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NCT Number: NCT04036409

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Silvestre Santé, Rio Branco, Acre, Brazil

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Intensive BP control targeting SBP <120 mmHg.

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.

Other names: Standard control of SBP targeting SBP < 140 mmHg

Primary outcomes

  1. 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 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

Secondary outcomes

  1. 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 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

  2. 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 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

  3. Time to Death

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to all cause death

  4. Time to Stroke

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to stroke

  5. Time to Hemorrhagic Stroke

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to hemorrhagic stroke

  6. Time to Ischemic Stroke

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to ischemic stroke

  7. Time to Unclassified Stroke

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to unclassified stroke

  8. Time to Transient Ischemic Attack (TIA)

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to Transient Ischemic Attack (TIA)

  9. Time to Renal Death

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to death from renal causes

  10. Time to Renal Outcome

    Time frame: From randomization; for approximately a mean of 3.5 years

    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.

  11. Time to Cardiovascular Death

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to death from cardiovascular causes

  12. Time to Myocardial Infarction (MI)

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to myocardial infarction (MI)

  13. Time to Hospitalization due to Heart Failure

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to hospitalization due to heart failure

  14. Time to Hospitalization due to Unstable Angina

    Time frame: From randomization; for approximately a mean of 3.5 years

    Time to Hospitalization due to unstable angina

  15. Cognitive Impairment

    Time frame: From initial assessment, for approximately a mean of 3.5 years

    Decline in the Montreal Cognitive Assessment (MoCA) score calculated as the difference between initial assessment and last visit scores

  16. Time to a Composite Outcome of Mild Cognitive Impairment or Probable All Cause Dementia

    Time frame: From initial assessment, for approximately a mean of 3.5 years

    Occurrence of mild cognitive impairment or probable all-cause dementia

  17. Time to Mild Cognitive Impairment

    Time frame: From initial assessment, for approximately a mean of 3.5 years

    Time to Mild Cognitive Impairment

  18. Time to All-Cause Probable Dementia

    Time frame: From initial assessment, for approximately a mean of 3.5 years

    Time to all-cause probable dementia

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Ministry of Health, Brazil

Registry information

Official study title

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

Acronym: OPTIMAL Stroke

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Jul 29, 2019
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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