or hospitalization for heart failure	From randomization; for approximately a median of 3.5 years
Secondary	Time to non-fatal MI, non-fatal stroke, or total death	Time to non-fatal MI, non-fatal stroke or total death.	From randomization; for approximately a median of 3.5 years
Secondary	Time to Death	Time to all cause death	From randomization; for approximately a median of 3.5 years
Secondary	Time to Renal Death	Time to death from renal causes	From randomization; for approximately a median of 3.5 years
Secondary	Time to Renal Outcome	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.	From randomization; for approximately a median of 3.5 years
Secondary	Time to Cardiovascular Death	Time to death from cardiovascular causes	From randomization; for approximately a median of 3.5 years
Secondary	Time to Stroke	Time to stroke	From randomization; for approximately a median of 3.5 years
Secondary	Time to Hemorrhagic Stroke	Time to hemorrhagic stroke	From randomization; for approximately a median of 3.5 years
Secondary	Time to Ischemic Stroke	Time to ischemic stroke	From randomization; for approximately a median of 3.5 years
Secondary	Time to Unclassified Stroke	Time to unclassified stroke	From randomization; for approximately a median of 3.5 years
Secondary	Time to Transient Ischemic Attack (TIA)	Time to Transient Ischemic Attack (TIA)	From randomization; for approximately a median of 3.5 years
Secondary	Time to Myocardial Infarction (MI)	Time to myocardial infarction (MI)	From randomization; for approximately a median of 3.5 years
Secondary	Time to Hospitalization due to Heart Failure	Time to hospitalization due to heart failure	From randomization; for approximately a median of 3.5 years
Secondary	Time to Hospitalization due to Unstable Angina	Time to Hospitalization due to unstable angina	From randomization; for approximately a median of 3.5 years
Secondary	Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia	Occurrence of mild cognitive impairment or probable all-cause dementia	From randomization; for approximately a median of 3.5 years
Secondary	Time to Mild Cognitive Impairment	Time to Mild Cognitive Impairment	From randomization; for approximately a median of 3.5 years
Secondary	Time to All-Cause Probable Dementia	Time to all-cause probable dementia	From randomization; for approximately a median of 3.5 years