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| ID | Type | Description | Link |
|---|---|---|---|
| 25000.019101/2018-12 | Other Grant/Funding Number | Ministry of Health, Brazil (NUP#) | |
| 25000.002604/2021-54 | Other Grant/Funding Number | Ministry of Health, Brazil (NUP#) | |
| 25000.156759/2023-71 | Other Grant/Funding Number | Ministry of Health, Brazil (NUP#) | |
| 02805118.8.1001.0071 | Other Identifier | Plataforma Brasil (CAAE #) |
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| Name | Class |
|---|---|
| Ministry of Health, Brazil | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intensive Control of Systolic Blood Pressure (SBP) | Experimental | Participants randomized into the Intensive Blood Pressure arm will have a goal of SBP <120 mm Hg. |
|
| Standard Control of Systolic Blood Pressure | Active Comparator | Participants randomized into the Standard arm will have a goal of SBP <140 mm Hg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensive Control of Systolic Blood Pressure (SBP) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 ] | Time to first event of cardiovascular death, non-fatal myocardial infarction (MI) or non-fatal stroke | From randomization; for approximately a mean of 3.5 years |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Otavio Berwanger, MD, PhD | Hospital Israelita Albert Einstein | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clínica Silvestre Santé | Rio Branco | Acre | Brazil | |||
| Centro de Pesquisas Clinicas (Centro Universitário Cesmac / Hospital do Coração de Alagoas) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36398903 | Derived | 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. | |
| 32905623 | Derived | 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. |
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| Standard control of Systolic Blood Pressure (SBP) | Drug | The same medications used in the Intensive BP arm will be used for the Standard BP arm. |
|
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| 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 ] |
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 mean of 3.5 years |
| Time to Death | Time to all cause death | From randomization; for approximately a mean of 3.5 years |
| Time to Stroke | Time to stroke | From randomization; for approximately a mean of 3.5 years |
| Time to Hemorrhagic Stroke | Time to hemorrhagic stroke | From randomization; for approximately a mean of 3.5 years |
| Time to Ischemic Stroke | Time to ischemic stroke | From randomization; for approximately a mean of 3.5 years |
| Time to Unclassified Stroke | Time to unclassified stroke | From randomization; for approximately a mean of 3.5 years |
| Time to Transient Ischemic Attack (TIA) | Time to Transient Ischemic Attack (TIA) | From randomization; for approximately a mean of 3.5 years |
| Time to Renal Death | Time to death from renal causes | From randomization; for approximately a mean of 3.5 years |
| Time to Renal Outcome | Time to Renal Outcome, defined as a ≥50% reduction in the glomerular filtration rate (GFR) from baseline (excluding acute reversible causes) or progression to end-stage renal disease, which is defined as a GFR < 15 mL/min/1.73m² (excluding reversible causes) or the need for dialysis (hemodialysis or peritoneal dialysis for at least 30 days) or kidney transplantation. | From randomization; for approximately a mean of 3.5 years |
| Time to Cardiovascular Death | Time to death from cardiovascular causes | From randomization; for approximately a mean of 3.5 years |
| Time to Myocardial Infarction (MI) | Time to myocardial infarction (MI) | From randomization; for approximately a mean of 3.5 years |
| Time to Hospitalization due to Heart Failure | Time to hospitalization due to heart failure | From randomization; for approximately a mean of 3.5 years |
| Time to Hospitalization due to Unstable Angina | Time to Hospitalization due to unstable angina | From randomization; for approximately a mean of 3.5 years |
| Cognitive Impairment | Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial assessment and last visit scores | From initial assessment, for approximately a mean of 3.5 years |
| 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 initial assessment, for approximately a mean of 3.5 years |
| Time to Mild Cognitive Impairment | Time to Mild Cognitive Impairment | From initial assessment, for approximately a mean of 3.5 years |
| Time to All-Cause Probable Dementia | Time to all-cause probable dementia | From initial assessment, for approximately a mean of 3.5 years |
| 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 |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D060825 | Cognitive Dysfunction |
| D014652 | Vascular Diseases |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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